Archive for the ‘Personalized Medicine’ Category

CAMBRIDGE, England--(BUSINESS WIRE)--

Lab21, the global specialist in personalized medicine and clinical diagnostics, is pleased to announce that routine analysis of clinical samples has begun from Lab21 Inc.s new CLIA laboratory in Greenville, South Carolina.

The first assays in the test menu include a new Human Papillomavirus (HPV) High Risk and HPV 16 and 18 Genotyping Service. Using the Roche COBAS 4800 HPV Genotyping test, Lab21 can identify high risk patients and differentiate those patients with HPV 16 and HPV 18 Genotypes. The Lab21 service launches concurrently with new guidelines for the prevention and early detection of cervical cancer which were recently issued by the American Cancer Society (ACS), the American Society for Colposcopy and Cervical Pathology (ASCCP), and the American Society for Clinical Pathology (ASCP).

Michael Bolick, President, Lab21 Inc said Over recent months we have grown the Greenville team and worked closely with local clinicians to prioritize the menu of tests required by local hospitals. The final validation of these assays and the receipt of our first patient samples are the culmination of Lab21s strong team work internationally. Our colleagues from the UK have developed best practices in molecular diagnostic testing that we have transferred, along with key individuals, into our US operations.

Lab21 Inc is focused on the provision of molecular diagnostic testing services in oncology and infectious disease. Launch of these services will include KRAS, EGFR and BRAF mutation analysis, HIV viral resistance and tropism and viral load assays. This follows Lab21s recent launch of the Clinical Genomics Center at ITOR, a hospital based cancer research organization located in Greenville, South Carolina. It is planned that through the partnership with ITOR, Lab21 will develop new companion diagnostic assays required to accompany new drug therapies.

Ken Morgan, Vice President Operations, Lab21 Inc said We welcome our new Laboratory Manager, Susan Foster, and Clinical Sequencing Group Leader, Jeremy Stuart to Lab21 Inc who are two very experienced clinical testing professionals from market leading companies. During the next 12 months we intend to grow our core team in Greenville rapidly as we add new test menu and launch our own companion diagnostic assays.

END

About Lab21

Lab21 is a global leader in personalized healthcare. It provides diagnostic products and services and supports blood bank screening, medical diagnostics and drug discovery. Lab21 customers include international healthcare providers, pharmaceutical and diagnostic companies. The Products division of Lab21 manufactures immunodiagnostic kits and reagents that are distributed internationally and is focused on infectious diseases for the blood-banking and clinical markets. Our clinical services operations have a growing test portfolio providing companion diagnostics and high technology molecular assays. Lab21's corporate offices are based in Cambridge, UK and Greenville, South Carolina, with a GMP manufacturing site in Cambridge and other manufacturing facilities in Newmarket, Camberley, Manchester and Bridport. Website: http://www.lab21.com

About the new guidelines for the prevention and early detection of cervical cancer

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Lab21 Unveils New Molecular Analysis Services at Greenville Site

25-04-2012 14:45 A plastic chip can whether a patient is resistant to cancer drugs or has diseases like malaria. The chip can also find infectious diseases in a herd of cattle. Source: Univ. of Alberta Read more:

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Lab-on-a-Chip Enables Personalized Medicine - Video

REDWOOD SHORES, CA--(Marketwire -04/25/12)- Oracle (ORCL - News)

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About Oracle Oracle engineers hardware and software to work together in the cloud and in your data center. For more information about Oracle (ORCL - News), visit http://www.oracle.com.

About Oracle in IndustriesOracle industry solutions leverage the company's best-in-class portfolio of products to address complex business processes relevant to health sciences, helping speed time to market, reduce costs, and gain a competitive edge.

About Moffitt Cancer CenterFollow Moffitt on Facebook: http://www.facebook.com/MoffittCancerCenter Follow Moffitt on Twitter: @MoffittNews Follow Moffitt on YouTube: MoffittNews

Located in Tampa, Moffitt Cancer Center is the only Florida-based National Cancer Institute Comprehensive Cancer Center, a designation that recognizes Moffitt's excellence in research and contributions to clinical trials, prevention and cancer control. Moffitt has 14 affiliates in Florida, one in Georgia, one in Pennsylvania and two in Puerto Rico. Moffitt is also a member of the National Comprehensive Cancer Network, a prestigious alliance of the country's leading cancer centers, and is listed in U.S. News & World Report as one of "America's Best Hospitals" for cancer.

TrademarkOracle is a registered trademark of Oracle and/or its affiliates. Other names may be trademarks of their respective owners.

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Moffitt Cancer Center Supports Personalized Medicine With Oracle Health Sciences Technology

LIVINGSTON, NJ--(Marketwire -03/30/12)- Inpatient Medical Associates (www.imahospitalists.com), a provider of hospitalist services, will debut its personalized iPad-based recruiting application at the Society of Hospital Medicine's annual meeting HM12, April 1-4, 2012, at the San Diego Convention Center. The medical group will also showcase its innovative approach in using scribes to support hospitalists' quality of practice.

"We identified the need to develop a personalized solution that quickly and effectively matches providers' practice preferences, recreational interests and geographical preference with available positions," explains Raymond Iannaccone, MD, FACEP, president and chief executive officer of Inpatient Medical Associates. "Through the eco-friendly app, recruiting information is sent electronically to interested providers before they even leave our exhibit booth."

The second innovation to dbut at HM12 is Inpatient Medical Associate's hospitalist-specific scribe program, which is intended to improve physician productivity, patient satisfaction and physician quality of practice. While emergency physician groups have used scribes for years, the practice is still new to hospitalists. The use of scribes has been shown to increase patient satisfaction and enhance physician productivity, which is critical in today's hospitalist practice where up to 34% of a hosptialist's time can be devoted to documentation, even when charting using an electronic medical record.

