Archive for the ‘Gene Therapy Research’ Category

AMES, IA--(Marketwired - May 16, 2013) - NewLink Genetics Corporation (NASDAQ: NLNK), an oncology-focused biopharmaceutical company specializing in immunotherapy, today announced that several clinical presentations on its two proprietary platform technologies have been selected for the upcoming 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO). The meeting will be held May 31 to June 4, 2013 in Chicago, IL. NewLink's HyperAcute technology will be featured in one oral presentation on the company's most advanced drug candidate, algenpantucel-L, in pancreatic cancer, and in one poster presentation on tergenpumatucel-L in non-small cell lung cancer (NSCLC). The company's lead small molecule drug candidate, indoximod, which targets the IDO pathway will be highlighted in one poster discussion and one poster presentation involving patients with metastatic solid tumors.

"These clinical presentations describe the potential benefits generated from NewLink's two proprietary immunotherapy platforms: HyperAcute technology products stimulate the human immune system to recognize and attack cancer cells while our IDO pathway products break down the defense mechanisms of cancer cells," commented Charles Link, Jr., MD, Chairman and Chief Executive Officer of NewLink.

Oral Presentation:

Poster Discussion:

Poster Presentations:

About HyperAcute Immunotherapy

NewLink's HyperAcute immunotherapy platform creates novel biologic products that are designed to stimulate the human immune system to recognize and attack cancer cells. HyperAcute product candidates are composed of human cancer cells that are tumor specific, but not patient specific. These cells have been modified to express alpha-gal, a carbohydrate for which humans have pre-existing immunity. These alpha-gal-modified cells stimulate a rapid and powerful human immune response that trains the body's natural defenses to seek out and destroy cancer cells. The objective of HyperAcute immunotherapies is to elicit an antitumor response by "educating" the immune system to attack a patient's own cancer cells. HyperAcute immunotherapies do not require any tissue from individual patients and use intact whole cells rather than cell fragments or purified proteins. We believe these unique properties of HyperAcute products result in the stimulation of a robust immune response.

NewLink's lead product candidate, algenpantucel-L (HyperAcute pancreas), is being studied in a Phase 3 trial (IMPRESS: "Immunotherapy for Pancreatic Resectable cancer Survival Study") under a Special Protocol Assessment with the U.S. Food and Drug Administration. This trial involves up to 722 patients with surgically resected pancreatic cancer. Algenpantucel-L is also being tested in a second Phase 3 study (PILLAR: "Pancreatic Immunotherapy with algenpantucel-L for Locally Advanced non-Resectable"), involving patients with locally advanced pancreatic cancer.

NewLink has several HyperAcute product candidates focused on other tumor types in various stages of development, including tergenpumatucel-L, which is in an adaptive design, randomized Phase 2B/3 clinical trial currently accruing up to 240 patients with non-small cell lung cancer.

About IDO pathway inhibition

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NewLink Genetics to Present Data on Cancer Immunotherapy Programs at the ASCO 2013 Annual Meeting

RUTHERFORD, N.J.--(BUSINESS WIRE)--

Cancer Genetics, Inc. (CGIX) ("CGI" or the "Company") is an emerging leader in the diagnosis and disease management for the most complex and difficult-to-treat cancers, including hematologic, urogenital, and gynecological malignancies. CGIs focused portfolio of IP-protected and clinically validated genomic tests, CAP- and CLIA-certified reference laboratory, and suite of unique service offerings are ideally positioned to serve the needs of clinicians, pathologists and laboratories across the entire ecosystem of cancer diagnosis and treatment.CGI today reported financial results for the quarter ended March 31, 2013.

Revenue for the first quarter of 2013 increased 46% to $1.2 million, compared with $835,000 in the first quarter of 2012.

Clinical test volume increased 19% to 1,911 tests in the first quarter, compared with 1,610 tests in the first quarter of 2012.

Average revenue per test increased 23% to $615, from $502 in the first quarter of 2012, driven by an increase in direct bill revenue.

DNA-probe sales by the Companys wholly-owned subsidiary, CGI Italia, increased 193% to $44,000 for the first quarter of 2013, from $15,000 for the same period of 2012.

Gross profit increased to $149,000 in the first quarter, from $12,000 for the same period of 2012, while gross margin improved to 12% compared to 1% in the first quarter of 2012 and 9% for the full year 2012.

