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ATOSSA GENETICS, INC. SHAREHOLDER ALERT: Levi & Korsinsky, LLP Announces Class Action Against Atossa Genetics, Inc …

NEW YORK, Oct. 14, 2013 (GLOBE NEWSWIRE) -- Levi & Korsinsky announces that a class action lawsuit has been commenced in the United States District Court for the Western District of Washington on behalf of investors who purchased Atossa Genetics, Inc. ("Atossa" or the "Company") (ATOS) stock between November 8, 2012 and October 4, 2013.

For more information, click here: http://zlk.9nl.com/atossa-genetics-atos.

The Complaint alleges that throughout the Class Period defendants made false and misleading statements and/or failed to disclose the following: a) that the Company failed to submit an additional 510(k) notification to obtain necessary FDA clearance as it made material changes to the Nipple Aspirate Fluid specimen collection process; b) that the Company improperly marketed its device by using certain promotional claims to market its ForeCYTE Breast Health Test and the MASCT device; and c) that the Company was in violation of FDA Good Manufacturing Practices regulations.

On October 4, 2013, Atossa announced a voluntary recall of its ForeCYTE Test, including a recall of the MASCT System Kit and Patient Sample Kit. The recall commenced to address concerns raised in a February 2013 warning letter issued by the U.S. Food and Drug Administration.

If you suffered a loss in Atossa you have until December 9, 2013 to request that the Court appoint you as lead plaintiff. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. To obtain additional information, contact Joseph E. Levi, Esq. either via email at jlevi@zlk.com or by telephone at (212) 363-7500, toll-free: (877) 363-5972, or visit http://zlk.9nl.com/atossa-genetics-atos.

Levi & Korsinsky is a national firm with offices in New York, New Jersey, Connecticut, and Washington D.C. The firm has extensive expertise in prosecuting securities litigation involving financial fraud, representing investors throughout the nation in securities and shareholder lawsuits. Attorney advertising. Prior results do not guarantee similar outcomes.

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ATOSSA GENETICS, INC. SHAREHOLDER ALERT: Levi & Korsinsky, LLP Announces Class Action Against Atossa Genetics, Inc ...

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Stem Cell Therapy Process: Murphy the Irish Wolfhound – Video


Stem Cell Therapy Process: Murphy the Irish Wolfhound
Murphy is a 6 year old Irish Wolfhound who is both a service dog and a therapy dog. When he tore his ACL and then fell and fractured his pelvis, we had only ...

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Stem Cell Therapy in India for Osteoarthritis – Video


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Mathew Blurton Jones – New Hope: Stem Cell Therapy in Alzheimer’s Disease – Video


Mathew Blurton Jones - New Hope: Stem Cell Therapy in Alzheimer #39;s Disease
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In a surprise finding, gene mutation found linked to low-risk bladder cancer

Public release date: 13-Oct-2013 [ | E-mail | Share ]

Contact: Karen Mallet km463@georgetown.edu Georgetown University Medical Center

WASHINGTON An international research team led by scientists from Georgetown Lombardi Comprehensive Cancer Center has discovered a genetic mutation linked to low-risk bladder cancer. Their findings are reported online today in Nature Genetics.

The investigators identified STAG2 as one of the most commonly mutated genes in bladder cancer, particularly in tumors that do not spread. The finding suggests that checking the status of the gene may help identify patients who might do unusually well following cancer treatment, says the study's senior investigator, cancer geneticist Todd Waldman, MD, PhD, a professor of oncology at Georgetown Lombardi.

"Most bladder cancers are superficial tumors that have not spread to other parts of the body, and can therefore be easily treated and cured. However, a small fraction of these superficial tumors will recur and metastasize even after treatment," he says.

Because clinicians have been unable to definitively identify those potentially lethal cancers, all bladder cancers patients after surgery to remove tumors must undergo frequent endoscopic examinations of their bladder to look for signs of recurrence, says Waldman. This procedure, called cystoscopy, can be uncomfortable and is expensive.

"Our data show that STAG2 is one of the earliest initiating gene mutations in 30-40 percent of superficial or 'papillary-type' bladder tumors, and that these tumors are unlikely to recur," says David Solomon, MD, PhD, a lead author on the study. Solomon is a graduate of the Georgetown MD/PhD program and is currently a pathology resident at the University of California, San Francisco.

