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Stem cells: Could we gain the power to induce cell regeneration? Dr Catherine Berry – The Scotsman

In short, stem cells initiate the production of new tissue cells, which can then replace their diseased counterparts.

Mesenchymal stem cells (MSCs) are adult stem cells found in many areas of the body such as bone marrow. The unique thing about these cells is their compatibility with a range of tissues such as bone, cartilage, muscle, or fat. MSCs respond to injury or disease by migrating to these damaged areas, where they restore tissue function by replacing the damaged cells.

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It has recently been shown that the success of MSCs relies on their ability to release cell signals their mechanism to initiate tissue regeneration. These signals are packaged into extracellular vehicles (EVs) which are essentially bubbles of information. These are released by MSCs and taken up by the injured or diseased tissue cells to kickstart their inbuilt process of regeneration.

Through funding from the Royal Society of Edinburgh, research has started into the development of artificial EVs as a viable alternative to cell therapy. These EVs will contain the key molecules released by stem cells when they are responding to injury cues in the body.

The power to induce tissue regeneration would provide a significant new tool in biomedical treatment, such as incorporating EVs into synthetic hydrogels within a wound dressing to encourage and accelerate healing.

Within the lab setting, we have been able to manipulate stem cell cultures to produce EVs with different signal make-ups, and accurately identify their properties.

Controlling and identifying the different make-ups contained in EV signals which in turn induce different cell responses is crucial if we want to operationalise their use in medicine.

We now aim to synthesise artificial vesicles, or bubbles, for different clinical problems, such as, for example, bubbles with potent wound-healing properties that would help our ability to use new artificial stem cell therapy.

The research is underway and it is showing promise that we may be able to harness the regenerative power of stem cells in the near future.

An artificial EV-based approach also has several advantages over stem cell-based therapies, such as having increased potency and greater consistency in treatment, and at a lower cost to carry out.

Both inside and on the surface of the body, we would have the ability to induce a process vital to medical treatment we work with every day and, in turn, open a whole new avenue of possibilities in biomedical science.

Dr Catherine Berry is a reader in the Centre for the Cellular Microenvironment at the University of Glasgow, and a recipient of the Royal Society of Edinburghs personal research fellowship in 2021. This article expresses her own views. The RSE is Scotland's national academy, bringing great minds together to contribute to the social, cultural and economic well-being of Scotland. Find out more at rse.org.uk and @RoyalSocEd.

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Stem cells: Could we gain the power to induce cell regeneration? Dr Catherine Berry - The Scotsman

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Verb Technology (VERB) Stock: Why It Jumped Up 15.07% Today – Pulse 2.0

The stock price of Verb Technology Company Inc (VERB) an innovative nutraceutical company and a pioneer in the field of stem cell nutrition increased by 15.07% today. Investors responded positively to Stemtech Corporation announcing that Stemtech has adopted a suite of sales enablement software solutions, developed by Verb Technology Company, including verbCRM, VERBs white-labeled interactive video-based customer relationship management application, and verbLIVE, VERBs interactive livestream eCommerce and shoppable video and webinar application, for use in direct selling and customer and prospect communications by its network of Independent Business Partners (IBPs).

Stemtech specializes in creating products and formulas that are patent protected in the U.S. and international markets. And its patented formulas help the release, circulation and migration of the bodys adult stem cells from its bone marrow. The products are all-natural, plant-based, and manufactured under cGMP (Current Good Manufacturing Practices) under the auspices of the Dietary Supplemental Health and Education Act (DSHEA). Stemtechs primary marketing and distribution channel are through a direct sales structure, which offers supplemental and residual income-earning potential to IBPs.

VERB is the leader in interactive video-based sales enablement applications, including interactive livestream eCommerce and shoppable video, webinar, CRM, and marketing applications for enterprises and entrepreneurs., verbCRM, VERBs interactive video-based customer relationship and content management system, will be used as a selling tool by Stemtechs IBPs in marketing its products, acquiring new customers, and strengthening existing customer relationships. And the platform allows users to easily manage, share directly with customers and prospects and through social media, and track interactive content, such as product literature and media, demo videos, and personalized videos.

Plus it provides interaction analytics so IBPs can determine which content is resonating with their prospects and assess overall customer engagement and campaign effectiveness. And this enables IBPs to focus their time and energy more effectively on high-probability sales prospects who have shown interest, thereby increasing their sales conversion rates.

Stemtechs verbCRM implementation also includes VERBs Business Tiles feature, which integrates verbCRM directly into Stemtechs back-office systems, allowing IBPs access to key reports and metrics relevant to improving their business-building efforts natively on the verbCRM app. And verbLIVE, VERBs powerful interactive livestream e-commerce application, will be used by IBPs to engage directly with customers and prospects during live video sessions that allow viewers to quickly buy, receive additional product information, set up appointments, and access other customizable interactive features through clickable in-video buttons.

KEY QUOTES:

We are dedicated to supporting and empowering Stemtechs expansive network of Independent Business Partners by equipping them with the most current and best-in-class digital technology sales tools available. With VERBs sales enablement applications, our IBPs will be able to capitalize on our social media assets and content and more effectively engage with customers and prospects via livestream video to bolster our customer acquisition efforts and increase sales conversion rates.

John Meyer, President and COO of Stemtech

Our select Field IBPs who have been beta testing the new mobile app Stemtech Advance Office, powered by VERB, has been very successful and we are all most excited to launch shortly.

Stemtechs Vice President of Global Performance Sandra Kazickaite

We are thrilled to include Stemtech among the forward-thinking companies that have embraced VERBs interactive video and livestreaming technology to grow sales. VERB has developed a suite of easy-to-use products that create a friction-free, fun, social, and video-based sales experience to enhance customer engagement, while providing real-time viewer engagement analytics for more effective follow-ups that drive sales conversion rates. We are proud to be Stemtechs technology partner to help empower its Independent Business Partners with industry-leading sales enablement tools.

Rory Cutaia, CEO of VERB

Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.

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Verb Technology (VERB) Stock: Why It Jumped Up 15.07% Today - Pulse 2.0

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Global Stem Cell Banking Market To Be Driven At A CAGR Of 13.5% In The Forecast Period Of 2021-2026 This Is Ardee – This Is Ardee

The new report by Expert Market Research titled, Global Stem Cell Banking Market Report and Forecast 2021-2026, gives an in-depth analysis of the globalstem cell banking market, assessing the market based on its segments like Service type, product type, utilisation, bank type, application, and major regions like Asia Pacific, Europe, North America, Middle East and Africa and Latin America. The report tracks the latest trends in the industry and studies their impact on the overall market. It also assesses the market dynamics, covering the key demand and price indicators, along with analysing the market based on the SWOT and Porters Five Forces models.

Request a free sample copy in PDF or view the report summary@https://bityl.co/CPix

The key highlights of the report include:

Market Overview (2021-2026)

The global stem cell bank market is primarily driven by the advancements in the field of medicine and the rising prevalence of genetic and degenerativediseases. Further, the increasing research and development of more effective technologies for better preservation, processing, and storage of stem cells are aiding the growth. Additionally, rising prevalence of chronic diseases globally is increasing the for advances inmedicaltechnologies, thus pushing the growth further. Moreover, factors such as rising health awareness, developinghealthcare infrastructure, growing geriatric population, and the inflatingdisposableincomes are expected to propel the market in the forecast period.

Industry Definition and Major Segments

Stem cells are undifferentiated cells present in bone marrow,umbilical cordadipose tissue and blood. They have the ability to of differentiate and regenerate. The process of storing and preserving these cells for various application such as gene therapy, regenerative medicine and tissue engineering is known as stem cell banking.

Explore the full report with the table of contents@https://bityl.co/CPiy

By service type, the market is divided into:

Based on product type, the industry can be segmented into:

The market is bifurcated based on utilization into:

By bank type, the industry can be broadly categorized into:

Based on application, the industry can be segmented into:

On the basis of regional markets, the industry is divided into:

1 North America1.1 United States of America1.2 Canada2 Europe2.1 Germany2.2 United Kingdom2.3 France2.4 Italy2.5 Others3 Asia Pacific3.1 China3.2 Japan3.3 India3.4 ASEAN3.5 Others4 Latin America4.1 Brazil4.2 Argentina4.3 Mexico4.4 Others5 Middle East & Africa5.1 Saudi Arabia5.2 United Arab Emirates5.3 Nigeria5.4 South Africa5.5 Others

Market Trends

Regionally, North America is projected to dominate the global stem cell bank market and expand at a significant rate. This can be attributed to increasing research and development for stem cell application in various medical fields. Further, growing investments of pharmaceutical players and development infrastructure are other factors that are expected to stem cell bank market in the region. Meanwhile, Asia Pacific market is also expected to witness fast growth owing to the rapid development in healthcare facilities and increasing awareness of stem cell banking in countries such as China, India, and Indonesia.

Key Market Players

The major players in the market are Cryo-Cell International, Inc., Smart Cells International Ltd., CSG-BIO Company, Inc., CBR Systems Inc., ViaCord, LLC, LifeCell International Pvt. Ltd., and a few others. The report covers the market shares, capacities, plant turnarounds, expansions, investments and mergers and acquisitions, among other latest developments of these market players.

About Us:

Expert Market Research (EMR) is leading market research company with clients across the globe. Through comprehensive data collection and skilful analysis and interpretation of data, the company offers its clients extensive, latest and actionable market intelligence which enables them to make informed and intelligent decisions and strengthen their position in the market. The clientele ranges from Fortune 1000 companies to small and medium scale enterprises.

EMR customises syndicated reports according to clients requirements and expectations. The company is active across over 15 prominent industry domains, including food and beverages, chemicals and materials, technology and media, consumer goods, packaging, agriculture, and pharmaceuticals, among others.

Over 3000 EMR consultants and more than 100 analysts work very hard to ensure that clients get only the most updated, relevant, accurate and actionable industry intelligence so that they may formulate informed, effective and intelligent business strategies and ensure their leadership in the market.

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Company Name: Claight CorporationContact Person: Steven Luke, Corporate Sales Specialist U.S.A.Email:sales@expertmarketresearch.comToll Free Number: +1-415-325-5166 | +44-702-402-5790Address: 30 North Gould Street, Sheridan, WY 82801, USAWebsite:https://www.expertmarketresearch.com

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*We at Expert Market Research always thrive to give you the latest information. The numbers in the article are only indicative and may be different from the actual report.

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Global Stem Cell Banking Market To Be Driven At A CAGR Of 13.5% In The Forecast Period Of 2021-2026 This Is Ardee - This Is Ardee

Recommendation and review posted by Bethany Smith

S’porean doctor, a sought-after top expert in cell therapy, appointed to WHO expert panel – The Straits Times

SINGAPORE - A Singaporean doctorwho is one of the top cell therapy experts in the worldhas been appointed to a World Health Organisation (WHO) expert panel.

Dr Mickey Koh is so sought-after in his field that for the past 15 years, he has been holding two jobs in two different countries.

The 56-year-old shuttles between England and Singapore, spending six weeks at a time in London, where he oversees the haematology department and looks after bone marrow transplant patients at St George's University Hospital, before returning to Singapore for a week and a half to head the cell therapy programme at the Health Sciences Authority.

Cell therapy is a growing field of medicine that uses living cells as treatment for a variety of diseases and conditions. This is an increasingly important therapeutic area and both his employers have agreed to his unusual schedule.

Over in London, Dr Koh is head of the Haematology Department at St George's Hospital and Medical School. In Singapore, he is the programme and medical director of the cell and gene therapy facility at the Health Sciences Authority.

In May, Dr Koh was selected to be on the WHO Expert Advisory Panel on Biological Standardisation.

Individuals on the panel have to be invited by WHO to apply, and are well recognised in their respective scientific fields. Eminent names on the panel include the current president of the Paul-Ehrlich-Institut in Germany, which is the country's federal agency, medical regulatory body and research institution for vaccines and biomedicine.

The WHO panel, which is made up of about 25 members, provides detailed recommendations and guidelines for the manufacturing, licensing and standardisation of biological products, which include blood, monoclonal antibodies, vaccines and, increasingly, cell-based therapeutics.

The recommendations and advice are passed on to the executive board of the World Health Assembly, which is the decision-making body of WHO.

Dr Koh's role had to be endorsed by the British government and was a direct appointment by the director-general of WHO.

His appointment as a panel expert will last for a term of four years.

Speaking to The Straits Times, Dr Koh shared his thoughts about the importance of regulation: "We are well aware that there is a very lucrative worldwide market peddling unproven stem cell treatments, where side effects are often unknown, and such unregulated practice can result in serious harm.

"This is already happening. People are claiming that you can use stem cells to treat things like ageing, and even very serious conditions like strokes, without any evidence."

With many medications now taking the form of biologics - a drug product derived from biological sources such as cells - the next wave of treatment would be the utilisation of these cells for the treatment of a wide range of diseases, Dr Koh said.

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S'porean doctor, a sought-after top expert in cell therapy, appointed to WHO expert panel - The Straits Times

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Oral symptoms of systemic pathology in a 17-year-old female – DentistryIQ

Presentation

A 17-year-old female presented to a dental school clinic with a chief complaint of a sudden, painless swelling of her gingivae (figures 1 and 2). She had previously gone to a local emergency room. There, her condition was dismissed as a lack of oral hygiene, and she was told to go to a dental provider. The patient had social concerns as she was being ridiculed at school for her condition. She was not pregnant and took no medications. The staff periodontist submitted a large tissue sample to a university pathology lab, and then he performed a gingivectomy on the swollen tissues (figure 3).

In two weeks, the patient returned for a follow-up appointment. The tissue had grown back almost to the original levels (figures 4 and 5). Note the intense red color of the maxillary gingivae.

At this follow-up, the biopsy report was available. Here is a quote from that report: The histomorphology when combined with the clinical presentation and positive staining with MPO and high proliferation index is highly suggestive of acute myeloid or promyelocytic leukemia. The patient should be quickly evaluated by hemo-oncology with this in mind.