Adjusted for a one-time write off of $618,000 in IPO-related costs, operating expenses were unchanged at $1.8 million in the first quarter, compared to the same period of 2012. R&D expense remained relatively flat at $491,000, compared to $524,000 in the first quarter of 2012. Sales and marketing expense increased 16% to $396,000 in the first quarter, from $340,000 in the year-ago period.

Adjusted for the one-time write off in IPO-related costs, loss from operations in the first quarter was $1.7 million, compared to $1.8 million in the same period of 2012.

Net income for the first quarter was $2.4 million, or $1.75 per share, compared to a net loss of $1.1 million, or ($0.81) per share, in the first quarter of 2012. This increase in income was primarily the result of income related to a $5.3 million decrease in the fair value of derivative warrant liability, plus an income tax benefit of $664,000 from the sale of certain net operating losses (NOLs) in the state of New Jersey. These gains were partially offset by the increase in operating loss and an increase in interest expense. Interest expense increased from $865,000 in the first quarter of 2012 to $1.3 million in the first quarter of 2013. As of the Companys initial public offering in April, $9.6 million of debt was converted to equity, which is expected to significantly decrease interest expense going forward.

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Cancer Genetics Announces First Quarter 2013 Financial Results and Significant Business and Portfolio Progress

AMES, IA--(Marketwired - May 16, 2013) - NewLink Genetics Corporation (NASDAQ: NLNK), an oncology-focused biopharmaceutical company specializing in immunotherapy, today announced that it has been selected for addition to the NASDAQ Biotechnology Index (NASDAQ: NBI), effective prior to the market open on Monday, May 20, 2013.

The NASDAQ Biotechnology Index is designed to track the performance of a set of NASDAQ-listed securities classified according to the Industry Classification Benchmark (ICB) as either Biotechnology or Pharmaceuticals. These companies must meet eligibility criteria that include a minimum market capitalization of $200 million and minimum average daily trading volume of 100,000 shares, amongst other requirements.The Index Securities are evaluated semi-annually in May and November and serve as the basis for the iShares NASDAQ Biotechnology Index Fund (NYSE MKT: IBB).For more information about the NASDAQ Biotechnology Index, including eligibility criteria, visit http://www.nasdaq.com.

About NewLink Genetics CorporationNewLink is a biopharmaceutical company focused on discovering, developing and commercializing novel immunotherapeutic products to improve treatment options for patients with cancer.NewLink's portfolio includes biologic and small molecule immunotherapy product candidates intended to treat a wide range of oncology indications.NewLink's product candidates are designed to harness multiple components of the immune system to combat cancer without significant incremental toxicity, either as a monotherapy or in combination with other treatment regimens.For more information please visit http://www.linkp.com.Patient information is available at http://www.pancreaticcancer-clinicaltrials.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of NewLink that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "target," "potential," "will," "could," "should," "seek," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the prospects of our HyperAcute and IDO pathway product candidates and related trials; and any other statements other than statements of historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that NewLink makes due to a number of important factors, including those risks discussed in "Risk Factors" and elsewhere in NewLink's Annual Report on Form 10-K for the period ended December 31, 2012, Quarterly Report on Form 10-Q for the period ended March 31, 2013, Form S-3 Registration Statement filed December 28, 2012 and in its other filings with the Securities and Exchange Commission. The forward-looking statements in this press release represent NewLink's views as of the date of this press release. NewLink anticipates that subsequent events and developments will cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing NewLink's views as of any date subsequent to the date of this press release.

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NewLink Genetics to Be Added to NASDAQ Biotechnology Index

LOS ANGELES, May 16, 2013 (GLOBE NEWSWIRE) -- Response Genetics, Inc. (RGDX), a company focused on the development and sale of molecular diagnostic tests that help determine a patient's response to cancer therapy, today announced that it has entered into an agreement with health insurer Blue Shield of California to join all of Blue Shield of California's provider networks.

The agreement marks Response Genetics' first Blue Cross Blue Shield-affiliated contract and will offer Blue Shield of California's membership access to Response Genetics' portfolio of predictive genetic testing. Blue Shield of California, an independent member of the Blue Cross Blue Shield Association, is a not-for-profit health plan with approximately 3.0 million members and 5,000 employees. Response Genetics' specialization focuses on the linkage between the genetic profile of an individual cancer patient's tumor and various drugs that may be used to fight that cancer. This partnership between Blue Shield of California and Response Genetics will enhance Blue Shield of California members' access to personalized medicine.

About Response Genetics, Inc.