"Healthcare reform places greater emphasis on reducing lengths of stay, readmissions and supporting value-based purchasing. Our scribe program supports our commitment to achieving exceptional clinical and operational performance while remaining focused on patient satisfaction," states Maninder "Dolly" Abraham, MD, medical director for Inpatient Medical Associates.

Inpatient Medical Associates is exhibiting at Booth 213 at the 2012 Society of Hospitalist Medicine's annual HM12 conference in San Diego.

About Inpatient Medical AssociatesInpatient Medical Associates is an inpatient medicine practice providing hospitalist services at academic medical centers and community hospitals on the east coast. For more information, visit http://www.imahospitalists.com, http://www.twitter.com/IMAHospitalists or http://www.facebook.com/pages/Inpatient-Medical-Associates/104876569598099.

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Inpatient Medical Associates to Showcase Personalized Recruiting Application and Scribe Program at HM12 in San Diego

MOUNTAIN VIEW, California, March 29, 2012 /PRNewswire/ --

After witnessing a downtrend for several years, revenues in the U.S. nuclear medicine and positron emission tomography (PET) imaging systems market finally pivoted in 2010. New radiotracers and technologies are expanding the clinical scope and customer base of nuclear medicine and PET imaging. As a result, declines in retrenching areas of the market are poised to be offset by strong growth in emerging end-user market segments.

Nuclear medicine and PET are molecular imaging modalities, providing data pertaining to molecular alterations, which are the origin of disease. In contrast, classical imaging modalities, such as X-ray, reveal only the changes in anatomy, which are essentially the end effects of disease and its associated molecular alterations.

New analysis from Frost & Sullivans (http://www.medicalimaging.frost.com [http://www.frost.com/prod/servlet/svcg.pag/HCIM ]) U.S. Nuclear Medicine and PET Imaging Systems Market research finds that the market earned revenues of $552.4 million in 2010 and estimates this figure to reach $841.8 million in 2017.

If you are interested in more information on this research, please send an email to Britni Myers, Corporate Communications, at britni.myers@frost.com, with your full name, company name, job title, telephone number, company email address, company website, city, state and country.

"The unique ability of nuclear medicine and PET to enable characterization of biological processes at the cellular and molecular levels is bringing increasing attention to these imaging modalities as medicine evolves toward more personalized forms of treatment, " said Frost & Sullivan Industry Analyst Roberto G. Aranibar. "This powerful capability of nuclear medicine and PET will become increasingly relevant as personalized healthcare becomes mainstream practice in modern medicine."

Recognizing this advantage, industry participants are gravitating toward this area of imaging. As a result, nuclear medicine and PET imaging systems market revenues experienced a growth upsurge in 2010, and they are expected to continue growing for the next several years.

Molecular imaging has been a key enabling factor for treatment that is selected according to a patients unique disease state. For example, in cancer treatments, numerous chemotherapy options are available, and a patients response to a particular treatment can vary considerably based on the specific molecular characteristics of the cancer. With molecular imaging, however, clinicians can determine which characteristics are present in a cancer and use this information to make the most appropriate treatment decision on a patient-by-patient basis.

Ongoing challenges surrounding the state of the economy as well as changes in healthcare policy and reimbursement are forcing more private practice physicians and independent imaging centers to opt for affiliation with larger provider organizations. This shift in the healthcare provider landscape has led to rapidly diminishing revenues within the private practice cardiology market, which formerly accounted for a significant proportion of revenues in the more mature and established nuclear medicine segment of the market.

Naturally, the evolving healthcare provider landscape has led to changes in the types of imaging systems that are being demanded in the marketplace. For example, the need for dedicated cardiac scanners appears to be diminishing, as more cardiologists become affiliated with larger institutions that often benefit more from general-purpose scanners with a broader scope of clinical application.

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Frost & Sullivan: U.S. Nuclear Medicine and PET Imaging Systems Market Witnessed a Rebound in 2010, With PET Blazing ...

27-03-2012 13:19 G. Steven Burrill of Burrill & Company, reflects on current trends, challenges and the future of personalized medicine.

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G. Steven Burrill on Personalized Medicine - Video

The Worldwide Innovative Networking (WIN) Consortium in personalized cancer medicine proudly announces today that Foundation Medicine, Inc. (FMI), Cambridge, MA, joins WIN Consortium and becomes a member of the Consortium. The organizations' collaborative research strategy will be presented at the WIN2012 Symposium in Paris, France, on 28-29 June.

WIN Consortium, WIN2012, WIN Symposium, Worldwide Innovative Networking in cancer personalized medicine (Photo: Business Wire)

WIN Consortium, is a network of 22 academic institutions and industries across the globe, initiated by Cancer Institute Gustave Roussy (IGR), France and University of Texas MD Anderson Cancer Center, USA (MDACC), focusing on biomarker-driven therapeutic clinical trials conducted worldwide.

"The membership of Foundation Medicine, a CLIA certified laboratory using a next generation sequencing platform (NGS), is an opportunity for WIN to access their extensive screening test for aberrations in genes known to be associated with human cancer. WIN Consortium is sponsoring a unique clinical trial matching the genetics of patients' tumors and their responses to targeted therapies, to enable treatment with the therapies most likely to be effective against each individual patient's cancer. Foundation Medicine's participation will be a key strategic feature of WIN Consortium's innovative trial, conducted by Drs. Jean Charles Soria (IGR, France), Razelle Kurzrock (MDACC, USA), Josep Tabernero (VHIO, Spain) and Raanan Berger, (CSMC, Israel)," said Dr. John Mendelsohn, chairman of WIN Consortium.

"Foundation Medicine's industry and academic partnership through this international network complements the company's core cancer diagnostics capability, a fully informative genomic profile that provides physicians with clinically relevant molecular information designed to assist Oncologists in the selection of therapies for their patients and that to match patients with clinical trials specific for their tumor," said Michael J. Pellini, M.D., president and chief executive officer of Foundation Medicine. "The clinical trial to be announced during WIN2012, represents an important opportunity to use cutting edge NGS technology in an international setting for treatment decisions and we are proud to be supporting WIN Consortium with our platform."