Top causes of gingival enlargement and treatment options

Mysterious lesions, Lemonheads, extreme oral herpes, and more

An almost-vague radiodense lesion, mysterious mole, and a tongue top 5

The patient was referred to the University of Floridas Childrens Hospital, where she was treated and went into subsequent remission with chemotherapy. With a timely diagnosis and swift treatment, young people typically respond quickly and favorably. Treatment programs may include chemotherapy, radiation, stem-cell transplant, immunotherapy, or bone marrow transplant.

Myeloid leukemia involves the rapid growth of myeloid blood cells that build up in the bone marrow and prevent the normal production and maturation process. Promyelocytic leukemia is a more aggressive form of myeloid leukemia. In young individuals, these conditions are most often associated with several chromosomal abnormalities. Sudden gingival enlargement is not an uncommon symptom.1 It may occur in patients with non-Hodgkins lymphoma.2

Certain medications may initiate gingival hyperplasia. It is common in renal transplant patients who are treated with cyclosporine and a calcium channel blocker.3 Other medications such as carbamazepine, phenytoin, topiramate, and valproic acid are all possible triggering agents.4 Finally, certain immunosuppressants have the potential to trigger gingival hyperplasia.

Editors note:This article first appeared inThrough the Loupesnewsletter, a publication of the Endeavor Business Media Dental Group.Read more articlesandsubscribetoThrough the Loupes.

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Oral symptoms of systemic pathology in a 17-year-old female - DentistryIQ

Recommendation and review posted by Bethany Smith

Cell Culture Media Market: Competitive Approach, Breakdown And Forecast by 2027 – Digital Journal

Market Overview

Thecell culture media marketis expected to cross USD 4.33 billion by 2027 at a CAGR of8.33%.

Market Dynamics

The markets growth is being fueled by a diverse range of cell culture media applications, increased research and development in the pharmaceutical industry, an increase in the prevalence of chronic diseases, and increased expansion and product launches by major players. Over the last few decades, advancements in cell culture technology have accelerated. It is widely regarded as one of the most dependable, robust, and mature technologies for biotherapeutic product development.

The high cost of cell culture media and the risk of contamination, on the other hand, are impeding the markets growth. However, the growing emphasis on regenerative and personalized medicine is likely to spur growth in the global cell culture media market.

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Competitive Dynamics

The notable players are the Merck KGaA (Germany), Bio-Rad Laboratories, Inc. (US), Thermo Fisher Scientific Inc. (US), Lonza (Switzerland), GE Healthcare (US), Becton, Dickinson and Company (US), HiMedia Laboratories (India), Corning Incorporated (US), PromoCell (Germany), Sera Scandia A/S (Denmark), The Sartorius Group (Germany), and Fujifilm Holdings Corporation (Japan).

Segmental Analysis

The global market for cell culture media has been segmented according to product type, application, and end user.

The market has been segmented by product type into classical media, stem cell media, serum-free media, and others.

Further subcategories of stem cell culture media include bone marrow, embryonic stem cells, mesenchymal stem cells, and neural stem cells.

The market is segmented into four application segments: drug discovery and development, cancer research, genetic engineering, and tissue engineering and biochemistry.

The market is segmented by end user into biochemistry and pharmaceutical companies, research laboratories, academic institutions, and pathology laboratories.

Regional Overview

According to region, the global cell culture media market is segmented into the Americas, Europe, Asia-Pacific, and the Middle East & Africa.

The Americas dominated the global cell culture media market. The large share is attributed to the presence of major manufacturers, rising disease prevalence resulting in increased demand for drugs and other medications, technological advancements in the preclinical and clinical segments, growing public awareness, and high disposable income.

Europe ranks second in terms of market size for cell culture media. Factors such as an increase in the biopharmaceutical sector in the European region, increased government initiatives to promote research to find a cure for the growing number of chronic diseases, an increase in the number of pharmaceutical manufacturers, improving economies, a high disposable income per individual, and increased healthcare spending are all contributing to the markets growth in this region. The European market is expected to be driven by expanding R&D activities and a developing biopharmaceutical sector.

Asia-Pacific held the third-largest market share, owing to the presence of numerous research organizations, low manufacturing costs, low labor costs, developing healthcare infrastructure, and increased investment by American and European market giants in Asian countries such as China and India.

The Middle East and Africa, with limited economic development and extremely low income, held the smallest market share in 2019 but is expected to grow due to growing public awareness and demand for improved healthcare facilities in countries, as well as rising disposable income.

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Cell Culture Media Market: Competitive Approach, Breakdown And Forecast by 2027 - Digital Journal

Recommendation and review posted by Bethany Smith

Kite’s CAR T-cell Therapy Tecartus Receives Positive CHMP Opinion in Relapsed or Refractory Acute Lymphoblastic Leukemia (r/r ALL) – Gilead Sciences

Tecartus (Brexucabtagene Autoleucel) First and Only CAR T in Europe to Receive Positive CHMP Opinion to Treat Adults 26+ with r/r ALL

If Approved, it will Address a Significant Unmet Need for a Patient Population with Limited Treatment Options

SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD), today announces that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients 26 years of age and above with relapsed or refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL). If approved, Tecartus will be the first and only Chimeric Antigen Receptor (CAR) T-cell therapy for this population of patients who have limited treatment options. Half of adults with ALL will relapse, and median overall survival (OS) for this group is only approximately eight months with current standard-of-care treatments.

Kites goal is clear: to bring the hope of survival to more patients with cancer around the world through cell therapy, said Christi Shaw, CEO, Kite. Todays CHMP positive opinion in adult ALL brings us a step closer to delivering on the promise that cell therapies have to transform the way cancer is treated.

Following this positive opinion, the European Commission will now review the CHMP opinion; the final decision on the Marketing Authorization is expected in the coming months.

Adults with relapsed or refractory ALL often undergo multiple treatments including chemotherapy, targeted therapy and stem cell transplant, creating a significant burden on a patients quality of life, said Max S. Topp, MD, professor and head of Hematology, University Hospital of Wuerzburg, Germany. If approved, patients in Europe will have a meaningful advancement in treatment. Tecartus has demonstrated durable responses, suggesting the potential for long-term remission and a new approach to care.

Results from the ZUMA-3 international multicenter, single-arm, open-label, registrational Phase 1/2 study of adult patients (18 years old) with relapsed or refractory ALL, demonstrated that 71% of the evaluable patients (n=55) achieved complete remission (CR) or CR with incomplete hematological recovery (CRi) with a median follow-up of 26.8 months. In an extended data set of all patients dosed with the pivotal dose (n=78) the median overall survival for all patients was more than two years (25.4 months) and almost four years (47 months) for responders (patients who achieved CR or CRi). Among efficacy-evaluable patients, median duration of remission (DOR) was 18.6 months. Among the patients treated with Tecartus at the target dose (n=100), Grade 3 or higher cytokine release syndrome (CRS) and neurologic events occurred in 25% and 32% of patients, respectively, and were generally well-managed.

About ZUMA-3

ZUMA-3 is an ongoing international multicenter (US, Canada, EU), single arm, open label, registrational Phase 1/2 study of Tecartus in adult patients (18 years old) with ALL whose disease is refractory to or has relapsed following standard systemic therapy or hematopoietic stem cell transplantation. The primary endpoint is the rate of overall complete remission or complete remission with incomplete hematological recovery by central assessment. Duration of remission and relapse-free survival, overall survival, minimal residual disease (MRD) negativity rate, and allo-SCT rate were assessed as secondary endpoints.

About Acute Lymphoblastic Leukemia

ALL is an aggressive type of blood cancer that develops when abnormal white blood cells accumulate in the bone marrow until there isnt any room left for blood cells to form. In some cases, these abnormal cells invade healthy organs and can also involve the lymph nodes, spleen, liver, central nervous system and other organs. The most common form is B cell precursor ALL. Globally, approximately 64,000 people are diagnosed with ALL each year, including around 3,300 people in Europe.

About Tecartus

Please see full FDA Prescribing Information, including BOXED WARNING and Medication Guide.

Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred following treatment with Tecartus. In ZUMA-2, CRS occurred in 91% (75/82) of patients receiving Tecartus, including Grade 3 CRS in 18% of patients. Among the patients who died after receiving Tecartus, one had a fatal CRS event. The median time to onset of CRS was three days (range: 1 to 13 days) and the median duration of CRS was ten days (range: 1 to 50 days). Among patients with CRS, the key manifestations (>10%) were similar in MCL and ALL and included fever (93%), hypotension (62%), tachycardia (59%), chills (32%), hypoxia (31%), headache (21%), fatigue (20%), and nausea (13%). Serious events associated with CRS included hypotension, fever, hypoxia, tachycardia, and dyspnea.

Ensure that a minimum of two doses of tocilizumab are available for each patient prior to infusion of Tecartus. Following infusion, monitor patients for signs and symptoms of CRS daily for at least seven days for patients with MCL and at least 14 days for patients with ALL at the certified healthcare facility, and for four weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

Neurologic Events, including those that were fatal or life-threatening, occurred following treatment with Tecartus. Neurologic events occurred in 81% (66/82) of patients with MCL, including Grade 3 in 37% of patients. The median time to onset for neurologic events was six days (range: 1 to 32 days) with a median duration of 21 days (range: 2 to 454 days) in patients with MCL. Neurologic events occurred in 87% (68/78) of patients with ALL, including Grade 3 in 35% of patients. The median time to onset for neurologic events was seven days (range: 1 to 51 days) with a median duration of 15 days (range: 1 to 397 days) in patients with ALL. For patients with MCL, 54 (66%) patients experienced CRS before the onset of neurological events. Five (6%) patients did not experience CRS with neurologic events and eight patients (10%) developed neurological events after the resolution of CRS. Neurologic events resolved for 119 out of 134 (89%) patients treated with Tecartus. Nine patients (three patients with MCL and six patients with ALL) had ongoing neurologic events at the time of death. For patients with ALL, neurologic events occurred before, during, and after CRS in 4 (5%), 57 (73%), and 8 (10%) of patients; respectively. Three patients (4%) had neurologic events without CRS. The onset of neurologic events can be concurrent with CRS, following resolution of CRS or in the absence of CRS.

The most common neurologic events (>10%) were similar in MCL and ALL and included encephalopathy (57%), headache (37%), tremor (34%), confusional state (26%), aphasia (23%), delirium (17%), dizziness (15%), anxiety (14%), and agitation (12%). Serious events including encephalopathy, aphasia, confusional state, and seizures occurred after treatment with Tecartus.

Monitor patients daily for at least seven days for patients with MCL and at least 14 days for patients with ALL at the certified healthcare facility and for four weeks following infusion for signs and symptoms of neurologic toxicities and treat promptly.

REMS Program: Because of the risk of CRS and neurologic toxicities, Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program which requires that:

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO) or residual gentamicin in Tecartus.

Severe Infections: Severe or life-threatening infections occurred in patients after Tecartus infusion. Infections (all grades) occurred in 56% (46/82) of patients with MCL and 44% (34/78) of patients with ALL. Grade 3 or higher infections, including bacterial, viral, and fungal infections, occurred in 30% of patients with ALL and MCL. Tecartus should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after Tecartus infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 6% of patients with MCL and 35% of patients with ALL after Tecartus infusion and may be concurrent with CRS. The febrile neutropenia in 27 (35%) of patients with ALL includes events of febrile neutropenia (11 (14%)) plus the concurrent events of fever and neutropenia (16 (21%)). In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, life-threatening and fatal opportunistic infections have been reported. The possibility of rare infectious etiologies (e.g., fungal and viral infections such as HHV-6 and progressive multifocal leukoencephalopathy) should be considered in patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Tecartus infusion. In patients with MCL, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 55% (45/82) of patients and included thrombocytopenia (38%), neutropenia (37%), and anemia (17%). In patients with ALL who were responders to Tecartus treatment, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 20% (7/35) of the patients and included neutropenia (12%) and thrombocytopenia (12%); Grade 3 or higher cytopenias not resolved by Day 60 following Tecartus infusion occurred in 11% (4/35) of the patients and included neutropenia (9%) and thrombocytopenia (6%). Monitor blood counts after Tecartus infusion.

Hypogammaglobulinemia: B cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with Tecartus. Hypogammaglobulinemia was reported in 16% (13/82) of patients with MCL and 9% (7/78) of patients with ALL. Monitor immunoglobulin levels after treatment with Tecartus and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement.

The safety of immunization with live viral vaccines during or following Tecartus treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least six weeks prior to the start of lymphodepleting chemotherapy, during Tecartus treatment, and until immune recovery following treatment with Tecartus.

Secondary Malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

Effects on Ability to Drive and Use Machines: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Tecartus infusion. Advise patients to refrain from driving and engaging in hazardous activities, such as operating heavy or potentially dangerous machinery, during this period.

Adverse Reactions: The most common non-laboratory adverse reactions ( 20%) were fever, cytokine release syndrome, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting. The most common serious adverse reactions ( 2%) were cytokine release syndrome, febrile neutropenia, hypotension, encephalopathy, fever, infection with pathogen unspecified, hypoxia, tachycardia, bacterial infections, respiratory failure, seizure, diarrhea, dyspnea, fungal infections, viral infections, coagulopathy, delirium, fatigue, hemophagocytic lymphohistiocytosis, musculoskeletal pain, edema, and paraparesis.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kites singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit http://www.kitepharma.com. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Tecartus; the risk that physicians may not see the benefits of prescribing Tecartus for the treatment of blood cancers; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gileads Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements.

U.S. Prescribing Information for Tecartus including BOXED WARNING, is available at http://www.kitepharma.com and http://www.gilead.com .

Kite, the Kite logo, Tecartus and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies .

View source version on businesswire.com: https://www.businesswire.com/news/home/20220722005258/en/

Jacquie Ross, Investorsinvestor_relations@gilead.com

Anna Padula, Mediaapadula@kitepharma.com

Source: Gilead Sciences, Inc.