Response Genetics, Inc. (the "Company") is a CLIA-certified clinical laboratory focused on the development and sale of molecular diagnostic testing services for cancer. The Company's technologies enable extraction and analysis of genetic information derived from tumor cells stored as formalin-fixed and paraffin-embedded specimens. The Company's principal customers include oncologists and pathologists. In addition to diagnostic testing services, the Company generates revenue from the sale of its proprietary analytical pharmacogenomic testing services of clinical trial specimens to the pharmaceutical industry. The Company's headquarters is located in Los Angeles, California. For more information, please visit http://www.responsegenetics.com.

About Blue Shield of California

Founded in 1939 and headquartered in San Francisco, Blue Shield of California is the third largest health insurance carrier in the state. The company provides health, life, dental, vision, and Medicare insurance and health care service plans in California, has one of the largest provider networks, and $9.7 billion in annual revenue. In 2012, Blue Shield of California was named one of the World's Most Ethical Companies.

Forward-Looking Statement Notice

Except for the historical information contained herein, this press release and the statements of representatives of the Company related thereto contain or may contain, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions, such as the ability of the Company, to provide clinical testing services to the medical community, to continue to strengthen and expand its sales force, to continue to build its digital pathology initiative, to attract and retain qualified management, to continue to strengthen marketing capabilities, to expand the suite of ResponseDX(R) products, to continue to provide clinical trial support to pharmaceutical clients, to enter into new collaborations with pharmaceutical clients, to enter into areas of companion diagnostics, to continue to execute on its business strategy and operations, to continue to analyze cancer samples and the potential for using the results of this research to develop diagnostic tests for cancer, the usefulness of genetic information to tailor treatment to patients, and other statements identified by words such as "project," "may," "could," "would," "should," "believe," "expect," "anticipate," "estimate," "intend," "plan" or similar expressions.

These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities Exchange Commission. Actual results, including, without limitation, actual sales results, if any, or the application of funds, may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by law.

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Response Genetics, Inc. Announces Contract With Blue Shield of California

Susie discusses her combination cell therapy from Dr Harry Adelson for her spine pain
Susie discusses her combined cell treatment from Dr Harry Adelson for her spine pain. Dr Adelson practices in Park City, Utah and has been performing proloth...

By: Harry Adelson

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Susie discusses her combination cell therapy from Dr Harry Adelson for her spine pain - Video

The actress's candid op-ed about her mastectomy comes on the eve of a vital ruling over patents for breast cancer genes like hers.

Alastair Grant/Reuters

When Angelina Jolie disclosed Tuesday morning that she had undergone a preventive double mastectomy, she didn't just shine her white-hot starlight on the gene, BRCA1, that significantly increased her chance of getting breast cancer. She also indirectly raised anew profound questions the federal judiciary -- and now the United States Supreme Court -- has been pondering for years: Where does patent law stand on gene research? Where should it stand? Can the law protect patent holders while also ensuring that the marketplace can most efficiently deliver genetic testing to the people who need it most?

The timing of Jolie's op-ed inthe New York Times is important. Within the next 45 days, before the last Thursday in June, the Supreme Court is expected to issue its ruling in Association for Molecular Pathology v. Myriad Genetics, Inc., a long-fought case about genes, including BRCA1 and BRCA2, which are linked to breast cancer and which Myriad Genetics successfully patented (The company's stock rose sharply Tuesday following the publication of Jolie's piece.) The federal case began four years ago, in May 2009, when the American Civil Liberties Union and others challenged Myriad's patents on the genes. From that initial complaint:

Ease of access to genomic discoveries is crucial if basic research is to be expeditiously translated into clinical tests that benefit patients in the emerging era of personalized and predictive medicine. The patents make ease of access more restricted. Because of the patents, defendant Myriad has the right to prevent clinicians from independently looking at or interpreting a person's BRCA1 and BRCA2 genes to determine if the person is at a higher risk of breast and/or ovarian cancer. Because of the patents and because Myriad chooses not to license the patents broadly, woman who fear they may be at an increased risk of breast and/or ovarian cancer are barred from having anyone look at their BRCA1 and BRCA 2 genes or interpret them except for the patent holder.

The gene-patenting case has gone back and forth. In November 2009, a federal trial judge in New York refused to dismiss the complaint. Then, in March 2010, in a 156-page opinion, the judge invalidated two of those patents, concluding that the "DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes." Myriad appealed. In August 2011, a panel of the Federal Circuit, which handles all patent cases, by a vote of 2-1, overturned the lower court ruling. On April 15, just one month ago, the justices in Washington heard oral argument in the case. Here's the transcript. And here's the Court's audio.