"To hear more about the collaborative efforts of Foundation Medicine and WIN Consortium, join the WIN2012 Symposium in Paris on 28-29 June, a unique scientific event dedicated to the efficacy of personalized cancer therapeutics. Participants include outstanding investigators from academic institutions and industry - in an open exchange format. The WIN2012 scientific program received the endorsements of ASCO, ESMO, UICC and INCa (*). The WIN Symposium is a unique forum and networking opportunity. Plan your travel and register now as June is a busy period in Paris," said Vladimir Lazar, Chief operating officer of WIN Consortium.

Online abstract submission deadline is May 1st. Abstract will be published in a prestigious international journal, referenced on Pub Med. Early registration closed on April 1st.

About Foundation Medicine

Foundation Medicine is dedicated to improving cancer care through the development of comprehensive NGS cancer diagnostics that identify and interpret an ever-growing set of actionable genomic alterations. Founding advisors are world leaders in genome technology, cancer biology and medical oncology. Please visit the company's website at http://www.foundationmedicine.com.

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Foundation Medicine, Cambridge, MA, Joins WIN Consortium (Paris) and Becomes Member of the Worldwide Innovative ...

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Contact: Mary Steele Williams mwilliams@amp.org 301-634-7321 Association for Molecular Pathology

Bethesda, MD, March 21, 2012: "The Association for Molecular Pathology (AMP) applauds the U.S. Supreme Court's ruling today in the case of Mayo Collaborative Services v. Prometheus Laboratories as a victory for patients and for the advancement of personalized medicine," stated Iris Schrijver, MD, the Organization's President. AMP, an international professional society representing more than 2000 physicians, doctoral scientists, and medical technologists, joined 10 other medical and healthcare organizations in filing an amicus brief with the Court in support of Mayo Clinic. AMP is also the lead plaintiff in Association for Molecular Pathology v. U.S. Patent and Trademark Office that challenges the validity of patents on two human genes associated with hereditary breast and ovarian cancer and is currently under review by the High Court.

"Prometheus acknowledged that physicians can infringe the patent by merely thinking about the relationship between drug metabolite levels and patient response," asserted Dr. Schrijver. "It is encouraging that the Court recognized that the Prometheus patents neither promote the advancement of medical practice, nor benefit patient care".

"In Prometheus, the Court wisely recognized that overly broad patents can inhibit innovation," stated Jennifer Hunt, MD, MEd, the Organization's President-Elect. "Establishing a drug reference range is important, but standard work for laboratory physicians. Awarding monopolies over the medical use of natural, biological relationships stifles innovation in true diagnostic test methods and obstructs improvements for patient care."

AMP believes the Supreme Court's reasoning in Mayo v. Prometheus extends to patents that claim ownership over another type of natural phenomenon, the biological relationships between genetic variants and clinical disease. Such relationships are at the heart of personalized medicine. "Patients are increasingly being disadvantaged by gene correlation patents," stated Roger D. Klein, MD, JD, Chair of AMP's Professional Relations Committee. As an example, Dr. Klein cited a method patent relating to a variation in a gene known as FLT3 that is used to qualify some leukemia patients for bone marrow transplant.

Enforcement of the FLT3 patent by a private company has been forcing physicians and laboratories to split and geographically distribute irreplaceable bone marrow specimens. "Splitting samples creates an additional risk of specimen loss and delays the receipt of patient results" stated Dr. Klein. "In addition, it interferes with the ability of pathologists to provide synoptic interpretations involving multiple tests, and prevents them from implementing cost saving algorithms that limit unnecessary testing. The Supreme Court's ruling is clearly a win both for our patients and for personalized healthcare."

###

ABOUT AMP:

The Association for Molecular Pathology (AMP) is an international medical professional association dedicated to the advancement, practice, and science of clinical molecular laboratory medicine and translational research based on the applications of molecular biology, genetics, and genomics. For more information, please visit http://www.amp.org.

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AMP applauds Supreme Court ruling: Sees win for patients and personalized medicine

In a unanimous ruling the US Supreme Court has rendered invalid two patents covering a method for determining proper drug dosage. The 20 March decision sent ripples through the medical diagnostics industry, which has been closely following the case.

The patents were held by Prometheus Laboratories, a therapeutics and diagnostics company based in San Diego, California. They covered the process of administering thiopurine drugs which are used to treat autoimmune diseases such as Crohns disease to patients and then measuring the levels of certain metabolites in the blood to determine whether the patient had received a safe and effective dose.

A new landmark for patent law?

Daderot

The defendant in the case, a division of the Mayo Clinic, based in Rochester, Minnesota, initially bought diagnostic tests based on the patents, but in 2004 decided that it wanted to market its its own test, which uses a similar method. Prometheus sued in June of that year, and the case has been working its way through the courts ever since.

The medical-diagnostics industry has been shaken by recent legal challenges to its patents, most notably a high profile case challening the validity of gene patents held by Myriad Genetics, a diagnostics company based in Salt Lake City, Utah (see 'US Court upholds Myriad's breast cancer gene patents'). Critics argue that some of the patents being challenged are based on natural phenomena, which are not patentable unless they have been somehow altered by humans. The Supreme Court agreed, a decision which sent the share prices of some biotechnology companies tumbling; Myriad's stock dropped by more than 5%.

The ruling is also likely to send companies and universities scrambling to determine which of their discoveries are still eligible for patenting, says William Simmons, a patent attorney at the law firm Sughrue Mion in Washington DC. There are going to be areas of technology that are methods for treating individuals that simply cannot be patented as a result of this decision, he says. It has a dramatic impact on the medical community and the scientific research community.