Read more from the original source:
Kite's CAR T-cell Therapy Tecartus Receives Positive CHMP Opinion in Relapsed or Refractory Acute Lymphoblastic Leukemia (r/r ALL) - Gilead Sciences

Recommendation and review posted by Bethany Smith

No Stone Unturned: Seattle Children’s High-Risk Leukemia Experts Specialize in the Toughest Cases – On the Pulse – On the Pulse – On the Pulse

Josh, Harper and Meagan in June 2022

Two years ago, Meagan stood in a hospital room at Seattle Childrens cradling her 1-year-old daughter, Harper, against her chest. Her fianc, Josh, huddled close to them and kissed the thinning hair on top of their babys head.

A feeding tube was routed through Harpers nose and her eyes were brimming with tears. Exhausted, she snuggled into her moms arms as a photographer took their picture.

Meagan and Josh feared those would be the last photos taken of their baby girl.

Six months before, Harper became seriously ill. After multiple visits to their pediatrician in Yakima, Meagan took her to an emergency room where blood tests revealed Harper had leukemia.

It was shocking, Meagan says. Thirty minutes later we were on an emergency flight to Seattle Childrens.

The family didnt return home for nearly two years.

The type of leukemia Harper had acute lymphoblastic leukemia (ALL) is typically harder to treat and has lower survival rates when it occurs in infants who are less than a year old.

Harpers case was exceptionally challenging. She didnt respond to standard chemotherapy, even after providers added a medication designed to sensitize her leukemia to the treatment.

Her care team, which included Seattle Childrens High-Risk Leukemia Program, believed a stem cell transplant would give Harper the best chance of surviving, but they had to eliminate the majority of her leukemia cells first.

Drs. Kasey Leger and Brittany Lee, Harpers primary oncologists, started her on a novel immunotherapy medication, called blinatumomab, which effectively destroyed many of her ALL cells.

Unfortunately, two weeks later, the team discovered some of Harpers ALL cells had morphed into a different blood cancer acute myeloid leukemia (AML). This rare occurrence, called lineage switch, occurs in less than 5% of infant ALL cases.

It was a roller coaster, Josh says. She didnt do anything they expected her to do. It felt like every day we had to come up with a new plan.

Drs. Leger and Lee gave Harper a different kind of chemotherapy that destroyed the new AML cells. Still, some of her ALL cells remained, so the team gave Harper blinatumomab again which finally suppressed her cancer enough for her to have a stem cell transplant just before her first birthday.

Harper and her mom, Meagan, celebrating Harpers first birthday shortly after her stem cell transplant

The team had done everything they could to get Harper healthy enough for a stem cell transplant, hopeful it would be the treatment that finally cured her. Tragically, Harpers leukemia was back less than a month later.

When leukemia comes back so soon after transplant, patients have very few treatment options, if any, says Dr. Corinne Summers, Harpers stem cell transplant specialist. Many patients will not survive long term.

Harpers parents were terrified they were going to lose her.

Her bone marrow was packed with leukemia, Josh remembers. You could tell the life was slipping out of her and she just looked like it was going to be the end.

After Harpers stem cell transplant failed, the family met with end-of-life specialists and scheduled a special photo session to create memories that they would carry forward

They struggled to decide if they should continue treatment.

How do you know when enough is enough? Meagan says. When do you say, We cant do this to her anymore? Harper couldnt tell us how she was feeling, so it was all our decision.

Meagan and Josh worked closely with the care team to decide what to do next.

Those conversations were emotional for all of us, says Dr. Lee. Thankfully, we had a close, trusting relationship with their family and were able to give recommendations that reflected what they wanted for their daughter and what they felt was most important.

After much consideration, Meagan and Josh decided Harper was strong enough to continue treatment.

Drs. Leger and Lee filed a compassionate use request with the Food and Drug Administration to give Harper an investigational chemotherapy drug called venetoclax. Unfortunately, the treatment didnt work.

Collaborating with the family, the team decided to try giving Harper blinatumomab one more time. There was no evidence suggesting the medication would work so soon after a bone marrow transplant and with such a high burden of leukemia, but within a week it eliminated 98% of Harpers cancer cells.

Family is a critical piece of the team, Dr. Leger says. And Harper is fortunate to have amazing parents who were at her bedside 24/7 and had a beautiful way of advocating for her. They challenged us to leave no stone unturned and partnered with us throughout her treatment to keep figuring out a way forward.

With Harpers leukemia under control, the team searched for a way to wipe out any remaining cancer cells and keep her disease from coming back. Doctors in Childrens Cancer and Blood Disorders Center lead national research groups such as the Childrens Oncology Group, so they have access to trials around the world. However, Harpers care team found the best treatment for her was at Seattle Childrens Hospital, in partnership with Seattle Childrens Therapeutics.

Harpers T-cells were removed through a process called apheresis before they were reprogrammed to target her cancer cells and infused back into her blood

Harper was enrolled in one of Childrens T-cell immunotherapy clinical trials. The treatment involves re-programming a patients T cells (a type of white blood cell) to target and destroy their cancer cells.

After her T-cell therapy, Harper was finally in remission.

Meagan cried with relief when she found out. Harper would not be here right now if it wasnt for everybody at Seattle Childrens, she says. From day one, theyve been comforting and compassionate. They bend over backwards to keep families involved and helped us fight for our child.

To keep her in remission, Harper was given six antigen-presenting cell boosters, which kept her reprogrammed T cells circulating through her blood longer. She received the last booster earlier this year and is still in remission today.

Harper had a very unique disease in that her leukemia manifested as both ALL and AML, says Dr. Leger. Thankfully, we have team members with deep expertise in each of those diseases. Having internationally recognized chemotherapy, transplant and immunotherapy specialists on our team allowed us to be creative with her care when she needed to go beyond the standard pathways.

Today, Harper is a joyful, boisterous 3-year-old who loves experimenting with musical toys and splashing around in her bath or kiddie pool. One of her favorite things to do is grab Meagan by the hair and squish their faces together.

Because of the treatments Harper received at such a young age and the extended time she spent in the hospital, Harper is behind on some developmental milestones like speaking and walking. Still, Meagan and Josh say shes catching up.

Shes starting to bloom and take off and its so nice to see, Meagan says. At the same time, we cant get too comfortable. We know how relentless her disease is and that it could come back one day.

Harper plays in a pool, one of her favorite activities, in June 2022

Harpers family encourages community members to support cancer research at Childrens so that new treatments can be developed for Harper and other kids like her.

Without donors, Harper probably wouldnt be alive right now, Josh says. The treatments she had were developed in just the last few years. If people dont step up and donate, those programs arent there. Those drugs arent invented. Cancer treatment has come a really long way and thats because of donors stepping up to make that happen.

Learn more about Seattle Childrens High-Risk Leukemia Program and Cancer and Blood Disorders Center.

Related

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No Stone Unturned: Seattle Children's High-Risk Leukemia Experts Specialize in the Toughest Cases - On the Pulse - On the Pulse - On the Pulse

Recommendation and review posted by Bethany Smith

Stem Cell Therapy Market Size, Scope, Growth Opportunities, Trends by Manufacturers And Forecast to 2029 This Is Ardee – This Is Ardee

New Jersey, United States TheStem Cell TherapyMarket research guides new entrants to obtain precise market data and communicates with customers to know their requirements and preferences. It spots outright business opportunities and helps to bring new products into the market. It identifies opportunities in the marketplace. It aims at doing modifications in the business to make business procedures smooth and make business forward. It helps business players to make sound decision making. Stem Cell Therapy market report helps to reduce business risks and provides ways to deal with upcoming challenges. Market information provided here helps new entrants to take informed decisions making. It emphasizes on major regions of the globe such as Europe, North America, Asia Pacific, Middle East, Africa, and Latin America along with their market size.

Such unique Stem Cell Therapy Market research report offers some extensive strategic plans that help the players to deal with the current market situation and make your position. It helps in strengthening your business position. It offers better understanding of the market and keep perspective to aid one remain ahead in this competitive market. Organizations can gauze and compare their presentation with others in the market on the basis of this prompt market report. This market report offers a clarified picture of the varying market tactics and thereby helps the business organizations gain bigger profits. You get a clear idea about the product launches, trade regulations and expansion of the market place through this market report.

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Osiris Therapeutics Medipost Co. Ltd., Anterogen Co. Ltd., Pharmicell Co. Ltd., HolostemTerapieAvanzateSrl, JCR Pharmaceuticals Co. Ltd., Nuvasive RTI Surgical Allosource

Stem Cell TherapyMarket report consists of important data about the entire market environment of products or services offered by different industry players. It enables industries to know the market scenario of a particular product or service including demand, supply, market structure, pricing structure, and trend analysis. It is of great assistance in the product market development. It further depicts essential data regarding customers, products, competition, and market growth factors. Stem Cell Therapy market research benefits greatly to make the proper decision. Future trends are also revealed for particular products or services to help business players in making the right investment and launching products into the market.

Stem Cell TherapyMarket Segmentation:

Stem Cell Therapy Market, By Cell Source

Adipose Tissue-Derived Mesenchymal Stem Cells Bone Marrow-Derived Mesenchymal Stem Cells Cord Blood/Embryonic Stem Cells Other Cell Sources

Stem Cell Therapy Market, By Therapeutic Application

Musculoskeletal Disorders Wounds and Injuries Cardiovascular Diseases Surgeries Gastrointestinal Diseases Other Applications

Stem Cell Therapy Market, By Type

Allogeneic Stem Cell Therapy Autologous Stem Cell Therapy

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For Prepare TOC Our Analyst deep Researched the Following Things:

Report Overview:It includes major players of the Stem Cell Therapy market covered in the research study, research scope, market segments by type, market segments by application, years considered for the research study, and objectives of the report.

Global Growth Trends:This section focuses on industry trends where market drivers and top market trends are shed light upon. It also provides growth rates of key producers operating in the Stem Cell Therapy market. Furthermore, it offers production and capacity analysis where marketing pricing trends, capacity, production, and production value of the Stem Cell Therapy market are discussed.

Market Share by Manufacturers:Here, the report provides details about revenue by manufacturers, production and capacity by manufacturers, price by manufacturers, expansion plans, mergers and acquisitions, and products, market entry dates, distribution, and market areas of key manufacturers.

Market Size by Type:This section concentrates on product type segments where production value market share, price, and production market share by product type are discussed.

Market Size by Application:Besides an overview of the Stem Cell Therapy market by application, it gives a study on the consumption in the Stem Cell Therapy market by application.

Production by Region:Here, the production value growth rate, production growth rate, import and export, and key players of each regional market are provided.

Consumption by Region:This section provides information on the consumption in each regional market studied in the report. The consumption is discussed on the basis of country, application, and product type.

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Market Forecast by Production:The production and production value forecasts included in this section are for the Stem Cell Therapy market as well as for key regional markets.

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Stem Cell Therapy Market Size, Scope, Growth Opportunities, Trends by Manufacturers And Forecast to 2029 This Is Ardee - This Is Ardee

Recommendation and review posted by Bethany Smith

The Worldwide Genetic Testing Industry is Expected to Reach $26 Billion by 2027 – ResearchAndMarkets.com – Galveston County Daily News