It is more likely than not that the justices will uphold Myriad's patent -- its monopoly -- over research for these genes. This is that type of Court. But no matter what the justices do in this case Congress has the authority to amend federal patent law to make it harder for companies like Myriad to control for so long the research and development of such genetic testing. In the meantime, the Affordable Care Act also will play a critical role in making it easier for women who are not Angelina Jolie to have more access to timely BRCA testing. "BRC Testing Granted Preventive Care Designation Under the Affordable Care Act," screamed Myriad's press release on March 6th. How do you like Obamacare now?

Jolie or no Jolie, the Myriad litigation is a perfect example of how poorly the law is suited to adapt quickly to biological or technical advancements. In the area of gene-patenting, like so many other areas we care far less about, the medical science is developing far more quickly than the courts can fathom. Patents are supposed to be tools to encourage the creation of things that better society as a whole. And Myriad says that these particular gene patents are economically necessary to fuel research and development. But how many more women -- and men -- might have been able over the past four years to afford BRCA1 or BRCA2 testing in the absence of those protective patents?

It's not necessarily Myriad's fault. The company is playing by the rules Congress and the courts have established. But to the extent they preclude open competition, in the ways in which they create sanctioned monopolies, these patents are the antithesis of capitalism. The societal costs may be worth it when the patent is for a new kind of chewing gum. But when the patent is for an isolated human gene, and when that gene may hold the key to diagnosing breast cancer, is the protection of the patent good public policy? I'm just asking the question. I'm not answering it.

Excerpt from:
The Court Case Looming Behind Angelina Jolie's Breast Cancer Column

LA JOLLA, Calif. and ROCKVILLE, Md., May 15, 2013 /PRNewswire/ --A team of international researchers from the J. Craig Venter Institute (JCVI), Synthetic Genomics Inc. (SGI), Novartis Vaccines and Diagnostics, the Biomedical Advanced Research and Development Authority (BARDA, US Department of Health and Human Services), and Institut fur Virologie, Phillips Universitat, has published a study detailing new methods to rapidly generate influenza vaccine seeds by using synthetic genomics tools and technologies.

The team led by first author Philip R. Dormitzer, M.D., Ph.D., and senior authors J. Craig Venter, Ph.D., JCVI and SGI, and Rino Rappuoli, Ph.D., Novartis, published their study in the May 15 edition of the journal Science Translational Medicine. In a timed proof of concept this team demonstrated that in just four days and four hours they could accurately construct robust synthetic vaccine viruses for use in influenza vaccine development. The team concludes that this is a novel and accurate method that could enable a more rapid pandemic response and yield a more reliable supply of better matched seasonal and pandemic vaccines than are currently available.

"Our teams have been working hard to put our combined expertise to work toward the development of next generation vaccines," said Dr. Venter, CEO and Founder of JCVI and SGI. "We believe that synthetic genomic advances hold the key to transforming many industries and one of the most important will be in advanced vaccines that have the power to help prevent public health threats such as influenza pandemics."

The study details the synthetic vaccine techniques and methods developed by the team after the 2009 H1N1 influenza pandemic. While the response to this pandemic was the fastest in history, vaccines only became available after the rate of human infections had peaked. Novartis and other vaccine companies have relied on the World Health Organization (WHO) to identify and distribute live reference viruses or viral genes to create seasonal or pandemic vaccines. The 2010 publication of the first synthetic cell constructed by the team at JCVI described new synthetic genomic tools and techniques that were adapted to create flu vaccine viruses.

Since October 2010 Novartis, JCVI and SGI/Synthetic Genomics Vaccines Inc. (SGVI) have been working together through a BARDA-sponsored program to apply synthetic genomics tools and technologies to accelerate the production of the influenza vaccine virus strains required for vaccine manufacturing. The vaccine virus strain is the starter preparation of a virus and is the base from which larger quantities of the vaccine virus can be grown. The goal of this collaboration is to develop a "bank" of synthetically constructed vaccine viruses ready to go into production as soon as WHO identifies the flu strains. This paper outlines results of some of the first successful outcomes of this collaboration.

The researchers focused on three technological areas--speedy synthesis of DNA cassettes to produce influenza RNA genome segments, improved accuracy of rapid gene synthesis by improving error correction technology, and increased yields of hemagglutinin (HA), which is the essential vaccine antigen.