"We have developed a simple test for pathologists to easily assess the STAG2 status of these tumors, and are currently performing a larger study to determine if this test should enter routine clinical use for predicting the likelihood that a superficial bladder cancer will recur," Solomon says.

For the study, the researchers examined 2,214 human tumors from virtually all sites of the human body for STAG2 inactivation and found that STAG2 was most commonly inactivated in bladder cancer, the fifth most common human cancer. In follow up work, they found that 36 percent of low risk bladder cancers those that never invaded the bladder muscle or progressed had mutated STAG2. That suggests that testing the STAG2 status of the cancer could help guide clinical care, Waldman says. "A positive STAG2 mutation could mean that patient is at lower risk of recurrence."

The researchers also found that 16 percent of the bladder cancers that did spread, or metastasize, had mutated STAG2.

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Genetic Engineering and Islam – Video


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Myriad's myPath(TM) Melanoma Test is Highly Effective in Verification Study

SALT LAKE CITY, Oct. 14, 2013 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN) today announced that results from a verification study showed the Myriad myPath(TM) Melanoma test effectively differentiated malignant melanoma from benign skin lesions. The clinically-actionable information provided by myPath Melanoma will empower healthcare providers with objective data and improve the diagnosis of patients with melanoma. Myriad presented these data at the American Society of Dermatopathology Annual Meeting on Oct. 13, 2013.

The verification study evaluated a 23-gene panel designed to differentiate malignant melanoma from benign skin lesions. The study analyzed 464 skin biopsy samples including 254 samples representing melanomas from all major subtypes including superficial spreading, lentigo maligna melanoma, acral, nodular and desmoplastic lesions. Using this set of patient samples, the myPath Melanoma test demonstrated high sensitivity of 89 percent and specificity of 93 percent at differentiating malignant melanoma from benign skin lesions.

"The data from this large cohort showed that this test is highly accurate, relative to expert dermatopathologic review, at differentiating malignant melanoma from benign skin lesions," said Sancy Leachman, M.D., Ph.D, chair of the Department of Dermatology in the Oregon Health & Science University (OHSU) School of Medicine and director of the Melanoma Research Program at the Knight Cancer Institute. "The diagnosis of melanoma by conventional methods often is subjective, and this test provides objective data which could make it an extremely valuable and useful diagnostic tool to help save patients' lives."

Melanoma is the most serious type of skin cancer. According to the American Cancer Society statistics, about 76,000 new melanomas are diagnosed each year, and more than 9,000 people die from melanoma annually. Each year in the United States, there are approximately two million skin biopsies performed specifically for the diagnosis of melanoma. Approximately 14 percent or 280,000 biopsies are classified as indeterminate, which means the dermatopathologist cannot confidently determine whether the cells are benign or malignant.

"Patients and physicians with an indeterminate biopsy result face the challenging clinical question of whether to treat the lesion as melanoma or risk not treating a potentially fatal cancer," Loren Clarke, M.D., vice president of Medical Affairs of Dermatology at Myriad. "Late-stage melanoma has a five-year survival rate of 15 percent compared to early-stage melanomas that have five-year survival rates of about 90 percent. The ability to accurately diagnose and treat melanoma early on is critical to obtaining favorable long-term clinical outcomes."

About Myriad Genetics

Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad's portfolio of molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company's website at: http://www.myriad.com and our social media channels: Twitter and Facebook.

Myriad, the Myriad logo and myPath are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and other countries. MYGN-F, MYGN-G

Safe Harbor Statement

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to myPath Melanoma providing clinically-actionable information that will empower healthcare providers with objective data and improve the diagnosis of patients with melanoma; myPath Melanoma providing objective data which could make it an extremely valuable and useful diagnostic tool to help save patients' lives; and the Company's strategic directives under the caption "About Myriad Genetics". These "forward-looking statements" are management's present expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and companion diagnostic services may decline or will not continue to increase at historical rates; risks related to changes in the governmental or private insurers reimbursement levels for our tests; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and companion diagnostic services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to increased competition and the development of new competing tests and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and companion diagnostic services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

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Myriad's myPath(TM) Melanoma Test is Highly Effective in Verification Study

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Gregory L. Weaver Joins Atossa Genetics' Board of Directors

SEATTLE, WA--(Marketwired - Oct 14, 2013) - Atossa Genetics Inc. (NASDAQ: ATOS), The Breast Health Company, announced today that Gregory L. Weaver has joined the Company's Board of Directors and has been appointed a member of the Audit Committee.