Country

United States of AmericaUS Virgin IslandsUnited States Minor Outlying IslandsCanadaMexico, United Mexican StatesBahamas, Commonwealth of theCuba, Republic ofDominican RepublicHaiti, Republic ofJamaicaAfghanistanAlbania, People's Socialist Republic ofAlgeria, People's Democratic Republic ofAmerican SamoaAndorra, Principality ofAngola, Republic ofAnguillaAntarctica (the territory South of 60 deg S)Antigua and BarbudaArgentina, Argentine RepublicArmeniaArubaAustralia, Commonwealth ofAustria, Republic ofAzerbaijan, Republic ofBahrain, Kingdom ofBangladesh, People's Republic ofBarbadosBelarusBelgium, Kingdom ofBelizeBenin, People's Republic ofBermudaBhutan, Kingdom ofBolivia, Republic ofBosnia and HerzegovinaBotswana, Republic ofBouvet Island (Bouvetoya)Brazil, Federative Republic ofBritish Indian Ocean Territory (Chagos Archipelago)British Virgin IslandsBrunei DarussalamBulgaria, People's Republic ofBurkina FasoBurundi, Republic ofCambodia, Kingdom ofCameroon, United Republic ofCape Verde, Republic ofCayman IslandsCentral African RepublicChad, Republic ofChile, Republic ofChina, People's Republic ofChristmas IslandCocos (Keeling) IslandsColombia, Republic ofComoros, Union of theCongo, Democratic Republic ofCongo, People's Republic ofCook IslandsCosta Rica, Republic ofCote D'Ivoire, Ivory Coast, Republic of theCyprus, Republic ofCzech RepublicDenmark, Kingdom ofDjibouti, Republic ofDominica, Commonwealth ofEcuador, Republic ofEgypt, Arab Republic ofEl Salvador, Republic ofEquatorial Guinea, Republic ofEritreaEstoniaEthiopiaFaeroe IslandsFalkland Islands (Malvinas)Fiji, Republic of the Fiji IslandsFinland, Republic ofFrance, French RepublicFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabon, Gabonese RepublicGambia, Republic of theGeorgiaGermanyGhana, Republic ofGibraltarGreece, Hellenic RepublicGreenlandGrenadaGuadaloupeGuamGuatemala, Republic ofGuinea, RevolutionaryPeople's Rep'c ofGuinea-Bissau, Republic ofGuyana, Republic ofHeard and McDonald IslandsHoly See (Vatican City State)Honduras, Republic ofHong Kong, Special Administrative Region of ChinaHrvatska (Croatia)Hungary, Hungarian People's RepublicIceland, Republic ofIndia, Republic ofIndonesia, Republic ofIran, Islamic Republic ofIraq, Republic ofIrelandIsrael, State ofItaly, Italian RepublicJapanJordan, Hashemite Kingdom ofKazakhstan, Republic ofKenya, Republic ofKiribati, Republic ofKorea, Democratic People's Republic ofKorea, Republic ofKuwait, State ofKyrgyz RepublicLao People's Democratic RepublicLatviaLebanon, Lebanese RepublicLesotho, Kingdom ofLiberia, Republic ofLibyan Arab JamahiriyaLiechtenstein, Principality ofLithuaniaLuxembourg, Grand Duchy ofMacao, Special Administrative Region of ChinaMacedonia, the former Yugoslav Republic ofMadagascar, Republic ofMalawi, Republic ofMalaysiaMaldives, Republic ofMali, Republic ofMalta, Republic ofMarshall IslandsMartiniqueMauritania, Islamic Republic ofMauritiusMayotteMicronesia, Federated States ofMoldova, Republic ofMonaco, Principality ofMongolia, Mongolian People's RepublicMontserratMorocco, Kingdom ofMozambique, People's Republic ofMyanmarNamibiaNauru, Republic ofNepal, Kingdom ofNetherlands AntillesNetherlands, Kingdom of theNew CaledoniaNew ZealandNicaragua, Republic ofNiger, Republic of theNigeria, Federal Republic ofNiue, Republic ofNorfolk IslandNorthern Mariana IslandsNorway, Kingdom ofOman, Sultanate ofPakistan, Islamic Republic ofPalauPalestinian Territory, OccupiedPanama, Republic ofPapua New GuineaParaguay, Republic ofPeru, Republic ofPhilippines, Republic of thePitcairn IslandPoland, Polish People's RepublicPortugal, Portuguese RepublicPuerto RicoQatar, State ofReunionRomania, Socialist Republic ofRussian FederationRwanda, Rwandese RepublicSamoa, Independent State ofSan Marino, Republic ofSao Tome and Principe, Democratic Republic ofSaudi Arabia, Kingdom ofSenegal, Republic ofSerbia and MontenegroSeychelles, Republic ofSierra Leone, Republic ofSingapore, Republic ofSlovakia (Slovak Republic)SloveniaSolomon IslandsSomalia, Somali RepublicSouth Africa, Republic ofSouth Georgia and the South Sandwich IslandsSpain, Spanish StateSri Lanka, Democratic Socialist Republic ofSt. HelenaSt. Kitts and NevisSt. LuciaSt. Pierre and MiquelonSt. Vincent and the GrenadinesSudan, Democratic Republic of theSuriname, Republic ofSvalbard & Jan Mayen IslandsSwaziland, Kingdom ofSweden, Kingdom ofSwitzerland, Swiss ConfederationSyrian Arab RepublicTaiwan, Province of ChinaTajikistanTanzania, United Republic ofThailand, Kingdom ofTimor-Leste, Democratic Republic ofTogo, Togolese RepublicTokelau (Tokelau Islands)Tonga, Kingdom ofTrinidad and Tobago, Republic ofTunisia, Republic ofTurkey, Republic ofTurkmenistanTurks and Caicos IslandsTuvaluUganda, Republic ofUkraineUnited Arab EmiratesUnited Kingdom of Great Britain & N. IrelandUruguay, Eastern Republic ofUzbekistanVanuatuVenezuela, Bolivarian Republic ofViet Nam, Socialist Republic ofWallis and Futuna IslandsWestern SaharaYemenZambia, Republic ofZimbabwe

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The Worldwide Genetic Testing Industry is Expected to Reach $26 Billion by 2027 - ResearchAndMarkets.com - Galveston County Daily News

Recommendation and review posted by Bethany Smith

Genetic testing may benefit patients with depression – VAntage Point – VAntage Point Blog

Pharmacogenomic or genetic testing can help providers avoid prescribing antidepressant medications that may have undesirable outcomes, found a VA study. Pharmacogenomics is the study of how genes affect the bodys response to drugs.

Patients who underwent genetic testing had more positive outcomes, compared with patients in usual care. Over 24 weeks of treatment, the group with genetic testing had in a drop in depression symptomswith a peak effect at 12 weeks. Each patient in the study had major depressive disorder. Symptoms of that health condition include insomnia, loss of appetite, feelings of sadness and depression, and thoughts of dying by suicide.

Dr. David Oslin, director of the VA VISN 4 Mental Illness, Research, Education, and Clinical Center, located in Philadelphia and Pittsburgh, led the study. He thinks the results will encourage providers to consider using pharmacogenomic testing, with patient consent, to help drive treatment decisions.

From a VA policy perspective, I dont think that we would say the study is robust enough that we recommend testing everybody, says Oslin. But I think the results favoring a positive effect on treatment, although small, will encourage providers to test patients and get this genetic information. Future research should explore if there are subgroups of patients who would benefit more from testing.

Focus on metabolizing drugs

In recent years, pharmacogenomic testing has received greater attention as a tool to personalize medication selection and is often used to treat patients with health conditions such as cancer and heart disease. Many in the medical community hope the testing can also be helpful in treating people with major depressive disorder. Research has been limited, however, on demonstrating improved clinical outcomes.

The genes we tested dont actually relate to depression, Oslin says. They relate to how a person metabolizes the drugs once theyre in the body. Some of these genes will cause the medications to metabolize much faster than normal. Others will cause the drugs to metabolize much slower than normal, which means youll end up with a lot of medication in your body.

The patients enrolled in the study were initiating or switching treatment with an antidepressant drug. The study included nearly 2,000 patients from 22 VA medical centers who were randomized evenly, with half receiving pharmacogenomic testing and the other half getting usual care. Oslin and his colleagues aimed to learn if genetic testing helped patients receive fewer medications with predicted drug-gene interactions and if that produced better outcomes.

A drug-gene interaction isan association between a medication and a genetic variant that may affect a patients response to drug treatment. Having that information helps the provider select the appropriate dosage for a specific patient.

The crux of the study

The study found a marked shift in prescribing away from medications with significant drug-gene interactions or moderate drug-gene interactions. Overall, 59% of the patients in the genetic testing group received a medication with no predicted drug-gene interaction, compared with 26% in the control group. The researchers defined that difference as statistically significant and clinically meaningful.

Oslin says he went into the study thinking the research team would not see such a dramatic effect in predicted drug-gene interactions. He was somewhat surprised by the result. There was essentially a major shift in avoiding medicines that had a predicted drug-gene interaction, he says.

Its important to realize that the test is not telling you whether the patient is going to respond to the treatment or not, he adds. Its telling you something about how the patient metabolizes the medication. So, its not telling me that this is a good medicine for the patient. Its telling me not to prescribe this medicine, or perhaps to adjust the dosing, because the patient doesnt metabolize it well.

More information

Clickhereto read the rest of the story.

Clickhereto learn more about VA research.

Link:
Genetic testing may benefit patients with depression - VAntage Point - VAntage Point Blog

Recommendation and review posted by Bethany Smith

What Does it Mean to be High Risk for Breast Cancer? – Integris

Each year, more than a quarter million women will be diagnosed with breast cancer, making it the second most common type of cancer in women behind only skin cancer. In fact, breast cancer diagnosesannually account for about 30 percent of new female cancers, according to the American Cancer Society.

Based on gender alone, women have a one in eight (13 percent) chance of developing breast cancer during their life. Due to various controllable factors, such as weight, activity level, diet, alcohol consumption and lack of screening, mammograms these percentages increase.

In certain cases, some women are categorized as being at high risk of developing breast cancer due to uncontrollable risk factors. To learn more about what high risk breast cancer means, we sought out information from Nicole Sharp Cottrell, M.D., a board-certified and fellowship-trained breast surgical oncologist at INTEGRIS Breast Surgery.

Genetics and family historyare the two main factors that place a woman in the high risk breast cancer category. These women have at least a 20 percent chance of developing breast cancer compared to 13 percent of all other women in the average risk category.

In addition to these factors, Dr. Sharp also noted how gender and age can increase your risk of breast cancer. There are additional factors that can also increase your risk of breast cancer, such as obesity, exposure to hormones and activity level.

Certain genetic mutations can increase your breast cancer risk by more than 80 percent.

Everyone has BRCA1 and BRCA2 genes that help with cellular repair and inhibit tumor growth. In some people, BRCA 1/2 genes, which encode tumor suppression proteins, have mutations resulting in increased risk of cancer. Only about 5-10% of breast cancers are from a known genetic mutation, with BRCA1/2 mutations being the most common mutation associated with breast and ovarian cancer syndromes. In addition, men with BRCA mutations are at increased risk for prostate cancer. Additional risks include pancreatic cancer, melanoma and potentially serious uterine cancers.

While BRCA genes are the most common genetic risk factor for breast cancer, other genes can also lead to a diagnosis. These genes currently include:

Its important to know the gene mutations you are being tested for, because there may be limited genetics testing done for just BRCA1/2 versus a broader genetics panel testing done, Dr. Sharp says. Genetics research is continuously evolving to identify additional mutations and their associated cancers. People with a known family history of a gene mutation or those with family histories suspicious of mutations, should seek evaluation for genetic testing for themselves.

As with other types of cancers, your risk of developing breast cancer increases if an immediate family member, also called first-degree relative (mother, sister or daughter), previously had breast cancer. The risk is even higher if multiple family members had breast cancer, especially those who develop cancerous cells before menopause or if both breasts were affected.

Although family history is a strong indicator of potential future breast cancer, it is by no means a guarantee youll end up having breast cancer. For example, nearly 90 percent of breast cancer cases have no family history.

Aside from genetics and family history, the following factors may also put you at high risk:

Previous breast cancer diagnosis: Women who had a previous bout with breast cancer are three to four times more likely to have a recurrent diagnosis. This includes ductal carcinoma in situ (DCIS), which is a type of cancer that affects the milk ducts but has not spread outside of the ducts. DCIS is a stage 0 breast cancer.

History of breast lesions: Women can develop a condition called lobular carcinoma in situ (LCIS), which describes abnormal tissue growth in the lobules (the sacs responsible for producing breast milk). Although LCIS isnt breast cancer, women with these lesions are seven to 11 times more likely to develop breast cancer.

Radiation exposure: Radiation therapy can treat many conditions, from cancer to tuberculosis. Women who are exposed to certain types of radiation are at a higher risk of developing breast cancer. Younger women with a history of radiation exposure are more at risk than older women.

For some women, a family or personal history of having breast cancer makes it easy to determine future risk. For others, it isnt as obvious.

To help estimate risk, there are several tools you can use to determine the likelihood of developing breast cancer in the future.

The most common breast cancer risk assessment tool uses the Gail Model, a statistical analysis model created in 1989 by Mitchell Gail, MD, pHd. The Gail Model calculates the likelihood of developing breast cancer within the next five years.

The tool uses the following factors to determine risk:

Once calculated, women are considered high risk if their five-year risk is greater than 1.67 percent. Its important to note the model is made for women who have no history of breast cancer, LCIS or known genetic mutation.

This calculator uses the Tyrer-Cuzick model to project the risk of breast cancer within the next 10 years.

The tool uses the following factors to determine risk:

The results fall under one of three categories: average risk (less than 15 percent), immediate risk (15 to 19 percent) and high risk (more than 20 percent).

The BOADICEA model, which was developed in 2002, is used primarily to assess future breast cancer risk in women who have a genetic mutation. While BRCA1 and BRCA2 are the most common mutations, the tool can also predict other genes such as PALB2, ATM, CHEK2, BARD1, RAD51C and RAD51D.

The tool uses the following factors to determine risk:

People identified as being high-risk for breast cancer, typically defined as a greater than 20 percent lifetime risk of breast cancer, should be offered counseling on risk-reducing options and offered high-risk breast cancer screening, Dr. Sharp says. While this may be done through a primary care provider or gynecologist, INTEGRIS offers high-risk breast counseling and surveillance through our INTEGRIS Breast Surgery Clinic.

Breast self-awareness is encouraged, including monthly self-exams, Dr. Sharp says. Any concerns should prompt a patient to reach out to their provider immediately even if they arent due for an exam or imaging for clinical evaluation.

Depending on your specific risk factors, your doctor may recommend the following:

As Dr. Sharp points out, there is no such thing as preventative treatment.

Instead, we discuss options for risk-reduction treatment as there is always the chance that breast cancer can occur or even recur, she says. In addition to high-risk surveillance, we offer patients options for risk-reduction for breast cancer through lifestyle changes, medications, and consideration of surgery.

For women who have a family history of breast cancer or are at a high risk based on results from the assessment tool, your doctor may recommend meeting with a genetic counselor or a geneticist to determine if you have a mutation to the BRCA gene or another genetic mutation.

Genetic testing for breast cancer is done by analyzing saliva or blood samples for any genetic mutations. In general, you will either test positive or negative for a genetic mutation, although you may have a gene change that isnt covered by the genetic test. In some cases, you may receive an inconclusive test or the test may discover a gene variant of uncertain significance, also known medically as a VUS. A VUS means there is a change in your genetic makeup, but its unclear what effect it will have.

Two medications, tamoxifen and raloxifene, can help lower breast cancer risk by blocking estrogen in breast tissue. Raloxifene is typically only used for older women who have experienced menopause. Studies have shown raloxifene can lower your risk of future breast cancer by nearly 50 percent.

There are also drugs called aromatase inhibitors to reduce the risk of breast cancer. These drugs, sold as generic anastrozole or exemestane dont stop estrogen production, rather they lower levels by inhibiting the production of aromatase, an enzyme found in fat tissue. As a result, aromatase cant change other hormones, such as androgen, into estrogen.

While these medications are sometimes called chemoprevention, they are not considered chemotherapy and do not have traditional chemotherapy-associated side effects, Dr. Sharp says. The patients menopausal status and the side effect profile of each drug impact recommendations for which drug is best for specific patients. These medications are a single oral pill that are taken for 5 years for risk-reduction.

In those patients with dense breasts, we often have improved breast exams and breast imaging studies while they take risk-reducing medications, as the density of the breasts is often decreased. There can be significant side effects associated with these medications, so they are only prescribed to patients at substantial increased risk of breast cancer where the benefits outweigh the risks.

Some women may be interested in risk-reducing surgery with removal of both breasts (bilateral mastectomy). Dr. Sharp says there is evidence to support this in patients at the very highest risk of breast cancer, like those with BRCA 1/2 mutations. However, for most patients, there is no improvement in overall survival after bilateral mastectomy.