In 2010, the US Court of Appeals for the Federal Circuit sided with Prometheus and upheld the patents, saying that the administration of drugs to patients and the measurement of metabolites in the blood were both steps that transformed a particular article into a different state or thing. But the Supreme Court disagreed. Neither step was transformative, wrote Justice Stephen Breyer, arguing instead that the patents covered a law of nature. Harking back to the archetypal eureka moment of antiquity, Breyer wrote: Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine whether an object will float.

Such a position is strongly opposed by the biotechnology industry, which has said that overturning the patents could stifle innovation, particularly in the development of personalized medicine. In a statement released after the court issued its decision, Hans Sauer, deputy general counsel for intellectual property at the Biotechnology Industry Organization, a Washington DC-based lobbying group, cautioned against unintended consequences of the decision for patents on biomarker-based diagnostic methods. The Court's opinion fails to appropriately recognize the importance of personalized medicine, he wrote, and of the research and investment incentives needed to develop new individualized therapies for untreated diseases.

In contrast, Breyer argued that upholding rather than striking down the patents risked inhibiting future innovation, a danger that becomes acute when a patented process is no more than a general instruction to 'apply the natural law'.

Excerpt from:
US Supreme Court upends diagnostics patents

SHAPE Urges NIH to Adopt Personalized Medicine for Heart Attack Prevention

Houston, TX (PRWEB) March 17, 2012

One of the most important developments is the use of noninvasive imaging to diagnose atherosclerosis in its pre-symptomatic stage. While detection and treatment of traditional risk factors such as high cholesterol and high blood pressure are important, it is now clear that the direct measurement of atherosclerosis, which enables personalized risk assessment, is useful in identifying high risk individuals and improves risk classification.

In fact, in the 9 years since the NIH released NCEP-III Guidelines which introduced Global Risk Assessment, subclinical atherosclerosis has gained increased recognition as a more powerful predictor than all risk factor combinations and risk factor-based scoring systems. The burden of atherosclerotic plaques predicts adverse events much more accurately than risk factors, particularly near-term events.

Consequently, in 2009, the Appropriate Use Criteria considered coronary artery calcium scans (CAC) appropriate for asymptomatic patients with an Intermediate global risk estimate, as well as those deemed lower risk with a family history of premature coronary heart disease. In 2010, the ACC/AHA Guideline for Assessment of Cardiovascular Risk in Asymptomatic Adults followed suit, elevating CAC and carotid plaque and intima-media thickness (CIMT) to Class IIa recommendations for cardiovascular risk assessment in asymptomatic adults at intermediate (10% to 20% 10-year) risk.

As we await the NCEP IV Guidelines, the SHAPE Task Force anticipates that the discoveries of the past decade will be incorporated in the NCEP Adult Treatment Panel (ATP) IV, and that the NIH will assign a major role to detection of subclinical atherosclerosis to improve risk prediction for primary prevention of atherosclerotic cardiovascular disease.

The Guidelines should no longer favor intensive treatment of cholesterol independent of atherosclerosis, but instead must target those individuals with the highest burden of atherosclerotic CVD risk who are expected to benefit the most from aggressive cholesterol-lowering therapies. The heightened awareness of possible statin induced hyperglycemia (diabetes mellitus) and rare cognitive dysfunction reinforces the need for more accurate risk assessment to insure that widespread drug therapy is appropriately implemented.

The SHAPE Task Force therefore suggests changing the name of the National Cholesterol Education Program to the National Atherosclerosis Education Program. This change will appropriately shift the focus from a single risk factor of atherosclerosis (cholesterol) to atherosclerosis itself, and can help save the lives of many High Risk individuals, who are currently misclassified as Low or Intermediate Risk.

SHAPE is continuing its scientific quest for innovative approaches to heart attack prevention, and ultimately, eradication. As an educational nonprofit organization, SHAPE advocates only the most scientifically proven approach, independent of specific practices or procedures. SHAPE is actively supporting the Department of Health & Human Services Million Hearts initiative to prevent one million heart attacks and strokes over five years.

Members of the SHAPE Task Force include:

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SHAPE Task Force Calls for Changing National Cholesterol Education Program (NCEP) to National Atherosclerosis ...

15-03-2012 11:26 Daniel A. Osman, MD, breast cancer surgeon, program director, Miami Breast Cancer Conference, discusses the Miami Breast Cancer Conference (MBCC), which took place at the Fontainebleau Miami Beach hotel, in Florida, March 14-17, 2012. During the span of the MBCC the central theme of the meeting has been to make everything you learn instantly applicable. As the conference enters its 29th year, this thesis remains true with a focus on the use of genomics and personalized medicine. The esteemed presenter Charles M. Perou, PhD, discussed the topic of personalized medicine in his presentation on sequencing-based genomics. Perou led research in 2002, shortly after the genome was mapped, that discovered 5 biologically different subtypes of breast cancer. These subtypes have led to enhanced prognoses and treatments for breast cancer patients, which has helped herald a new era in breast cancer management.

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Dr. Osman on the 29th Miami Breast Cancer Conference - Video

Self-experimentation is a venerable tradition in science.

London surgeon John Hunter deliberately gave himself gonorrhea (and inadvertently, syphilis) in 1767 and suffered from effects of the diseases in his old age.

Now Michael Snyder has joined their ranks.

The geneticist didn't risk life and limb, but he did sacrifice his privacy inviting colleagues to sequence his DNA and track tens of thousands of markers in his blood over a period of 14 months, when he was sick and when he was well, ultimately crunching billions of measurements on the molecular details of his body.

Some of the results came as big, and not very welcome, surprises, uncovering, among other things, that he was at risk for Type 2 diabetes, and capturing the precise moments when the disease took hold in his body.

Snyder, who heads the genetics department at Stanford University's medical school, says the work is more than just a curiosity. He thinks that his experiment, published Thursday in the journal Cell, offers a taste of what medicine may be like someday for everyone.