"Greg brings a wealth of financial and operational experience in the Life Sciences industry to Atossa's Board of Directors and Audit Committee, including mergers and acquisitions, licensing transactions, regulatory approvals, and new product launches, as well as strategic planning and cost control efforts," said Steven C. Quay, Chairman, President & CEO. "Greg's experience will be invaluable to the Board and to management as we continue to build the Company."

Weaver has built a successful career in executive financial and operations management serving as CFO of small to mid-cap public and private biotechnology companies. He currently serves as Chief Financial Officer, Senior Vice President, Treasurer and Corporate Secretary of Fibrocell Science, Inc. Prior to joining Fibrocell Science in September 2013, he served as CFO with the following public companies: Celsion Corp., Poniard Pharmaceuticals, Sirna Therapeutics (acquired by Merck), Nastech Pharmaceuticals, and ILEX Oncology (acquired by Genzyme), and venture funded firms Talyst, Inc. and Prism Technologies. In addition, Greg served as a director and audit committee chairman of Celsion from 2005-2011, as a director with the Washington State WBBA, and has consulted with other biotech companies throughout his career. Greg began his career as a Certified Public Accountant with Arthur Andersen. He has a Master of Business Administration from Boston College and Bachelor of Science from Trinity University.

"I appreciate the opportunity to join the Board of Directors of Atossa Genetics at this important juncture," commented Weaver. "Atossa has the potential to make a significant contribution toward women's breast health and I look forward to the future success of the Company."

About Atossa Genetics, Inc.

Atossa Genetics, Inc. is focused on the commercialization of patented, diagnostic medical devices and, through its wholly-owned subsidiary, The National Reference Laboratory for Breast Health, Inc. (NRLBH), patented, laboratory developed tests. The NRLBH is a CLIA-certified high-complexity molecular diagnostic laboratory located in Seattle, Washington.

For additional information please visit http://www.atossagenetics.com.

Forward-Looking Statements

Forward-looking statements in this Press Release are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with actions by the FDA, the outcome or timing of regulatory clearances needed by Atossa to sell its products, responses to regulatory matters, Atossa's ability to continue to manufacture and sell its products, recalls of products, the efficacy of Atossa's products and services, the market demand for and acceptance of Atossa's products and services, performance of distributors, estimated future expenses and cash needs, and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

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Gregory L. Weaver Joins Atossa Genetics' Board of Directors

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Sleep-Related Breathing Disorders in Spinal Cord Injury – Video


Sleep-Related Breathing Disorders in Spinal Cord Injury
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Panama before last stem cell therapy treatment – Video


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Stem Cell therapy in India for ischemic heart disease (ISD) – Video


Stem Cell therapy in India for ischemic heart disease (ISD)
ISD can be treated with stem cell therapy at StemRx Bioscience Solutions. In case of above patient we have seen drastic improvement is heart functioning.

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The Genetics of Warfarin (Coumadin) Response – Video


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Dr. Sondak on Personalized Medicine in Melanoma – Video


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Stem cell therapy in India for Avascular Necrosis (AVN) – Video


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Avascular necrosis can be completely treated with stem cell therapy. Stem cell therapy provided at StemRx Bioscience solutions is strong alternative option f...

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The Cure is Coming – Jamie Cottie – GE FOCUS FORWARD – Video


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ACGT Presents ‘Achieving Cancer Remission with Cell and Gene Therapies’

New York, NY and Stamford, CT (PRWEB) October 11, 2013

Alliance for Cancer Gene Therapy (ACGT), a not-for-profit dedicated exclusively to funding research for cancer treatments using cell and gene therapies, will host Achieving Cancer Remission with Cell and Gene Therapies on Tuesday, October 15 at the Harvard Club of New York City, 35 W. 44th Street. ACGT is renowned for devoting 100-percent of funds raised directly to research, and for uniting top scientific minds to explore innovative treatments that target only the cancer.