Bilateral mastectomy is considered risk-reducing and not risk-eliminating, as breast cancer can still reoccur on the chest wall, in the lymph nodes or distantly, she notes.

Patients may be interested in breast reconstruction. Breast reconstruction may be considered in a delayed fashion at a later operation or in an immediate fashion at the time of their mastectomy, if they are an appropriate candidate after meeting with a plastics and reconstruction team.

Its important to note that even after bilateral mastectomy, ongoing screening with clinical exams is recommended but surveillance breast imaging is no longer indicated. If women are at increased risk of breast and ovarian cancer syndromes, like BRCA 1/2, then a referral to gynecology for surveillance and discussion of risk-reduction with bilateral salpingo-oophorectomy is recommended.

Because medications and surgery come with side effects, a less invasive option includes an annual mammograms consideration of the addition of supplemental breast screening with breast MRI.

Women who fall in the high-risk category should receive a comprehensive clinical breast exam, including both breasts and lymph node basins, every six to 12 months, according to Dr. Sharp. The exact age of when to begin screenings may be determined by the presence of a gene mutation or considered as early as 10 years before the earliest affected family member. For instance, patients with a known high-risk BRCA 1/2 mutation typically begin annual MRI as early as age 25, followed by alternating mammogram with tomosynthesis and MRI every 6 months at age 30.

Annual mammograms should be performed with tomosynthesis (3D mammography), she says. Patients should also be offered options for supplemental breast screening imaging like breast MRIs annually. We typically space out our annual mammograms and MRIs so that you receive an imaging study every six months.

Breast cancer screening doesnt prevent breast cancer, but it allows doctors to find and treat the cancer at an early stage earlier treatment leads to more effective results.

To schedule your mammogram, call 1-855-MY-MAMMO (1-855-696-2666) or talk with your doctor about how often you should receive a mammogram.

Dr. Sharp encourages cancer genetic testing in patients with a family history suspicious for breast and ovarian cancer syndromes. Any patients with a family history of ovarian cancer should be considered for genetic testing. Patients with multiple generations of breast cancer, early onset breast cancer or triple negative breast cancer should also be considered for genetic testing. Additionally, patients with family history of pancreatic cancer or metastatic or advanced stage prostate cancer are also often offered genetic testing.

The American Society of Breast Surgeons (ASBrS) recommends consideration of genetics testing in all breast cancer patients, she says. We work with insurance to obtain coverage whenever possible. If genetics testing is desired and not covered by insurance, we do have options for significantly discounted testing.

For women who are at a high risk for breast cancer, INTEGRIS Breast Health Serviceshas a High Risk and Genetics Clinicto determine the best course of treatment to reduce your risk of developing breast cancer in the future.

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What Does it Mean to be High Risk for Breast Cancer? - Integris

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Boy has rare genetic disease, life expectancy is five to 10 years – Insider

When Deborah Vauclare cares for her 6-year-old son, Lo who has a rare genetic disease that a doctor has told the family could be described as "Parkinson's mixed with Alzheimer's, affecting kids," according to Vauclare she often has a helper in the form of his little sister, Eva.

"She'll kiss him and help me if his head falls," Vauclare said, adding, "She doesn't understand because she's only 3, but she likes to be with him."

Watching Eva's tenderness toward Lo gives the family some comfort, Vauclare said, as they face an uncertain future. Medical experts have told them to brace themselves for the worst. The 41-year-old mom said they told her that the maximum time that Lo has left is about four years.

"We try not to say 'poor boy' in front of Eva," Vauclare said. "But it's something we often say because the life that he lives is unimaginable."

When he was 2 years old, Lo received a diagnosis of infantile neuroaxonal dystrophy, or INAD, a neurodegenerative condition. Its symptoms of dementia are similar to those in diseases such as Alzheimer's and Parkinson's in adults. About 150 children worldwide are known to have it, Vauclare said.

One of the causes of INAD is a missing enzyme in people's bodies as well as a dangerous accumulation of iron. It often results in blindness, poor motor function, seizures, hearing loss, and problems with swallowing and breathing.

Vauclare, who learned of Lo's condition when she was five months pregnant with Eva, was told that a recessive gene caused it, and that her unborn baby had a 25% chance of developing it, too.

"I was a complete wreck," said Vauclare, a New Yorker who lives in France with her 46-year-old husband, Antoine Vauclare. "I couldn't sleep. I couldn't eat and felt nauseous all the time from nerves."

Thankfully, Vauclare said, when Eva was at seven months' gestation, tests showed that she was free of the disease and would be born healthy. But, she added, the results couldn't take away their fears for Lo.

"We thought, 'How can this be?'" Vauclare said, adding, "We thought, 'How could our child or any child be given this life, which is really not much of a life?'"

Lo began to show symptoms of the condition when he was 14 months old. He failed to meet the usual developmental milestones. In addition to issues such as speech delay, his balance "was off," and he "kept falling down," Vauclare said. He was assessed by therapists before having routine tests, such as an MRI and EEG. But "the disease didn't show up yet," Vauclare said.

The family underwent genetic testing in June 2018 and learned that Lo had INAD. Vauclare said that, to their frustration, the doctors in Paris "seemed more concerned" about the baby she was carrying than about Lo.

"I remember being furious," she said. "They were saying, 'What about your daughter?' and insinuating, "Are you going to terminate your pregnancy?' and I was like, 'What are you going to do about our son?'"

Vauclare said they were handed a leaflet about INAD and left to research it themselves on the internet. She then came across the INADcure Foundation, which supports the families of the small number of children with the condition, and fought to find a cure for them and Lo.

In a race against time, the Vauclares joined forces with the charity to launch an initial $500,000 campaign called Bisous for Loto fund scientific research.

Lo was enrolled in an drug trial in Morristown, New Jersey, six months after his diagnosis. The research continued until 2021, when, Vauclare said, the company behind it went bankrupt. He was denied the chance to take part in a subsequent trial because his disease had become "too advanced," and "it would not only not help him but probably make it even worse," Vauclare said.

The Vauclares said they've watched Lo go from a smiling toddler to a child who's barely conscious of his surroundings. He has a feeding tube and a molded seat that supports his head and body.

Still, he goes every day to a special center that caters to children with disabilities. Vauclare said he receives aqua and light therapy to "help with his sensory needs." She believed that a highlight of his week was a "dog therapy" session where he and other kids got to "pet, feed, and train" the animals.

Meanwhile, the family clings to the hope that a scientific miracle could save Lo before it's too late. The INADcure Foundation needs to raise $7 million to pay for the development of a new gene-therapy treatment for the disease in the US.

"They say it's going to be ready in 18 to 24 months," Vauclare said, adding, "Will he be eligible for the trial? Does he have another 18 to 24 months to live?"

As they continue to wait, Vauclare said, Lo will always know that he is loved. His mom, dad, and little sister will protect him forever, she added: "The only thing I can really do now is to hold him for as long as I can."

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Boy has rare genetic disease, life expectancy is five to 10 years - Insider

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Preimplantation Genetic Testing Market Research | Industry Growing with Major Key Player Illumina, Inc (U.S.), SciGene Corporation (U.S.), Thermo…

Las Vegas, United States: Straits Researchs latest report on, Preimplantation Genetic Testing Market Global Industry Overview and Forecast 2022-2030, highlights potential, risk factor analyses, and enhanced with strategic and tactical decision-making assistance. The growth and regulatory factors impacting information consumption, the availability of highly dependable items in the market, and the improvement in operating efficiency of Preimplantation Genetic Testing industry players. The Global Preimplantation Genetic Testing Market is expected to reach USD 465.1 million by 2026 at a CAGR of 8.7% during the forecast period of 20192026. Preimplantation Genetic Testing Market Share report covers market trends and development, drivers, capacities, technologies, and the changing dynamics of the Preimplantation Genetic Testing Market.

Competitive Landscape

Some of the prominent players operating in the Preimplantation Genetic Testing market are Illumina, Inc (U.S.), SciGene Corporation (U.S.), Thermo Fisher Scientific Inc. (U.S.), Agilent Technologies, Inc. (U.S.), Yikon Genomics (U.S.), Oxford Gene Technology (UK), Rubicon Genomics, Inc. (U.S.), Natera, Inc. (U.S.), Abbott (U.S.), CooperSurgical, Inc (U.S.), and PerkinElmer Inc (U.S.).

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Studies explore the effects of COVID-19 on the upstream, midstream, and downstream sectors of the industry. In addition, this analysis provides extensive market estimations by putting an emphasis on data covering numerous factors that encompass market dynamics such as market drivers, market barriers, market opportunities, market risks, and industry news and trends.

This research also provides a dashboard view of prominent Organization, highlighting their effective marketing tactics, market share and most recent advances in both historical and current settings.

Global Preimplantation Genetic Testing Market: Segmentation

As a result of the Preimplantation Genetic Testing market segmentation, the market is divided into sub-segments based on product type, application, as well as regional and country-level forecasts.

By Procedure Type: Preimplantation Genetic Screening , Preimplantation Genetic DiagnosisBy Technology: Next-Generation Sequencing , Polymerase Chain Reaction , Fluorescence in Situ Hybridization , Comparative Genomic Hybridization , Single-Nucleotide PolymorphismBy Product and Service: Reagents and Consumables , Instruments , Software and ServicesBy Application: Aneuploidy Screening , Structural Chromosomal Abnormalities , Translocations , Deletions , Duplications , Inversions , X-Linked Disorders , HLA Typing , Single Gene Disorder Screening , Gender Identification

The report forecasts revenue growth at all the geographic levels and provides an in-depth analysis of the latest industry trends and development patterns from 2022 to 2030 in each of the segments and sub-segments. Some of the major geographies included in the market are given below:

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The Table of Contents and Figures of the Full Report are available for your perusal Preimplantation Genetic Testing Market Report with TOC

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Direct-To-Consumer (DTC) Genetic Testing Market Size, Scope, Growth Opportunities, Trends by Manufacturers And Forecast to 2029 This Is Ardee – This…

New Jersey, United States TheDirect-To-Consumer (DTC) Genetic TestingMarket research guides new entrants to obtain precise market data and communicates with customers to know their requirements and preferences. It spots outright business opportunities and helps to bring new products into the market. It identifies opportunities in the marketplace. It aims at doing modifications in the business to make business procedures smooth and make business forward. It helps business players to make sound decision making. Direct-To-Consumer (DTC) Genetic Testing market report helps to reduce business risks and provides ways to deal with upcoming challenges. Market information provided here helps new entrants to take informed decisions making. It emphasizes on major regions of the globe such as Europe, North America, Asia Pacific, Middle East, Africa, and Latin America along with their market size.

Such unique Direct-To-Consumer (DTC) Genetic Testing Market research report offers some extensive strategic plans that help the players to deal with the current market situation and make your position. It helps in strengthening your business position. It offers better understanding of the market and keep perspective to aid one remain ahead in this competitive market. Organizations can gauze and compare their presentation with others in the market on the basis of this prompt market report. This market report offers a clarified picture of the varying market tactics and thereby helps the business organizations gain bigger profits. You get a clear idea about the product launches, trade regulations and expansion of the market place through this market report.

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Key Players Mentioned in the Direct-To-Consumer (DTC) Genetic Testing Market Research Report:

23andMe, Ancestry, Karmagenes, Color, Genesis HealthCare, Family Tree DNA, Full Genomes, EasyDNA, Helix, Identigene.

Direct-To-Consumer (DTC) Genetic TestingMarket report consists of important data about the entire market environment of products or services offered by different industry players. It enables industries to know the market scenario of a particular product or service including demand, supply, market structure, pricing structure, and trend analysis. It is of great assistance in the product market development. It further depicts essential data regarding customers, products, competition, and market growth factors. Direct-To-Consumer (DTC) Genetic Testing market research benefits greatly to make the proper decision. Future trends are also revealed for particular products or services to help business players in making the right investment and launching products into the market.

Direct-To-Consumer (DTC) Genetic TestingMarket Segmentation:

Direct-To-Consumer (DTC) Genetic Testing Market, By Test Type

Predictive Testing Carrier Testing Nutrigenomics Testing Others

Direct-To-Consumer (DTC) Genetic Testing Market, By Technology

Single Nucleotide Polymorphism Chips Whole Genome Sequencing Targeted Analysis

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For Prepare TOC Our Analyst deep Researched the Following Things:

Report Overview:It includes major players of the Direct-To-Consumer (DTC) Genetic Testing market covered in the research study, research scope, market segments by type, market segments by application, years considered for the research study, and objectives of the report.

Global Growth Trends:This section focuses on industry trends where market drivers and top market trends are shed light upon. It also provides growth rates of key producers operating in the Direct-To-Consumer (DTC) Genetic Testing market. Furthermore, it offers production and capacity analysis where marketing pricing trends, capacity, production, and production value of the Direct-To-Consumer (DTC) Genetic Testing market are discussed.

Market Share by Manufacturers:Here, the report provides details about revenue by manufacturers, production and capacity by manufacturers, price by manufacturers, expansion plans, mergers and acquisitions, and products, market entry dates, distribution, and market areas of key manufacturers.

Market Size by Type:This section concentrates on product type segments where production value market share, price, and production market share by product type are discussed.

Market Size by Application:Besides an overview of the Direct-To-Consumer (DTC) Genetic Testing market by application, it gives a study on the consumption in the Direct-To-Consumer (DTC) Genetic Testing market by application.

Production by Region:Here, the production value growth rate, production growth rate, import and export, and key players of each regional market are provided.

Consumption by Region:This section provides information on the consumption in each regional market studied in the report. The consumption is discussed on the basis of country, application, and product type.

Company Profiles:Almost all leading players of the Direct-To-Consumer (DTC) Genetic Testing market are profiled in this section. The analysts have provided information about their recent developments in the Direct-To-Consumer (DTC) Genetic Testing market, products, revenue, production, business, and company.

Market Forecast by Production:The production and production value forecasts included in this section are for the Direct-To-Consumer (DTC) Genetic Testing market as well as for key regional markets.