Physicians talk often about "personalized medicine": the idea that therapies should be tailored to each patient's unique genetic and medical profile. Doctors already practice a sort of personalized medicine when they "type" a tumor to find the most effective chemotherapy drug. Someday, scientists like Snyder say, it will be a routine part of prevention too.

But if the gantlet his team ran is any indication, that day isn't upon us yet.

First, the researchers sequenced Snyder's genome the 6 billion letters of his DNA blueprint several times over, to assess his risk for various conditions. (And they sequenced Snyder's mother's genome as well, to learn which genes he got from each parent.) They drew Snyder's blood regularly to see how proteins, RNA and a swath of other chemicals in his body increased or decreased when he was in good health and bad his "omics" profile. They monitored his immune system and other health measures.

"Your genome shows what you're predisposed for. Your 'omics' profile tells you what's really going on," Snyder said. "This is a whole new level."

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Geneticist's 'personalized medicine' study focuses on himself

Michael Snyder observed the onset of his type 2 diabetes while following a range of physiological variables.

S. Fisch

The future of personalized genomic medicine can be glimpsed today in a paper that reports the integration of lead author Michael Snyder's genomic sequence with other omics to give a read-out on his predisposition to disease, and his bodys response to viral infections and the onset of type 2 diabetes1.

As a proof-of-principle example of personalized genomic medicine, it is distinct from other studies because it applies whole-genome diagnostics to a healthy person rather than to individuals with disease.

Snyder, a geneticist at Stanford University School of Medicine in California, joins the swelling ranks of researchers who have publicly aired their own genome sequence. Some scientists question whether the latest work has much to add to the field. Richard Gibbs of Baylor College of Medicine in Houston, Texas, has humorously dubbed it the narciss-ome.

"A criticism of this paper is that its anecdotally about one person, but thats also its strength, says geneticist George Church of Harvard Medical School in Boston, Massachusetts. Large-scale association studies trying to tease out the genetic variants of complex disease often make the mistake of trying to achieve statistical significance by lumping together an enormous number of people that dont necessarily belong together, says Church.

Snyders integrative personal omics profile dubbed iPOP was created by merging his genomic sequence with RNA, protein, metabolic and auto-antibody profiles taken 20 times over a 14-month period. The results revealed Snyder to be genetically predisposed to type 2 diabetes, despite his having no family history or other risk factors. During the study, his blood glucose levels escalated following the second of two viral infections, and he was subsequently diagnosed with the disease. Snyder has since made drastic dietary and lifestyle changes to manage his blood sugar levels.

Snyder and his colleagues followed the changes in real time and report the activation of molecular pathways not previously implicated in viral infection or the onset of type 2 diabetes. By doing longitudinal studies of many more individuals as they transition through healthy and disease states, Snyder thinks it will be possible to uncover new mechanisms involved in disease and the bodys immune and stress responses.

Church agrees. We need more practise looking at individuals. Medicine treats people as individuals and we should be conducting research with a similar attitude. In 2006, Church initiated the Personal Genome Project to sequence the genomes of 100,000 volunteers including his own, which was one of the first ten to be analysed.

Snyder thinks it is ridiculous that standard medical evaluations, or 'work-ups', examine only a few dozen biomedical markers when current technology can generate a multitude more his paper reports more than 3 billion measurements of molecular components. However, interpreting such a vast amount of data for multiple individuals would cause a bottleneck. To this end, Snyder was one of the founders who last August launched Personalis, a company based in Palo Alto, California, with the aim of interpreting genomes for research groups.

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The rise of the 'narciss-ome'

ScienceDaily (Mar. 15, 2012) Geneticist Michael Snyder, PhD, has almost no privacy. For more than two years, he and his lab members at the Stanford University School of Medicine pored over his body's most intimate secrets: the sequence of his DNA, the RNA and proteins produced by his cells, the metabolites and signaling molecules wafting through his blood. They spied on his immune system as it battled viral infections.

Finally, to his shock, they discovered that he was predisposed to type-2 diabetes and then watched his blood sugar shoot upward as he developed the condition during the study. It's the first eyewitness account -- viewed on a molecular level -- of the birth of a disease that affects millions of Americans. It's also an important milestone in the realization of the promise of truly personalized medicine, or tailoring health care to each individual's unique circumstances.

The researchers call the unprecedented analysis, which relies on collecting and analyzing billions of individual bits of data, an integrative Personal "Omics" Profile, or iPOP. The word "omics" indicates the study of a body of information, such as the genome (which is all DNA in a cell), or the proteome (which is all the proteins). Snyder's iPOP also included his metabolome (metabolites), his transcriptome (RNA transcripts) and autoantibody profiles, among other things.

The researchers say that Snyder's diabetes is but one of myriad problems the iPOP can identify and predict, and that such dynamic monitoring will soon become commonplace. "This is the first time that anyone has used such detailed information to proactively manage their own health," said Snyder. "It's a level of understanding of health at the molecular level that has never before been achieved."

The research was published in the March 16 issue of Cell. Snyder, who chairs the Department of Genetics, is the senior author. Postdoctoral scholars Rui Chen, PhD, George Mias, PhD, Jennifer Li-Pook-Than, PhD, and research associate Lihua Jiang, PhD, are co-first authors of the study, which involved a large team of investigators.

The study provides a glimpse into the future of medicine -- peppered with untold data-management hurdles and fraught with a degree of self-examination and awareness few of us have ever imagined. And, despite the challenges, the potential payoff is great.

"I was not aware of any type-2 diabetes in my family and had no significant risk factors," said Snyder, "but we learned through genomic sequencing that I have a genetic predisposition to the condition. Therefore, we measured my blood glucose levels and were able to watch them shoot up after a nasty viral infection during the course of the study."

As a result, he was able to immediately modify his diet and exercise to gradually bring his levels back into the normal range and prevent the ongoing tissue damage that would have occurred had the disease gone undiagnosed.