Featuring a panel of esteemed ACGT research fellows and award-winning doctors from the nations top medical institutions, the evening will focus on the extraordinary potential of cell- and gene-based therapies to provide swift and safe treatment of all types of cancer.

Our October event will bring together top cancer researchers in the cell and gene therapy field, and showcase the remarkable promise of the treatments, said Barbara Netter, co-founder of the Stamford, CT-based ACGT. Mrs. Netter and her husband Edward created the non-profit in 2001, shortly after losing their daughter-in-law to breast cancer.

The panel will be hosted by Dr. Savio L.C. Woo, chairman of the ACGT Scientific Advisory Council and Professor and Founding Chairman of the Department of Gene and Cell Medicine at Mt. Sinai School of Medicine in New York. Dr. Woo has served as chairman for a slate of non-profit gene therapy organizations and been awarded a suite of prestigious awards for his research. Dr. Woo along with Dr. Michael Lotze of the University of Pittsburgh introduced Edward and Barbara Netter to the possibilities of gene and cell therapy over one decade ago.

The evening will begin with a reception at 6:30 p.m., followed by a salutation by Dr. Savio Woo at 7:15 p.m. The presentation will start at 7:30 p.m., and culminate with a question and answer session at 8:30 p.m.

Panel members include:

(For further information on the evenings panelists, please see bios at the end of the release.)

The presentation Achieving Cancer Remission with Cell and Gene Therapies is free and open to the public, although reservations are limited. For additional information or to make a reservation, contact Betty Condon at 203.358.8000, ext. 497 or bcondon(at)acgtfoundation(dot)org.

ACGT is located at 96 Cummings Point Road, Stamford, CT 06902.

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ACGT Presents ‘Achieving Cancer Remission with Cell and Gene Therapies’

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Newly discovered gene regulator could precisely target sickle cell disease

Oct. 10, 2013 A research team from Dana-Farber/Boston Children's Cancer and Blood Disorders Center and other institutions has discovered a new genetic target for potential therapy of sickle cell disease (SCD). The target, called an enhancer, controls a molecular switch in red blood cells called BCL11A that, in turn, regulates hemoglobin production.

The researchers -- led by Daniel Bauer, MD, PhD, and Stuart Orkin, MD, of Dana-Farber/Boston Children's -- reported their findings today in Science.

Prior work by Orkin and others has shown that when flipped off, BCL11A causes red blood cells to produce fetal hemoglobin that, in SCD patients, is unaffected by the sickle cell mutation and counteracts the deleterious effects of sickle hemoglobin. BCL11A is thus an attractive target for treating SCD.

The disease affects roughly 90,000 to 100,000 people in the United States and millions worldwide.

However, BCL11A plays important roles in other cell types, including the immune system's antibody-producing B cells, which raises concerns that targeting it directly in sickle cell patients could have unwanted consequences.

The discovery of this enhancer -- which regulates BCL11A only in red blood cells -- opens the door to targeting BCL11A in a more precise manner. Approaches that disable the enhancer would have the same end result of turning on fetal hemoglobin in red blood cells due to loss of BCL11A, but without off-target effects in other cell types.

The findings were spurred by the observation that some patients with SCD spontaneously produce higher levels of fetal hemoglobin and enjoy an improved prognosis. The researchers found that these individuals possess naturally occurring beneficial mutations that function to weaken the enhancer, turning BCL11A's activity down and allowing red blood cells to manufacture some fetal hemoglobin.

"This finding gives us a very specific target for sickle cell disease therapies," said Orkin, a leader of Dana-Farber/Boston Children's who serves as chairman of pediatric oncology at Dana-Farber Cancer Institute and associate chief of hematology/oncology at Boston Children's Hospital. "Coupled with recent advances in technologies for gene engineering in intact cells, it could lead to powerful ways of manipulating hemoglobin production and new treatment options for hemoglobin diseases."

"This is a very exciting study," said Feng Zhang, PhD, a molecular biologist and specialist in genome engineering at the McGovern Institute for Brain Research at the Massachusetts Institute of Technology (MIT) and the Broad Institute of MIT and Harvard, who was not involved in the study. "The findings suggest a potential new approach to treating sickle cell disease and related diseases, one that relies on nucleases to remove this regulatory region, rather than adding an exogenous gene as in classic gene therapy."