Market Forecast by Consumption:The consumption and consumption value forecasts included in this section are for the Direct-To-Consumer (DTC) Genetic Testing market as well as for key regional markets.

Value Chain and Sales Analysis:It deeply analyzes customers, distributors, sales channels, and value chain of the Direct-To-Consumer (DTC) Genetic Testing market.

Key Findings:This section gives a quick look at the important findings of the research study.

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Direct-To-Consumer (DTC) Genetic Testing Market Size, Scope, Growth Opportunities, Trends by Manufacturers And Forecast to 2029 This Is Ardee - This...

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World IVF Day: 4 benefits of IVF treatment at the right age – Health shots

Infertility means the inability to conceive even after one year (or longer) of unprotected sexual intercourse. If you are struggling to get pregnant, youre not alone. A large number of people are battling infertility. Various factors such as stress, uterine fibroids, impaired sperm production, blocked fallopian tubes, low ovarian reserve, endometriosis, Polycystic Ovarian Syndrome (PCOS), and premature ovarian failure, can lead to infertility. But, In Vitro fertilization (IVF) treatment at the right age can be helpful for couples.

Age for IVF treatment matters. Couples who opt for the treatment in their early 30s have high chances of successful conception compared to couples in their later 30s because as they get older, the chances will reduce with time.

This revolutionary treatment is helping couples deal with infertility.

Genetic abnormalities are one of the more frequent causes of miscarriage. Preimplantation genetic testing (PGT) can be done in conjunction with IVF to determine in advance whether an embryo is genetically viable, assisting a woman in having a healthy pregnancy. What are you still holding out for? If you have been instructed to begin your IVF treatment immediately, do so.

The preimplantation genetic testing (PGT) on the embryo before it is transferred to the womans uterus will help one to deliver a healthy baby. There are two different kinds, such as PGT-A (preimplantation genetic testing for aneuploidy) and PGT-M (preimplantation genetic testing for monogenetic defects). PGT-A looks for an abnormal number of chromosomes in the embryo. PGT-M is done to know the risk for a specific inherited genetic condition like cystic fibrosis or Tay-Sachs Disease.

Also, read: World IVF Day: 9 things to know if you are opting for IVF treatment

IVF is a highly controlled process wherein only selected good quality eggs are used. And women in their 30s produce a good number of eggs. So, this treatment at an advanced age can raise ones chances of becoming pregnant.

Those who wish to focus on their careers can use IVF techniques if they want a baby in the later stages of life. Eggs or embryos can be cryopreserved for future use too. Also, you can choose a window of time when you want to be pregnant. Thus, it can be easy for you to become pregnant.

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World IVF Day: 4 benefits of IVF treatment at the right age - Health shots

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Global Metabolic Panel Testing Market to Grow with a CAGR of ~7% During 2022-2031; Market Growth to be Propelled by Increasing Prevalence of Chronic…

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Key Companies Covered in the Global Metabolic Panel Testing Market Research Report by Research Nester Are SYNLAB International GmbH, Abbott Laboratories, Quest Diagnostics, Inc., Laboratory Corporation of America Holdings, Sonic Healthcare Limited, Associated Regional and University Pathologists, Inc., Nova Biomedical Corporation, WerfenLife, S.A., Scion Lab Services, LLC, and other key market players.

New York, July 25, 2022 (GLOBE NEWSWIRE) -- It was noticed that around 2 million people globally pass away from the liver disease each year, with 1 million of those fatalities coming from cirrhosis complications, 1 million from viral hepatitis, and 1 million from hepatocellular carcinoma. Liver cancer is currently the 16th most prevalent cause of death worldwide, while cirrhosis is currently the 11th most common; together, they account for 3.5% of all fatalities worldwide and with a global burden of 1.6 and 2.1%, cirrhosis is one of the top 20 causes of disability-adjusted life years and years of life lost.

Research Nester has published a detailed market report on Global Metabolic Panel Testing Market for the forecast period i.e. 2022 2031 which includes the ongoing industry innovations and recent trends being adopted by the major industry players to achieve their business targets. Apart from that, the inclusive data on market size, growth rate, market revenue share, growth opportunities and challenges for the market players along with worldwide analysis on five major regions North America, Latin America, Europe, Asia Pacific and Middle East & Africa has been provided in the report.

As per the World Health Organization, in 2019, there were 38.2 million children under the age of 5 who were overweight or obese. Since 1975, there has been a more than 3-fold increase in global obesity. The global metabolic panel testing market is estimated to grow with a CAGR of ~7% over the forecast period on the back of rising global chronic disease prevalence namely kidney diseases, diabetes, and liver diseases. It was observed that the bulk of the approximately 422 million individuals with diabetes globally reside in low- and middle-income nations, and diabetes is directly responsible for 1.5 million fatalities annually. Along with these, rising rates of lifestyle-related illnesses, namely, obesity, along with the widespread adoption of unhealthy behaviors including smoking, alcohol consumption, and inactivity are also anticipated to propel significant market expansion during the forecast period.

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Furthermore, with the need for more advanced drugs and medical equipment to combat chronic diseases, the majority of the regions across the globe are predicted to significantly invest in research and development activities, which is further estimated to drive the market growth over the ensuing years. For instance, global research and development spending has more than tripled in real terms since 2000, rising from USD 677 billion to USD 2.2 trillion in 2019. In addition to this, the rising expenditure on healthcare across the globe on account of growing public awareness for the importance of early disease detection and treatment is estimated to boost the market growth over the forecast period. As per one of the health expenditure research reports, global health spending has increased overall during the previous 20 years, doubling in real terms, reaching USD 8.5 trillion in 2019 and 9.8% of GDP (up from 8.5% in 2000).

On the basis of geographical analysis, the global metabolic panel testing market is segmented into five major regions including North America, Europe, Asia Pacific, Latin America, and Middle East & Africa region. Out of these, Asia Pacific region is estimated to hold the noteworthy market share over the forecast period on the back of the growing burden of chronic metabolic diseases, and a rising geriatric population in the area who is more prone to acquire chronic metabolic disorders. It is believed that by 2050, one in four people in the Asia Pacific region is estimated to be older than 60, and between 2000 and 2035, type 2 diabetes is predicted to climb by more than 150% in South Asia, aging and accompanying lifestyle changes are the main causes of the rapid increase. In addition to this, the rising healthcare infrastructure and increasing disposable income in the region are estimated to provide lucrative opportunities for market growth over the forecast period.

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On the other hand, the market in the North America region is estimated to hold the largest market share over the forecast period owing to the rising number of people opting for regular medical check-ups and increasing expenditure on the healthcare sector on account of the large patient pool in the hospital for on-time diagnostic and treatment of the diseases. As per the Centers for Medicare & Medicaid Services, hospital spending rose 6.4% to USD 1,270.1 billion in 2020, a little faster rate of growth than the 6.3% growth in 2019. Additionally, the increasing consumption of fast food and calorie-dense food, which is leading the region to a higher obesity rate, and increasing medical costs to treat obesity are predicted to drive the market growth over the forecast period. It was observed that, in the years 2015 to 2018, 36.3% of young people between the ages of 2 and 19 ate fast food at least once a day, and in 2019, the estimated yearly medical cost of obesity in the United States was close to USD 173 billion.

The study further incorporates Y-O-Y growth, demand & supply and forecast future opportunity in North America (U.S., Canada), Europe (U.K., Germany, France, Italy, Spain, Hungary, Belgium, Netherlands & Luxembourg, NORDIC [Finland, Sweden, Norway, Denmark], Poland, Turkey, Russia, Rest of Europe), Latin America (Brazil, Mexico, Argentina, Rest of Latin America), Asia-Pacific (China, India, Japan, South Korea, Indonesia, Singapore, Malaysia, Australia, New Zealand, Rest of Asia-Pacific), Middle East and Africa (Israel, GCC [Saudi Arabia, UAE, Bahrain, Kuwait, Qatar, Oman], North Africa, South Africa, Rest of Middle East and Africa).

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The global metabolic panel testing market is segmented by disease into kidney diseases, diabetes, liver diseases, and others. Out of these, the kidney diseases segment is predicted to hold the largest market share over the forecast period owing to the rising incidence of kidney ailments and the quick change in people's lifestyles around the world. It was noticed that, adults in the US are thought to have chronic kidney diseases (CKD) in about 37 million cases, most of which go untreated and around 360 people start receiving dialysis for kidney failure every 24 hours. In addition to this, the patient-friendly healthcare policies in developed and developing regions to treat CKD and end-stage renal diseases (ESRD) are estimated to drive the segment growth over the forecast period. For instance, in the USA, patients with CKD required USD 87.2 billion in treatment in 2019, while those with ESRD required an extra USD 37.3 billion.

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Further, the global metabolic panel testing market is segmented by end user into point-of-care centers and laboratories. Out of these, the laboratories segment is estimated to gain significant market share over the forecast period owing to the high spending by patients to receive test results from reputable laboratories and their association with blood banks, hospitals, and specialist diagnostic centers. It is believed that by 2024, the medical and diagnostic laboratories in the United States are estimated to generate around USD 54 billion in revenue. In addition to this, the release of precise and cutting-edge devices including companion diagnostics, biochips, microarrays, and other technological advancements in the laboratories segment are estimated to drive the segment growth over the forecast period.

The global metabolic panel testing market is also segmented on the basis of test type.

Global Metabolic Panel Testing Market, Segmentation by Test Type

Electrolytes

Proteins

Kidney Tests

Glucose

Liver Functional Tests

Others

Some of the prominent key players and their company profiling mentioned in the global metabolic panel testing market research report include SYNLAB International GmbH, Abbott Laboratories, Quest Diagnostics, Inc., Laboratory Corporation of America Holdings, Sonic Healthcare Limited, Associated Regional and University Pathologists, Inc., Nova Biomedical Corporation, WerfenLife, S.A., Scion Lab Services, LLC, and other key market players. The profiling enfolds growth opportunities, challenges, and market trends prevalent for the growth of the market.

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Global Metabolic Panel Testing Market to Grow with a CAGR of ~7% During 2022-2031; Market Growth to be Propelled by Increasing Prevalence of Chronic...

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3 Reasons to Buy This Sizzling Growth Stock – The Motley Fool

Buying companies with proven products or services that are operating in thriving industries is a must for growth investors. Genetic testing is one such industry. There has been an increase awareness and interest in testing for genetic disorders and cancers. That's why Allied Market Research predicts that the genetic testing industry will grow at a 10.1% annual rate, reaching $21.3 billion by 2027.

With a $1.9 billion market capitalization, Veracyte (VCYT 0.53%) is a lesser-known name in the industry. The company leverages genomic technology to help physicians more confidently diagnose and treat chronic conditions. The thought is that this will lead to better treatment outcomes for patients. The company's tests are used to diagnose and guide treatment decisions for conditions like lung cancer, prostate and bladder cancers, thyroid cancer, breast cancer, and colon cancer.

Here are three reasons why growth investors may want to familiarize themselves with the medical diagnostic company and consider buying its shares.

Veracyte reported $67.8 million in revenue for the first quarter ended March 31, up 84.7% from the year-ago period. This was much higher than the $62 million that analysts were expecting in the quarter. So how did the genetic test maker exceed analysts' predictions for the 10th quarter out of the last 10 quarters?

Testing revenue of $56 million in the first quarter accounted for the vast majority of Veracyte's total, and it was up 69.2% year over year. The deferral of diagnostic tests in past quarters acted as a coiled spring for the company in the first quarter. This explains how its test volumes soared 61% higher over the year-ago period to 23,245 during the quarter.

Veracyte's biopharmaceutical and other revenue surged to $8.8 million in the first quarter. This was much higher than the $0.6 million in revenue recognized for the first quarter of the prior year, which was due to contributions from the acquisition of the immuno-oncology company HalioDx last August. Meanwhile, product volume for Veracyte's ProSigna breast cancer tests dropped 2.6% year-over-year to $3 million for the first quarter. Minimal test volume growth was more than neutralized by a 5% currency headwind during the quarter.

As pent-up demand for its products wanes, Veracyte expects that revenue growth will significantly moderate in the remaining three quarters of the year. The pent-up demand stems from less diagnostic tests being performed in the early days of the COVID-19 pandemic. Now that deferred diagnostic tests are finally being completed, there will be less of a demand going forward.

Even so, the company is forecasting $270 million in midpoint revenue for the year. This equates to a 23% growth rate over 2021. And analysts believe that growth will remain just as strong in 2023 at 19%.

Image source: Getty Images.

Another important reason why analysts are optimistic about Veracyte's future prospects has to do with the company's rock-solid balance sheet. Veracyte boasts a $163.6 million cash balance against $1.1 million long-term debt. Thus, the company is sitting on a net cash balance of $162.5 million, which is equivalent to over 8% of its market capitalization. This should give Veracyte the funds necessary to execute bolt-on acquisitions and future product launches.

Since Veracyte is more focused on revenue growth than profitability, the price-to-earnings ratio would be of no use in valuing the stock. That's why I would argue that the price-to-sales (P/S) ratio is more appropriate for Veracyte -- and currently it is trading at a multiple of seven. Considering that Veracyte is growing at a rate of around 20% annually, this is arguably a solid entry point for growth investors.

Kody Kester has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Veracyte. The Motley Fool has a disclosure policy.

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Monkeypox, yet another health emergency for world to cope with – China Daily

A person arrives to receive a monkeypox vaccination at the Northwell Health Immediate Care Center at Fire Island-Cherry Grove, in New York, US, July 15, 2022. [Photo/Agencies]

The World Health Organization has declared that the monkeypox outbreak in multiple countries is now a public health emergency of international concern, the highest level of alert it can sound.

At a time when a similar alert issued against the COVID-19 pandemic remains in place, identifying monkeypox as another public health emergency of international concern increase the global health challenge.

That WHO upgraded the outbreak from a pandemic to a public health emergency of international concern in just a month goes to show how fast the situation has changed. Altogether 16,000 monkeypox cases have been reported in 75 countries and regions around the world, with the number of confirmed infections increasing by 77 percent from late June to early July. Monkeypox used to be endemic to Africa, but now outbreaks have been reported from many countries and regions, including in Europe, the Americas and Asia.