Snyder provided about 20 blood samples (about once every two months while healthy, and more frequently during periods of illness) for analysis over the course of the study. Each was analyzed with a variety of assays for tens of thousands of biological variables, generating a staggering amount of information.

The exercise was in stark contrast to the cursory workup most of us receive when we go to the doctor for our regular physical exam. "Currently, we routinely measure fewer than 20 variables in a standard laboratory blood test," said Snyder, who is also the Stanford W. Ascherman, MD, FACS, Professor in Genetics. "We could, and should, be measuring many, many thousands."

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Revolution in personalized medicine: First-ever integrative 'Omics' profile lets scientist discover, track his ...

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) PeaceHealth, a Washington state-based non-profit health system, has partnered with the P4 Medicine institute, or P4Mi, a non-profit consortium focused on applying personalized medicine in the clinic, the partners announced today.

PeaceHealth said that its partnership with P4 Medicine, which was launched in 2010 by the Institute for Systems Biology and The Ohio State University, will ultimately provide its network of medical centers in Washington, Alaska, and Oregon with new genome-based predictive and diagnostic tools.

The non-profit said that it will work with P4Mi leaders to identify pilot projects that will be launched over the next two years in its medical practices and communities.

P4Mi is centered around the vision of advancing what Leroy Hood, ISB co-founder and president and chairman of P4Mi's board of directors, calls P4 medicine healthcare that is predictive, preventive, personalized, and participatory.

"PeaceHealth will help us integrate emerging biologic science into community-based care models, and make innovations in wellness and health accessible to whole communities," Hood said in a statement.

"Over time, we hope to take rapidly emerging P4Mi health and wellness innovations and integrate them into everyday interactions between PeaceHealth providers and their patients to better predict, prevent, and treat disease," added Peter Adler, PeaceHealth's senior VP for strategy, innovation, and development.

The partnership agreement makes PeaceHealth a founding community health partner of P4Mi, along with OSU's Center for Personalized Health at the Wexner Medical Center.

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Washington's PeaceHealth Joins ISB-led Personalized Medicine Initiative

ANN ARBOR, Mich., March 14, 2012 /PRNewswire/ --Everist Genomics (EGI), a rapidly-growing personalized medicine company, today announced the launch of the world's first comprehensive companion diagnostics and prognostics portfolio to improve early diagnosis, management and treatment of patients with colorectal cancer.

(Photo: http://photos.prnewswire.com/prnh/20120314/NY69822 )

(Logo: http://photos.prnewswire.com/prnh/20110110/NY26865LOGO )

The portfolio of four individual tests provides innovative gene expression profiling and analysis of molecular markers to help physicians track tumor development and responsiveness to therapy, enabling personalized treatment across all stages of colorectal cancer.

The tests will be available to U.S. customers starting at the end of March, which is Colorectal Cancer Awareness Month.

"Advances in molecular diagnostics and genomics have revealed that colorectal cancer is not a single disease with just a single risk factor," said Peter Lenehan, M.D., Ph.D. EGI's Chief Medical Officer. "In fact, it presents a high degree of variance at the molecular level that can significantly determine a patient's individual prognosis."

The company's portfolio is comprised of four unique companion diagnostics:

The human body is genetically equipped to ensure proper replication and repair of DNA, however the process can be imperfect, especially in patients with cancer. A mutation in the body's mismatch repair (MMR) system that normally helps correct improper DNA copying, can cause microsatellite instability (MSI), a condition in which replicated strands of DNA accumulate errors and become longer and shorter than they should be. People with MSI are more likely to suffer from errors in the repair and copying of their DNA.

MSI is an important consideration when determining which chemotherapy method will work best for a particular patient. Independent research shows that colon cancer patients with MSI may not benefit from, and might actually be harmed by, 5-FU therapy.These patients may be more responsive to irinotecan.On the other hand, colon cancer patients with correctly functioning microsatellites are likely to respond to and tolerate 5-FU therapy.

Research also suggests that patients with Lynch syndrome have defective DNA MMR systems. Physicians recommend that, given their increased risk for cancer, patients with the condition should be actively screened and often modify their lifestyles to prevent cancer. Doctors estimate that three out of every 100 colon cancers are caused by Lynch syndrome. Because Lynch syndrome is hereditary, active screening of family members of people who have the condition may also lead to early diagnosis and improved treatment planning.

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Everist Genomics Develops World's First Comprehensive Companion Diagnostics and Prognostics Portfolio for Early ...

12-03-2012 12:12 (Sonoran Living Advertiser) Envita Medical Centers Leaders in Cancer and Chronic Disease Personalized Medicine

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Envita Medical Centers offers personalized medicine - Video

08-03-2012 15:12 What is personalized medicine? Collaboration and leading-edge advancements in Greater Phoenix

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GPEC Personalized Medicine - Video

BETHLEHEM, Pa., March 12, 2012 /PRNewswire/ --Saladax Biomedical, Inc., a privately held company developing and commercializing novel diagnostic assays to achieve the promise of personalized medicine for new and existing therapeutics, announced today it has entered into a distribution agreement with INyDIA Labs, based in Madrid, Spain, for My5-FU, a test that measures levels of a widely-used anti-cancer drug, 5-fluorouracil (5-FU), in the blood of cancer patients.

"Our collaboration with INyDIA will allow us to provide cancer patients in Spain and Portugal more personalized treatment," said Adrienne Choma, Esq., Sr. VP and chief marketing officer of Saladax. "With this agreement, we expand availability of Saladax's My5-FU diagnostic assay in the global market."

INyDIA will be the exclusive provider of My5-FU test kits to laboratories in Spain and Portugal, enabling oncologists to individualize 5-FU dosing to optimize therapeutic efficacy and reduce toxicity for their patients.INyDIA, which specializes in producing in vitro diagnostic reagents and instrumentation, including array readers and liquid handling platforms, also offers its customers other manufacturers' products focused in personalized medicine.