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Newly discovered gene regulator could precisely target sickle cell disease

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Gene Variant That Boosts UV Protection Also Raises Risk For Cancer

"The genetic risk factor we identified is associated with one of the largest risks ever reported for cancer," author Douglas Bell, a researcher at the National Institute of Environmental Health Sciences at the National Institutes of Health, said in a statement. (Bell is currently on furlough thanks to the federal government shutdown and could not discuss his research in an interview.)

Bell and his colleagues reported their find in the journal Cell on Thursday.

"We think it might prove useful for identifying individuals at the highest risk for cancer or who might benefit from preventive or therapeutic treatments, Bell says.

The gene in question is a binding site made for a protein called p53, which is an important genetic master switch, binding to DNA and regulating the cell division cycle and suppressing tumors when it works properly, that is. Mutations in p53 are implicated in a wide range of cancers, so Bell and his colleagues were interested in examining mutations in other parts of the p53 signaling chain.

Bell and his team were led to this particular mutation by what are called genome-wide association studies. In these kinds of studies, scientists compare the genomes of people with a certain trait, like cancer, to the genomes of people without the trait. If they see that a certain gene tends to crop up more often amongst the people with the trait, they may says the gene is associated with that trait.

In this study, the researchers zoomed in on a p53-binding region in a gene called KITLG. When UV radiation hits a persons skin, it induces a signaling chain involving both the KITLG gene and p53, eventually marshaling the melanin-producing cells that trigger a tanning response. KITLG activation by p53 also turns out to be important for cancer-related cell proliferation.

Normally, evolution might be expected to weed out the p53 binding site mutation, but in this case, in lighter-skinned people the protection from UV radiation proved more urgent a need than cutting cancer risk down the line. Its not uncommon in nature to see some trade-offs that boosts short-term survival or reproductive ability in exchange for reduced fitness down the line.

"It seems that over the long course of human evolution, the trade-off might have worked well enough to boost the frequency of the [mutation], especially in the European Caucasian population," coauthor and University of Oxford researcher Gareth Bond said in a statement. "I'd speculate that serious sun damage to skin would have posed a mortal threat to our early ancestors."

SOURCE: Zeron-Medina et al. A Polymorphic p53 Response Element in KIT Ligand Influences Cancer Risk and Has Undergone Natural Selection. Cell 155: 410 422, 10 October 2013.

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Transgenics – Genetic Engineering in Geek Fiction: Kiriosity with Kiri Callaghan – Video


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Genetic Variant Increases Testicular Cancer Risk Also Evolved To Protect Light Skin

October 11, 2013

Brett Smith for redOrbit.com Your Universe Online

Using a genomic analysis, a team of international researchers has identified a specific mutation responsible for a dramatic increase in the risk for testicular cancer.

The mutation is a single-base change to the genetic code that affects the activity of the p53 protein that is responsible for regulating the activity of a large number of genes, including those responsible for protection from UV rays according to the teams report in the journal Cell.

Knowing the inherited genetics of cancer has great potential in medicine, said study author Gareth Bond, a researcher at Oxford Universitys Ludwig Institute for Cancer Research. It can aid the development of tests to predict the risk of developing particular malignancies. It can also tell physicians about the likely prognosis of cancers, and inform therapeutic choices, improving management of the disease.

About half of all cancers are affiliated with mutations in the p53 gene. Because the p53 protein activates a wide range of cancer-related signaling pathways, the study team hypothesized that cancer risk could be linked to genetic variations for p53-binding sites.

The single-based change, known as a single nucleotide polymorphism (SNP), was discovered after the team analyzed genetic databases containing nearly 63,000 SNPs in search of mutations that affect p53s ability to turn on its target genes. The researchers were able to find one particular mutation that is very strongly linked to the risk of developing testicular cancer.

The SNP was found in the genetic code for a p53 response element that codes for a protein named KIT ligand (KITLG).

It appears that this particular variant permits testicular stem cells to grow in the presence of DNA damage, when they are supposed to stop growing, since such damage can lead to cancer, said study author Douglas Bell of the US National Institute of Environmental Health Sciences.

Next, the team performed an evolutionary genomic analysis that revealed that other SNPs that alter p53s ability to bind its receptors have been lost by natural selection. The KITLG mutation not only slipped through the cracks, it has been positively selected in the Caucasian gene pool.