The WHO has announced public health emergencies of international concern seven times in history. Aside from monkeypox, it has done so for influenza A(H1N1) virus in 2009, the wild poliovirus in 2014, the Ebola virus in West Africa in 2014, the Zika virus in Brazil in 2016, the Ebola virus in the Democratic Republic of the Congo in 2018-20 and the COVID-19 pandemic in 2020. The world is thus saddled with a new challenge even as it grapples with COVID-19.

Considering that no monkeypox cases have been reported on the Chinese mainland, China's current efforts should focus on preventing imported cases from abroad. In fact, the General Administration of Customs issued a notice as early as May 30, requiring all ports across the country to continue with measures to prevent the import of "multiple diseases".

China has established a variety of genetic testing techniques for the early diagnosis of monkeypox.

The National Health Commission has also issued a technical guide on monkeypox prevention and control, explicitly requiring its early detection, reporting, diagnosis, investigation and treatment. It has also raised specific requirements for the standardization of monkeypox epidemiological investigation, contact determination and management, laboratory testing and other work.

There is no need for the public to panic at this stage. The risk of infection can be effectively lowered by reducing gatherings, wearing masks, washing hands frequently and avoiding contact with wild animals.

- BEIJING NEWS

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Monkeypox, yet another health emergency for world to cope with - China Daily

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Rhinostics Launches the VERIstic to Redefine Small Volume Blood Collection – BioSpace

Novel Automated Design Enables Comfortable Home and Clinic Based Blood Collection with Robotic High-Throughput Processing

WALTHAM, Mass.--(BUSINESS WIRE)-- Rhinostics introduces another breakthrough in automated sample collection technologies with the launch of the patent-pending VERIstic Collection Device focused on small volume blood collection. The VERIstic is ideal for use in at-home and clinician-assisted collection methods and is a highly efficient, high-throughput replacement for antibody, hormone and protein detection, sexually transmitted infections (STIs), dried blood spot (DBS) cards, genetic testing, clinical trials, and other applications enabled by a simple finger prick collection.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220725005248/en/

The VERIstic is the first of its kind collection device combining tried-and-true capillary blood collection with an integrated, automation-ready cap to save time, money, and hassles in a hands-free workflow when the sample reaches the laboratory. For patients and clinicians, the collection is rapid, simple, and comfortable. Once the finger is pricked with a lancet, 50 L of blood is instantly wicked up the unique and patent-pending 3-sided capillary tube. The tube is screwed into its matching transport tube for shipment to the laboratory. When it reaches the laboratory, 96 samples can be accessioned in seconds through 2D barcodes located on the transport tube bottom followed by robotic decapping of the samples, rapid elution of the sample, and automated liquid handling technologies. With gentle agitation, blood elutes from the capillary tube and is immediately ready for processing while lab technicians are free to focus their attention elsewhere. (Photo: Business Wire)

Were very excited to bring this truly unique and simple innovation to the blood collection market, said Cheri Walker, PhD, President and CEO of Rhinostics. Finally, patients and clinicians can be assured of comfortable metered blood collection, where the clear capillary allows the collector to monitor collection and laboratories gain consistent blood collection combined with cost and time-saving efficiencies during processing through automated decapping and robotic sample processing.

This first of its kind collection device combines tried-and-true capillary blood collection with an integrated, automation-ready cap to save time, money, and hassles in a hands-free workflow when the sample reaches the laboratory. For patients and clinicians, the collection is rapid, simple, and comfortable. Once the finger is pricked with a lancet, 50 L of blood is instantly wicked up the unique and patent-pending 3-sided capillary tube. The tube is screwed into its matching transport tube for shipment to the laboratory. When it reaches the laboratory, 96 samples can be accessioned in seconds through 2D barcodes located on the transport tube bottom followed by robotic decapping of the samples, rapid elution of the sample, and automated liquid handling technologies. With gentle agitation, blood elutes from the capillary tube and is immediately ready for processing while lab technicians are free to focus their attention elsewhere. The VERIstic enables efficient, hands-free and low labor workflows.

VERIstic is suited for a range of applications including other small volume body fluids, blood monitoring, wound care, clinical trials, and a number of home- or clinic-based sample collection needs. Rhinostics will mark the global debut of this device at the 2022 AACC Annual Scientific Meeting & Clinical Lab Expo to be held July 26-28 in Chicago, IL.

About Rhinostics

Rhinostics is at the forefront of revolutionizing sample collection. As a spin-out company from Harvard University and Wyss Institute, we are taking a radical new approach to sample collection device design and function. We recognize that many automated microplate-based workflows are encumbered by manual steps at the workflows beginning, and aim to develop and commercialize elegant, automated collection devices to break through these bottlenecks. Using our advanced collection device technologies such as the RHINOstic Automated Swab, test kit manufacturers can empower comfortable yet high-end patient experiences with abundant and clean sample yields for tests from lateral flow to microfluidics; all while boosting profits and differentiating their brand. Test processing laboratories conducting sensitive assays from traditional PCR to LAMP or antigen testing and more gain 10x sample throughput compared to manual workflows for cost-effective and robust assay performance even when working with difficult samples; with labor reductions of 80+%, even during times of surging demand. Rhinostics aids testing workflows during the COVID-19 pandemic and beyond in areas like respiratory disease, genomics, STDs, forensic and much more. Rhinostics continues to innovate, launching the novel VERIstic Collection Device and with a development pipeline of improved sample collection devices that are purpose-built for their application combined with automation enablement. Rhinostics products are registered as Class I exempt medical devices with the U.S. FDA and may be used for clinical collection upon CLIA validation. In 2022, Rhinostics received a Bronze Edison Award in the COVID-19 Innovations, Testing Solutions category for the RHINOstic Automated Swab. To learn more, visit https://www.rhinostics.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220725005248/en/

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Rhinostics Launches the VERIstic to Redefine Small Volume Blood Collection - BioSpace

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Direct-To-Consumer (DTC) Genetic Testing Market Size, Forecast And Trend Analysis To 2028 This Is Ardee – This Is Ardee

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New Jersey, USA,-The Global Direct-To-Consumer (DTC) Genetic Testing Market study provides a comprehensive examination of the market throughout the projection period. The study covers a variety of sections as well as an analysis of the events and factors that are likely to play a significant role in the future. These elements, known as market dynamics, include the drivers, restrictions, options, and difficulties that shape the overall image of those components. The markets intrinsic components are the drivers and restraints, while the extrinsic components are the alternatives and difficulties. Throughout the forecast period, the Global Direct-To-Consumer (DTC) Genetic Testing Market report provides an insight on the markets performance in terms of revenue.

This research provides an all-encompassing assessment of the global Direct-To-Consumer (DTC) Genetic Testing market. The market estimations presented in the report are based on extensive secondary research, primary interviews, and in-house expert evaluations. These market estimations were developed by examining the impact of various social, political, and financial factors, as well as current market dynamics, on the Global Direct-To-Consumer (DTC) Genetic Testing Market.

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To ensure that the specific detailing of the Global Direct-To-Consumer (DTC) Genetic Testing markets footprint and sales demographics are captured with precision, an in-depth analysis of several regions is carried out, allowing the user to make the most of the data.

Market Segmentation:

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Segment by Types:

Segment by Applications:

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Regions Are covered By Direct-To-Consumer (DTC) Genetic Testing Market Report 2022 To 2028

For a comprehensive understanding of market dynamics, the global Direct-To-Consumer (DTC) Genetic Testing market is analyzed across key geographies namely: North America (United States, Canada, and Mexico), Europe (Germany, France, UK, Russia, and Italy), Asia-Pacific (China, Japan, Korea, India, and Southeast Asia), South America (Brazil, Argentina, and Colombia), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, and South Africa). Each of these regions is analyzed on the basis of market findings across major countries in these regions for a macro-level understanding of the market.

Direct-To-Consumer (DTC) Genetic Testing Market Report Scope:

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Industry Overview:The first section of the research study covers an overview of the global Direct-To-Consumer (DTC) Genetic Testing Market,market status and prospects,and product range. In addition,it provides highlights of the major segments of the global Direct-To-Consumer (DTC) Genetic Testing Market,i.e. region, type and application segments.

Competitive Analysis:This report illuminates important mergers and acquisitions,business expansion,product or service differences,market concentration,competitive status of the global Direct-To-Consumer (DTC) Genetic Testing Market, and market size by player.

Company Profiles and Key Data:This section covers companies profiling the major players in the global Direct-To-Consumer (DTC) Genetic Testing Market based on the aforementioned revenue,products,business and other factors.

Market size by type and application:In addition to providing in-depth analysis of the global Direct-To-Consumer (DTC) Genetic Testing Market size by type and application,this section provides research on top end users or consumers and potential applications.

Market Dynamics:This report covers the drivers, trends and opportunities of the global Direct-To-Consumer (DTC) Genetic Testing Market. This section also includes Porters analysis of five forces.

Findings and Conclusions:It provides strong recommendations for new as well as established players for securing a position of strength in the global Direct-To-Consumer (DTC) Genetic Testing Market.

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PSS: Providing quick and effective solutions – The Worldfolio

Japan is a leader in developing drugs and medical devices that are used worldwide. What contributions has Precision System Science (PSS) made to the medical field?

I learned the business from a domestic perspective, but I have a close relationship with an international partner who worked in Abbott before and since then, I have established connections with Roche and Thermo Fisher. As an SME, we have learned that big companies lack the inspiration to produce compact and easy-to-use products. PSS has received praise from larger companies for providing compact technology quickly and efficiently with highly accurate and precise diagnostic results. We will continue looking into what we can do as an SME and doing what major companies dont have the inclination to do themselves.

We have developed automated technologies that allow sample-to-result: nucleic acid extraction (DNA or RNA etc) to amplification and detection, and these can be used to conduct PCR testing quickly in just two hours. The equipment is small yet high-tech and we believe it is one of a kind. Our design concept is to develop devices that are small, compact, efficient, easy to use, and highly accurate and precise diagnostic results, therefore with features that large companies usually dont provide.

Magnetic filtration technology, or Magtration, is the core of our business. It uses magnetic beads and the system we have developed, and we realised that Magtration technology is very efficient in terms of sample preparation (nucleic acid extraction) of open systems in the field of molecular diagnostic and that is how the technology was developed. This is the very first automated sample preparation system that succeeded and thanks to this, we have received OEM orders from Roche and QIAGEN and have produced about 40,000 units so far.

Healthcare systems in many countries have been severely affected by the COVID-19 pandemic. As you mentioned, you have developed a fully automated PCR testing system that reduces testing time from six to two hours and removes the possibility of human error. How can such devices help mitigate the impact of future epidemics or pandemics, especially in countries with weak healthcare systems, such as developing and low-income nations?

PCR testing offers a high possibility of detection right after infection compared to protein-based antigen testing. If middle and low-income countries were to introduce a system to detect future infectious diseases, then PCR testing would be advantageous, and we would promote its adoption. About twenty years ago, we collaborated with the Japanese Red Cross Society to reduce serum hepatitis incidence after transfusions, and in addition to working with Roche, we were involved in preventing not only serum hepatitis, but also the spread of HIV and other diseases transmitted by blood, including through transfusions, by developing a device of sample preparation that could confirm contaminated blood combining a sample pooling method for multiple detection. Thanks to that, we have been able to significantly decrease the spread of hepatitis and HIV transmissible by blood.

In addition to our Magtration technology, we are developing a print-made cartridge. The systems used by major companies are becoming very complex and by providing this cartridge pre-filled with reagent and allowing any country in the world to use it new contaminants can be detected. We have also developed a soak stick kit: a saliva sample is taken, and the vial doesnt need to be filled with reagent by the testing machinery if used in combination with the cartridge. The saliva kit is combined with an inactive virus infection like COVID-19 solution, meaning the person conducting the test wont be infected.

8 years ago, we established a partnership with French company ELITech, who wanted to sell their PCR reagent with their machinery. The OEM product is sold as ELITe InGenius, but now we are developing a version called BeGenius which we have announced publicly. We have high expectations for providing our products to ELITech, in addition to evolving with them and gaining a stronger market presence.

At the same time, there are many challenges. One of them is that it takes two hours for us to get the fully automated results of the PCR test with highly accurate and precise diagnostic results, however we want to reduce this to less than an hour with the same quality of diagnostic results. To reach this goal, we will increase the speed of hardware movement, while also upgrading the software to be more efficient. We are doing our best to evolve this as a business, as well as contribute to society, by providing an automated PCR testing device that takes less time, and which would be particularly convenient for locations such as airports. It is also very compact, so placing it in these locations wouldnt be difficult.

The machine itself scans barcodes placed on the samples, however, to ensure that there are no mistakes, handwritten labels that the machine can recognise are also used. Since the process is automated, the samples arent at risk of being contaminated during testing. The testing kit is also packaged with the machine. It is still a medical device, so a person must be trained to operate it, but it is easy to use, therefore making mistakes less commonplace. Originally, our machines were used for organ transplant testing, but with the rise of infectious diseases, we decided to incorporate this type of testing too.

We recently completed our work with Kyoto University, with whom we collaborated on the development of a high-precision pool-based mass screening system for SARS-CoV-2 (the COVID-19) detection using a fully automated genetic testing device. In the validation study, a total of 2,448 saliva and swab samples were tested, and the results showed a sensitivity of 97.1% and a specificity of 99.9%, demonstrating the high accuracy of this system.

For example, in a context where multiple people are tested at the same time, such as an airport, and in which a small minority of people test positive, while the majority are negative, eight samples are tested simultaneously, allowing for immediate detection of the positive samples.

PSS Matsudo Head Office

geneLEAD VIII

PSS Shinjuku Laboratory

NPS & Odate Reagent Center

You have a highly diversified product line-up. What product or products are you currently focusing on?