"We're pleased to offer Saladax's unique technology to oncologists in Spain and Portugal to ensure personalized care is provided to their patient populations," said Santiago R. Maceira, country manager for INyDIA.

About My5-FUSaladax's first commercially available test for innovative dose management; My5-FU measures levels of 5-fluorouracil (5-FU), a widely used chemotherapy drug used in conjunction with other drugs in first-line therapy for colorectal cancer and other solid tumors. The assay technology enables oncologists to determine the optimal dose of 5-FU for each individual patient, thereby increasing the effectiveness of the drug and lessening the risk of severe toxicity and side effects.

About Saladax Biomedical, Inc.Saladax Biomedical develops and commercializes novel diagnostic assays to achieve the promise of personalized medicine through dose management and companion diagnostic products for existing and new therapeutics. The Company's dose management technology enables physicians to optimize drug dosing to meet individual patient needs, leading to improved response and quality of life. The Company's 15 MyCare dose management assays are comprised of proprietary, automated and cost-effective in vitro diagnostic tests, with a principal focus in oncology. The first MyCare assay available is for one of the most common anticancer drugs, 5-fluorouracil (5-FU). This assay is sold in the European Union by Saladax and its distribution partners as a CE-marked product and will be distributed in Japan by FALCO biosystems. In the United States and Canada, Myriad Genetic Laboratories, Inc. provides testing for 5-FU dose optimization under the trademark OnDose through a license to Saladax proprietary technology. Saladax also works with pharmaceutical companies to develop companion diagnostics to provide important clinical information to assist in developing and administering new and existing compounds. For more information, visit http://www.saladax.com.

My5-FU is a registered trademark of Saladax Biomedical, Inc. OnDose is a registered trademark of Myriad Genetics, Inc.

Saladax Biomedical, Inc. Adrienne Choma, Esq. Sr. VP & Chief Marketing Officer achoma@saladax.com

Media Contact:Tiberend Strategic Advisors, Inc.212-827-0020 Andrew Mielach amielach@tiberend.com or Jason Rando jrando@tiberend.com

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Saladax Biomedical, Inc. Expands Distribution of My5-FU in Spain and Portugal

LONDON--(BUSINESS WIRE)--

The world is currently witnessing a growing interest in both cost savings and greater safety and efficacy associated with a personalized medicine approach to drug therapies. Considerable gains will be realized if the right drug can be given to the right patient at the right dose, within any therapeutic area. Though the reimbursement, pricing, coding, and regulatory systems that will support this scientific and clinical paradigm shift are still evolving, slowly but there are real revenues being made and real potential for earnings. Forecasts say the market will approach USD37,480 million by 2016 globally.

New research study World Market for Personalized Medicine Diagnostics (Biomarkers, Pharmacodiagnostics, Tumor Assays, Cardiac Risk and Other Testing) worked out by Kalorama Information highlights the current opportunity and a realistic future potential for personalized medicine in clinical testing. Besides analyzing tests currently on the market and in development, it profiles key competitors and discusses trends important for understanding this growth area of the diagnostic industry. A special focus of the report is the bustle of activity with collaborations between IVD and pharmaceutical companies, as well as IVD companies and CLIA labs.

Biomarkers discussed in the report include: Cytochrome P450 and Drug Metabolism, Estrogen Receptor and Progesterone, Receptor Status for Breast Cancer, HER2 Overexpression and Herceptin and Tykerb, Epidermal Growth Factor Receptor (EGFR), KRAS Mutations and Anti-EGFR Therapy for Colorectal Cancer, BRAF Mutations and Cancer Therapy, UGT1A1 Genetic Variants, 5-Flurouracil Therapy, PIK3CA Genetic Variation, KIF6 Genetic Variation, ALK Genetic Variation.

Report Details:

Title: World Market for Personalized Medicine Diagnostics (Biomarkers, Pharmacodiagnostics, Tumor Assays, Cardiac Risk and Other Testing)

Published: March, 2011

Pages: 430

Price: US$ 3,795

http://marketpublishers.com/report/medicine_pharmaceuticals_biotechnology/drugs_biotechnology/world_market_4_personalized_medicine_diagnostics_biomarkers_pharmacodiagnostics_tumor_assays_cardiac_risk_n_other_testing.html

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Global Personalized Medicine Diagnostics Market Analyzed in New Study Now Available at MarketPublishers.com

06-03-2012 19:59 Visit http://www.pmwcintl.com for more info

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Brett Davis: Personalized Medicine: Humanity's Ultimate Big Data Challenge - Video

06-03-2012 18:12 Visit http://www.pmwcintl.com for more info

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Alexis Borisy: Personalized Medicine Here and Now - Video

PARIS--(BUSINESS WIRE)--

The upcoming annual symposium of the Worldwide Innovative Networking Consortium on personalized cancer medicine (WIN 2012), to be held in Paris, June 28-29, 2012, has received endorsements from the American Society of Clinical Oncology (ASCO), the European Society for Medical Oncology (ESMO), the Union for International Cancer Control (UICC) and also the French national cancer institute (INCa).

"The value of the symposium scientific program for the oncology community is reinforced by these recently granted endorsements" said Dr. John Mendelsohn, Chairman of the WIN Consortium.

"These endorsements acknowledge this unique forum for open discussion in which the expertise and input from all stakeholders in targeted cancer drug development are crucial" said Alexander Eggermont, General Director of Cancer Institute Gustave Roussy.