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CellScape to Sponsor Educational Workshop at National Society of Genetic Counselors' Annual Education Conference

NEWARK, Calif., Oct. 10, 2013 (GLOBE NEWSWIRE) -- CellScape Corp, a molecular diagnostics company developing the first noninvasive prenatal genetic test using fetal cells from maternal blood, today announced that it is supporting a workshop with leading experts in the field of prenatal testing at the upcoming National Society of Genetic Counselors (NSGC) 32nd Annual Education Conference (AEC). The session, "Comprehensive Prenatal Genetic Testing: Is Chromosomal Microarray Analysis the New Standard?", will take place Friday, October 11, 2013 at 7:00 AM PT at the Anaheim Convention Center in Anaheim, California.

"Options for prenatal diagnostic testing continue to evolve as new technologies including chromosomal microarray analysis (CMA) become available. A recent study supported by the National Institute of Child Health and Human Development (NICHD) has validated the utility of CMA in providing more information than the current standard of karyotype analysis," said Ted Snelgrove, Chief Executive Officer, CellScape. "In response to needs expressed by genetic counselors, we are pleased to support this educational session to examine the benefits and challenges of implementing CMA as a prenatal test."

The speakers scheduled to participate include Mary Norton, MD, FACMG, FACOG, Professor and Vice Chair for Clinical and Translational Genetics in the Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco; Christa Lese Martin, PhD, FACMG, Director and Senior Investigator, Autism and Developmental Medicine Institute at Geisinger Health System; and Andy Faucett, MS, CGC, Director of Policy and Education for the Office of the Chief Scientific Officer at Geisinger Health System.

Dr. Norton will provide an overview of the recent changes in both invasive and noninvasive prenatal testing and will review the impact on clinical care resulting from the additional information provided by chromosomal microarray analysis.

Dr. Martin, co-author of the recent landmark NICHD study published in 2012 will review the study's findings that showed that chromosomal microarray analysis has a higher diagnostic yield than karyotyping for prenatal diagnosis. Lastly, Mr. Faucett, an experienced board-certified genetic counselor will outline the key issues and concerns in counseling for prenatal arrays.

About the National Society of Genetic Counselors (NSGC)

NSGC is the leading voice, authority and advocate for the genetic counseling profession, representing more than 2,900 health professionals. The organization is committed to ensuring that the public has access to genetic counseling and genetic testing. For more information, visit http://www.nsgc.org.

NSGC's AEC provides the latest information for the genetic counseling profession and addresses a wide variety of practice areas with diverse education sessions specifically designed for genetic counselors and genetic professionals.

About CellScape Corporation

CellScape Corporation is an innovative molecular diagnostics company developing a more comprehensive and safe prenatal testing solution for women. CellScape's proprietary Fetal Cell Technology enables it to isolate fetal cells specific to a woman's current pregnancy from a simple maternal blood draw. By isolating these cells, CellScape can access the pure and complete fetal genome. CellScape's first product in development, Clarity(TM) Prenatal Genetic test, will use targeted Chromosomal Microarray Analysis (CMA) to detect prenatally relevant cytogenetic abnormalities. For additional information, please visit http://www.cellscapecorp.com.

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CellScape to Sponsor Educational Workshop at National Society of Genetic Counselors' Annual Education Conference

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The Genetics of Thiopurine Response – Video


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Seattle Genetics Reports ADCETRIS Data In Frontline Setting On Hodgkin Lymphoma

By RTT News, October 11, 2013, 09:12:00 AM EDT

(RTTNews.com) - Seattle Genetics Inc. ( SGEN ) highlighted multiple ADCETRIS data presentations at the 9th International Symposium on Hodgkin Lymphoma or ISHL being held October 12-15, 2013 in Cologne, Germany.

ADCETRIS, an antibody-drug conjugate directed to CD30, which is expressed in classical Hodgkin lymphoma or HL and systemic anaplastic large cell lymphoma or sALCL, was granted accelerated approval by the U.S. Food and Drug Administration or FDA in August 2011 for relapsed HL and sALCL and conditional marketing authorization by the European Commission in October 2012 for relapsed or refractory HL and sALCL.

Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics said, "In addition, we are evaluating ADCETRIS broadly in more than 20 ongoing clinical trials, including four global phase 3 trials in earlier lines of therapy for HL and mature T-cell lymphoma, as well as relapsed cutaneous T-cell lymphoma. Our goal is to establish ADCETRIS as the foundation of therapy for CD30-positive malignancies and improve the therapeutic outcome for patients."

Three oral and nine poster presentations at ISHL illustrate the broad clinical development program for ADCETRIS in HL, including data from a phase 1 frontline advanced HL trial and a poster presentation describing the ongoing global phase 3 ECHELON-1 clinical trial in frontline HL. Currently, ADCETRIS is not approved to treat newly diagnosed HL.

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Seattle Genetics Highlights ADCETRIS® (Brentuximab Vedotin) Clinical Data in the Frontline Setting at the …

BOTHELL, Wash.--(BUSINESS WIRE)--

Seattle Genetics, Inc. (SGEN) today highlighted multiple ADCETRIS (brentuximab vedotin) data presentations at the 9th International Symposium on Hodgkin Lymphoma (ISHL) being held October 12-15, 2013 in Cologne, Germany. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed in classical Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). ADCETRIS was granted accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2011 for relapsed HL and sALCL and conditional marketing authorization by the European Commission in October 2012 for relapsed or refractory HL and sALCL.

Since the last ISHL meeting in 2010, we have made significant progress in advancing ADCETRIS, including approvals in 35 countries to date for the treatment of relapsed HL and sALCL, said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. In addition, we are evaluating ADCETRIS broadly in more than 20 ongoing clinical trials, including four global phase 3 trials in earlier lines of therapy for HL and mature T-cell lymphoma, as well as relapsed cutaneous T-cell lymphoma. Our goal is to establish ADCETRIS as the foundation of therapy for CD30-positive malignancies and improve the therapeutic outcome for patients.

Three oral and nine poster presentations at ISHL illustrate the broad clinical development program for ADCETRIS in HL, including data from a phase 1 frontline advanced HL trial and a poster presentation describing the ongoing global phase 3 ECHELON-1 clinical trial in frontline HL. ADCETRIS is currently not approved for use in the treatment of newly diagnosed HL.

Frontline HL Data Presentations: Corporate-sponsored Trials

Frontline Therapy with Brentuximab Vedotin Combined with ABVD or AVD in Patients with Newly Diagnosed Advanced Stage Hodgkin Lymphoma, (P005) by Dr. Stephen Ansell, Professor of Medicine, Division of Hematology, Mayo Clinic

This phase 1 trial was conducted to evaluate ADCETRIS plus the chemotherapy regimen ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) or ADCETRIS plus AVD, which removes bleomycin, for the treatment of newly diagnosed advanced stage HL patients.

After completing a combination regimen of ADCETRIS plus AVD, 24 of 25 patients (96 percent) achieved a complete remission. Among the patients in the ADCETRIS plus ABVD cohorts, 21 of 22 patients (95 percent) who completed frontline therapy on study achieved a complete remission. The most common adverse events of any grade occurring in more than 30 percent of patients across both treatment regimens were hair loss, constipation, diarrhea, fatigue, insomnia, nausea, neutropenia, peripheral sensory neuropathy, fever and vomiting. As previously reported, pulmonary toxicity was seen in the ADCETRIS plus ABVD cohorts, resulting in a contraindication for the concomitant administration of ADCETRIS and bleomycin. No pulmonary toxicity was observed in the ADCETRIS plus AVD cohort.

These data support the enrollment of the ongoing global phase 3 ECHELON-1 trial. The design of the phase 3 trial will be described in a presentation at ISHL, titled Phase 3 Study of Brentuximab Vedotin Plus Doxorubicin, Vinblastine and Dacarbazine (A+AVD) vs Doxorubicin, Bleomycin, Vinblastine and Dacarbazine (ABVD) as Front-line Treatment for Advanced Classical Hodgkin Lymphoma (HL): The ECHELON-1 Study, (P017) by Dr. John Radford, Professor of Medical Oncology, University of Manchester. Visit http://www.clinicaltrials.org for more information about ECHELON-1.

Frontline HL Data Presentations: Investigator-sponsored Trials

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Seattle Genetics Highlights ADCETRIS® (Brentuximab Vedotin) Clinical Data in the Frontline Setting at the ...

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