Our business model has changed in response to the COVID-19 pandemic. We didnt produce reagents for PCR before, until we partnered with a European company providing them with the pre-packaged reagents. We have always been a machinery developer and have constantly asked ourselves what reagents should be used with our machinery for testing.

Your platform Bio System is an open system to provide solutions in a variety of fields, including oncology and stem cell research. Can you tell us more about it?

The Bio System is planned to extract very fine particles within the body: by extracting them using Magtration technology or the cartridge reagent, we can apply the procedure in many fields, including disease detection. Our strengths are in sample preparation and conducting the diagnosis. To take advantage of our this strengths by establishing a mass production supply chain of our Prefilled Reagent Cartridge for Magnetic Bead Based Nucleic Acid Extractions, we are constructing the second plant of the Odate Reagent Center (targeted to start operation in the first half of 2022).

The reagent manufacturing capacity will be significantly increased from approximately 6 million tests/year to approximately 36 million tests/year to meet various genetic testing needs including PCR testing.

You have an in-house R&D department in Ichikawa, in Chiba prefecture, where you are tirelessly developing new products. What is the centres focus?

Recently, our development has moved in the direction of finding applications for the research and technology that we have accumulated over time. Unlike other companies, which use 96 microplates as a standard, we adopt a unique approach where we focus on each specific sample. Combined with our technologies, this approach allows us to create new approaches, such as detecting diseases that were previously difficult to diagnose.

How will you achieve clinical diagnosis using genes? Are you looking for partners to create new products for this specific market?

We now work with academic institutions, both internationally and domestically, whereas beforehand we were only working with other medical companies. We usually do as much as we can by ourselves, as we want to establish our one-of-a-kind technologies and devices.

Recently, you opened an Inspection center in Shinjuku, Tokyo. What is a purpose of the Establishment of "PSS Shinjuku Laboratory" which have opened last October as a Sanitary Inspection Center?

Ons and academia. In order to achieve corporate citizenship, we will also conduct PCR testing for COVID-19 infections from corporate entities and plan to establish a business cooperation group with the aim of "establishing a system where anyone can receive fast & accurate PCR tests anytime, anywhere" by deploying such facilities not only in Japan but also on a global scale.

On account of its ageing population, Japan is facing the need to focus more on healthcare prevention, rather than treatment. How are you catering to this trend?

Alzheimers, for example, is very difficult to treat, more so than cancer, and many pharmaceutical companies have invested trillions of yen to develop a drug to treat it, but to no avail. What is important is that if you can detect Alzheimers 10 or 20 years before its onset, then you are in a better position to treat it and potentially avoid suffering being caused by the disease. The same applies to cancer. Early detection is very important, and we are trying to utilise our technologies to create ways to detect these diseases.

You are present in Germany and the United States. Could you tell us why you chose these locations?

The reason we have businesses there is that we have partners in those countries. Japan is behind when it comes to understanding the need for PCR technology. Instead, there is a higher demand in the American and European markets, and we are working as an OEM provider with our partners in those locations.

What is your strategy to further expand internationally?

We have received many offers to be purchased by larger companies, but we have declined them because we want the freedom to develop what we like. Currently, we have distribution partners in the United States, Spain, Italy, France, Belgium, and Sweden, among others. In our work with overseas companies, we have been providing OEM products, but we are aiming to develop a PSS brand and sell our products directly. For now, we believe our best option is to have partnerships with agents who understand our products well and develop good distribution networks.

Imagine we come back in four years time for PSSs 40th anniversary. What goals would you like to have achieved by then?

We want to enter niche fields that havent been entered yet. For example, the area of disease detection that we discussed earlier hasnt been dealt with successfully. We want to provide technology that caters to and provides solutions for such frontier areas.

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Prevencio Announces Agreement with Alivio Health Expanding Access to AI-Driven Cardiac HART Tests Offered by Atlas Genomics – Business Wire

KIRKLAND, Wash.--(BUSINESS WIRE)--Prevencio, Inc. today announces that Atlas Genomics, Prevencios performing laboratory for its Artificial Intelligence (AI)-driven cardiac HART blood tests, has entered into a preferred provider agreement with Alivio Health to provide expanded access for Prevencios HART tests. The coverage includes HART CVE, the only blood test available for assessing a patients one-year risk for a heart attack, stroke, or cardiac death, and HART CADhs for assessing a patients risk for significant blockage of a heart artery.

In conjunction with researchers and clinicians at Massachusetts General Hospital, HART test data has been presented at leading cardiology scientific sessions and has been published in peer-review journals. The HART tests are significantly more accurate than single protein blood tests, standard-of-care stress tests, clinical risk scores, and genetic tests. The HART tests are also accurate in patients with diabetes and chronic kidney disease, conditions that often confound other blood-based tests or have contraindications for dye-based imaging, including Cardiac Computed Tomography Angiograms (CCTA).

Prevencio is grateful for our laboratory partnership with Atlas Genomics and is excited to collaborate with Alivio Health to provide 125,000 Americans with increased access to our precision care HART tests, said Rhonda Rhyne, Prevencios Chief Executive Officer. Through Alivio Health, we intend to expand awareness, access, reimbursement, and utilization of HART cardiac tests for the benefit of patients. Our mission is preventing the preventable by providing patients, clinicians, and employers with personalized tests that are more accurate, safer, and more affordable for preventing, identifying, treating, and monitoring the tens of millions of patients with cardiac issues.

Cardiovascular disease is the leading cause of death in the U.S. and globally. According to the American Heart Association, the U.S. spends approximately $316 billion annually on cardiovascular disease and stroke, or approximately 10% of the $3.2 trillion spent on total healthcare. By 2030, more than 40% of the U.S. adult population is projected to have cardiovascular disease. For additional information, visit Prevencio, Inc.

About Prevencio, Inc.: Powered by AI, Prevencio is revolutionizing blood tests for cardiovascular disease and custom diagnostics. Prevencio utilizes Machine Learning (Artificial Intelligence) + Multiple Proteomic Biomarkers + Proprietary Algorithms to deliver cardiovascular diagnostic & prognostic tests that are significantly more accurate than standard-of-care stress tests, genetic tests, and clinical risk scores. Employing this novel approach, the company has developed seven blood tests that significantly improve diagnoses for a variety of heart and blood vessel-related complications. The company is headquartered in Kirkland, Washington. For additional information, visit Prevencio, Inc.

About Atlas Genomics: Atlas Genomics is a high-complexity, CLIA- and CAP-accredited molecular diagnostic laboratory headquartered in Seattle, Washington. Atlas has specialized in molecular and genetic testing since its inception in 2014, offering womens health, COVID 19, cardiovascular testing (via novel Prevencio HART tests), stem cell analysis, cytogenetics, and research testing in support of biotechnology companies nationwide. Atlas primary technologies include next generation sequencing (NGS), RT-PCR, and proteomics.

About Alivio Health: Alivio Health is a national genetic benefit solutions company committed to providing access to a comprehensive suite of molecular and advanced diagnostics enabling actionable insights for patients and their physicians. The constant and rapid expansion of genetic services has left laboratories and payers of healthcare incessantly navigating challenges around medical policy, coverage, and reimbursement. Alivio Health, through its comprehensive nationwide network of molecular and advanced testing laboratories, is facilitating access to the right test at the right time for employers and their employees. For additional information, visit Alivio Health.

Forward-Looking (Safe Harbor) Statement:

Prevencio cautions you that statements in this press release that are not a description of historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the expected benefits of the partnership with Alivio Health, including the availability and expected use of Prevencios tests through the Alivio Healths network, and any potential for increased use of HART tests. The Companies do not undertake to update disclosures contained in this press release.

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Prevencio Announces Agreement with Alivio Health Expanding Access to AI-Driven Cardiac HART Tests Offered by Atlas Genomics - Business Wire

Recommendation and review posted by Bethany Smith

Global Stem Cell Manufacturing Market Value Projected To Reach USD 21.71 Billion By 2029, Registering A CAGR Of 9.1% – Digital Journal

Global Stem Cell ManufacturingMarket Is Expected To Reach USD 21.71 Billion By 2029 At A CAGR Of 9.1 percent.

Maximize Market Research has published a report on theGlobal Stem Cell Manufacturing Marketthat provides a detailed analysis for the forecast period of 2022 to 2029.

Global Stem Cell ManufacturingMarket Scope:

The report provides comprehensive market insights for industry stakeholders, including an explanation of complicated market data in simple language, the industrys history and present situation, as well as expected market size and trends. The research investigates all industry categories, with an emphasis on key companies such as market leaders, followers, and new entrants. The paper includes a full PESTLE analysis for each country. A thorough picture of the competitive landscape of major competitors in theGlobal Stem Cell Manufacturingmarket by goods and services, revenue, financial situation, portfolio, growth plans, and geographical presence makes the study an investors guide.

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Global Stem Cell Manufacturing Market Overview:

Observing stem cells evolve into cells in bones, the circulatory system, nerve cells, and other organs of the body may help scientists understand how illnesses and disorders occur. Stem cells can be programmed to generate particular cells that can be utilized in humans to grow and mend tissues that have been damaged or harmed by sickness. Stem cell therapy may assist people with spinal cord injuries, metabolic disorders, Parkinsons disease, amyotrophic lateral sclerosis, Alzheimers disease, cardiovascular disorders, brain hemorrhage, burns, malignancy, and rheumatoid arthritis. Stem cells can be used to create new tissue for transplant and genetic engineering. Doctors are always learning more about stem cells and how they might be used in transplant and cellular therapies.

Global Stem Cell ManufacturingMarketDynamics:

Stem cells are crucial in illness treatment and specialized research initiatives such as customized therapy and genetic testing. As public and commercial stakeholders throughout the world become more aware of stem cells therapeutic potential and the scarcity of therapeutic approaches for rare illnesses, they are increasingly focusing on the development of stem cell-based technology.

Specialized procedures are required for stem cell separation, refinement, and storage (such as expansion, differentiation, cell culture media preparation, and cryopreservation). Additionally, the production scale-up of stem cell lines and associated items is frequently accompanied by major technological challenges that impede the whole production process and result in large operational expenses. As a result, stem cell products are frequently more expensive than pharmaceutical medications and biopharmaceuticals.

Additionally, the growing popularity of tailored medications is driving the market growth. Scientists are researching novel procurement strategies that can be used to manufacture tailored medications. For example, iPSC treatments are created by taking a little amount of a patients plasma or skin cells and reprogramming them to make new cells and tissue for transplant. As a result, future tailored treatments can be produced using these cells.

Global Stem Cell ManufacturingMarketRegional Insights:

North America (particularly the United States) held the largest market share in 2021, owing to factors such as the availability of significant contenders active in creating stem cell treatments, enhanced medical facilities, significant R&D financial backing available, and favorable initiatives from healthcare organizations, as well as robust reimbursement. Because of government initiatives and serious scientific activity in the country, the United States leads the continentsGlobal Stem Cell Manufacturingmarket.

Healthcare organizations are promoting cellular therapies for rising ailments. Due to higher advancement of stem cell-based treatments, federal actions for creating regenerative medications, the creation of multiple stem cell banks, and the continents increasing clinical studies for genetic manipulation and medical technology, the APACGlobal Stem Cell Manufacturingmarket is expected to grow at the fastest rate during the forecast period.

Global Stem Cell ManufacturingMarketSegmentation:

By Product:

By Application:

By Technology:

By Therapy:

Global Stem Cell ManufacturingMarket Key Competitors:

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Maximize Market Research is a multifaceted market research and consulting company with professionals from several industries. Some of the industries we cover include medical devices, pharmaceutical manufacturers, science and engineering, electronic components, industrial equipment, technology and communication, cars and automobiles, chemical products and substances, general merchandise, beverages, personal care, and automated systems. To mention a few, we provide market-verified industry estimations, technical trend analysis, crucial market research, strategic advice, competition analysis, production and demand analysis, and client impact studies.

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Global Stem Cell Manufacturing Market Value Projected To Reach USD 21.71 Billion By 2029, Registering A CAGR Of 9.1% - Digital Journal

Recommendation and review posted by Bethany Smith

NuFace Is Having a Major Sale During Amazon Prime Day 2022 See Deals on Trinity, NuBody, and More – Allure

ICYMI: Amazon Prime Day is coming to an end tonight and truth be told, the sales appear to be gifts that keep on giving. One of our favorite skin-care tools is having a major discount across all of its devices and treatments. Yep, you guessed it, it's NuFace.

If you're unfamiliar with the brand and the magic it can do, let us school you quickly. NuFace devices use microcurrent technology that the brand calls "fitness for your face." In the same way that consistently hitting weights and cardio whips our body's muscles into shape, the metal nodes on the head of the tools send electrical currents through the various layers of facial skin, down to the muscles, to basically give them a workout.

Into it? Well, lucky for you NuFace products will be available at a discount throughout this two-day epic sale. Starting right now through July 13, you can snag devices, boosters, and activators for up to 36 percent off. The sale includes top-selling products like the Trinity, NuBody, Fix, and more.

So what are you waiting for? This luxury tool rarely goes on sale so get to shopping because these discounts end later on when Prime Day closes its virtual doors.

NuFace Trinity Starter Kit

NuFace Trinity Complete Kit

Both the Trinity Starter Kit and Complete Kit are essentially the same thing, but the complete kit comes with some additional attachments. Both kits feature a NuFace device and a gel primer to apply prior in order to activate the current. However, the Complete Kit holds a dual wand that targets specific areas like around the lips and eyes and a LED light attachment that helps reduce the appearance of fine lines and wrinkles.

If you're not into breaking the $200 mark, consider the Mini Starter Kit it holds the same device and gel primer, just in a smaller (more portable!) version that achieves the same results.

The NuBody features those same nodes on the head as the Trinity but in a handheld body version that utilizes four nodes. With four electrical currents, this device sends waves through the skin down to the muscles to help sculpt and tone the body. Plus, you get a 10-ounce gel primer to ensure the device glides smoothly and evenly.

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NuFace Is Having a Major Sale During Amazon Prime Day 2022 See Deals on Trinity, NuBody, and More - Allure

Recommendation and review posted by Bethany Smith


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