High-ranking speakers from academia, industry and regulatory agencies worldwide will address ways to improve the efficacy of cancer therapeutics at the level of the individual patient in plenary sessions on contemporary themes in personalized medicine. Speakers include: James Doroshow, National Cancer Institute; Ronald DePinho, University of Texas MD Anderson Cancer Center; William Dalton, Lee Moffitt Cancer Center; Edison Liu, Human Genome Organisation HUGO and Jackson Laboratory; Christopher A. Viehbacher, Sanofi; Leroy Hood, Institute for Systems Biology; Stephen Friend, Sage Bionetworks; John Quackenbush, Dana-Farber Cancer Institute; Waun Ki Hong, University of Texas MD Anderson Cancer Center; Nick Botwood, AstraZeneca; Steven Averbuch, Bristol-Myers Squibb; Richard Gaynor, Eli Lilly and Company; Paolo Paoletti, GlaxoSmithKline Oncology; Josep Tabernero, Val dHebron.

The scientific program of WIN2012 is offered as accredited learning for medical oncologists, valid for 17 ESMO MORA cat. 1 points. To further enhance the scientific value of WIN 2012, all abstracts of presentations (oral and poster) will be published in a major international oncology journal. Abstract submission remains open until April 1.

Delegates considering participating in WIN 2012 are encouraged to register as soon as possible to take advantage of the significantly reduced early registration fees and the special hotel offer the WIN 2012 organizers have managed to secure.

Extensive symposium information, including the complete program with all speakers names, is available on the website of WIN Consortium: http://www.winconsortium.org.

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WIN2012 Symposium on Personalized Cancer Medicine Receives Endorsements from ASCO, ESMO, UICC and INCa

This post is sponsored by BioNJ.

BioNJ, the trade association for New Jerseys biotechnology industry, will host its biggest and most interactive event to date for companies involved in diagnostics and personalized medicine on March 14 at Princeton University. The BioNJ Diagnostics & Personalized Medicine Innovation Summit and Funding Roundtable, part of BioNJs ongoing Diagnostics & Personalized Medicine Initiative, will bring together leaders from major global biotechnology and pharmaceutical companies, diagnostics companies and emerging innovator companies for a half-day, interactive summit meeting.

The focus of this half-day summit is to help participants identify opportunities for partnership, funding and growth while updating them on the latest trends, developments and challenges in the evolution and adoption of personalized medicine. All companies and individuals with an interest in diagnostics and personalized medicine are welcome to attend. The Summit will include company presentations and opportunities for one-on-one communication and interaction between leading global pharmaceutical companies, emerging diagnostics companies, funding organizations and life sciences company business development professionals.

This event promises to be truly unique for those who attend, said Debbie Hart, President of BioNJ. Not only have we confirmed first-class speakers from all key constituencies involved with diagnostics and personalized medicine, we will also create opportunities for global life science leaders, smaller innovators and members of the investment community to network and establish partnerships that will advance the development and utilization of personalized medicine worldwide.

Speaking at the Summit will be leaders from the global investment community, global life sciences companies and academia:

The BioNJ Diagnostics and Personalized Medicine Committee, which created the event, is planning additional events focusing on diagnostics and personalized medicine, and will announce details for future events on its website.

The increasing interest in diagnostics and personalized medicine, and its potential to transform medicine, is clear from the participation in the events that the BioNJ Diagnostics and Personalized Medicine Committee has offered so far, said Steve Carchedi, Committee Co-Chair, Chief Marketing Officer, Medical Diagnostics, GE Healthcare. The BioNJ Diagnostics & Personalized Medicine Innovation Summit and Funding Roundtable will be our biggest event ever, and I encourage anyone with an interest in diagnostics and personalized medicine to join us on March 14th at Princeton University, he added.

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BioNJ Diagnostics & Personalized Medicine Innovation Summit is March 14

NEW YORK, NY--(Marketwire -03/07/12)- Led by tissue tests to aid drug therapy decisions, the personalized medicine testing (PMx) market exceeded $28 billion in 2011, according to Kalorama Information. The healthcare market research publisher includes in its analysis all tests that are used to determine the appropriate therapeutic on an individual patient. This broad scope includes new molecular tests based on proven biomarkers, as well as routine glucose and microbial identification tests. The dynamic part of the market is the new tests, and according to Kalorama's report, World Market for Personalized Medicine Diagnostics, the tests that have turned personalized medicine from concept to reality are tissue tests that determine therapy for cancer. These will experience better than average IVD industry revenue growth rates in the next five years.

"Tissue-based diagnostic testing continues to serve as one of the gold standards for cancer diagnosis," said Shara Rosen, lead diagnostic analyst for Kalorama Information and author of the report. "There is no other technology that can capture the biological context of the disease and the critical parameters that factor into patient outcomes."

From a biopsy, a pathologist can determine the type of cancer, the stage, and the degree to which the cancer has invaded healthy tissue. Personalized tissue-based tests using immunohistochemical stains (IHC) and in situ hybridization (ISH) allow pathologists and researchers to view specific protein and molecular structures in fixed tissues, body fluids, and cells. To improve patient survival rates, therapies in the oncology marketplace are being combined with predictive biomarkers to help select patients who will respond to specific drugs. The report finds that tissue diagnostics will be in high demand and produce a robust market with many high growth opportunities.

Kalorama reports that the market leaders in what is often called pharmacodiagnostic histology are Dako, Abbott Diagnostics and Roche/Ventana Medical. China Medical is dedicated to making locally produced pharmacodiagnostic histology available.

The report notes that the application of pharmacodiagnostic histology is becoming more sophisticated. Many of these tests are used as companion tests for targeted drugs and also in test services. In addition to the standard IHC and ISH staining procedures, DNA and RNA extracted from tissue samples are further analyzed using mass spectroscopy, PCR and sequencing. As more is understood about radiation therapy, tests have also been developed to assess radiosensitivity of tumors.

Kalorama Information's report, World Market for Personalized Medicine Diagnostics, covers these tests and many others, while defining the current opportunity and realistic future potential of personalized medicine in clinical testing.

About Kalorama InformationKalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog.

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Tissue Diagnostics Leads Personalized Medicine: Kalorama