In the traditional approach to vaccine development, an influenza virus is cultured and grown in chicken eggs. The synthetic genomics approach starts with virus genome sequence data in the computer.

The team then employed synthetic genomics tools to synthesize the two antigens used in vaccine production, HA and neuraminidase (NA). To do this they developed a new cell-free gene assembly method coupled with the improved one step enzymatic error correction method for rapid and accurate gene synthesis. Although gene synthesis is now commonplace, it is still difficult to rapidly and accurately construct large pieces of DNA, large genes and whole genomes. Daniel Gibson, PH.D., and his team at SGI-DNA, along with teams at JCVI, are world leaders in the design and construction of such large gene constructs. It took the team only approximately 10 hours to construct and assemble the synthetic HA- and NA-encoding DNA cassettes ready for transfection into Madin-Darby canine kidney (MDCK) cells. This method enables the rapid and accurate conversion of digital sequence information to biologically active DNA. This is one of the key differences in synthetically derived vaccines versus traditionally developed vaccines.

The next step developed and described by the team involves rescuing the vaccine virus from the manufacturing cell line. The team employed a novel method of using one cell line for both seed generation and vaccine antigen production. This adds to the efficiency of the new vaccine production and alleviates some of the regulatory and manufacturing complexity.

"As an industry leader in the research, development, manufacture and supply of flu vaccines, Novartis is committed to identifying new ways to speed development of safe and efficacious vaccines to protect patients from seasonal flu and potential pandemics," said Rino Rappuoli, Head, Vaccines Research, Novartis Vaccines and Diagnostics. "Our research shows the potential power of synthetic vaccine development in addressing emerging public health threats. By electronically transmitting genetic information rather shipping biological materials, we can begin development of new vaccines more quickly, and ultimately, better protect global health."

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Research Team Publishes New Methods for Synthetic Generation of Influenza Vaccines

The actress's candid op-ed about her mastectomy comes on the eve of a vital ruling over patents for breast cancer genes like hers.

Alastair Grant/Reuters

When Angelina Jolie disclosed Tuesday morning that she had undergone a preventive double mastectomy, she didn't just shine her white-hot starlight on the gene, BRCA1, that significantly increased her chance of getting breast cancer. She also indirectly raised anew profound questions the federal judiciary -- and now the United States Supreme Court -- has been pondering for years: Where does patent law stand on gene research? Where should it stand? Can the law protect patent holders while also ensuring that the marketplace can most efficiently deliver genetic testing to the people who need it most?

The timing of Jolie's op-ed inthe New York Times is important. Within the next 45 days, before the last Thursday in June, the Supreme Court is expected to issue its ruling in Association for Molecular Pathology v. Myriad Genetics, Inc., a long-fought case about genes, including BRCA1 and BRCA2, which are linked to breast cancer and which Myriad Genetics successfully patented (The company's stock rose sharply Tuesday following the publication of Jolie's piece.) The federal case began four years ago, in May 2009, when the American Civil Liberties Union and others challenged Myriad's patents on the genes. From that initial complaint:

Ease of access to genomic discoveries is crucial if basic research is to be expeditiously translated into clinical tests that benefit patients in the emerging era of personalized and predictive medicine. The patents make ease of access more restricted. Because of the patents, defendant Myriad has the right to prevent clinicians from independently looking at or interpreting a person's BRCA1 and BRCA2 genes to determine if the person is at a higher risk of breast and/or ovarian cancer. Because of the patents and because Myriad chooses not to license the patents broadly, woman who fear they may be at an increased risk of breast and/or ovarian cancer are barred from having anyone look at their BRCA1 and BRCA 2 genes or interpret them except for the patent holder.

The gene-patenting case has gone back and forth. In November 2009, a federal trial judge in New York refused to dismiss the complaint. Then, in March 2010, in a 156-page opinion, the judge invalidated two of those patents, concluding that the "DNA's existence in an 'isolated' form alters neither this fundamental quality of DNA as it exists in the body nor the information it encodes." Myriad appealed. In August 2011, a panel of the Federal Circuit, which handles all patent cases, by a vote of 2-1, overturned the lower court ruling. On April 15, just one month ago, the justices in Washington heard oral argument in the case. Here's the transcript. And here's the Court's audio.

It is more likely than not that the justices will uphold Myriad's patent -- its monopoly -- over research for these genes. This is that type of Court. But no matter what the justices do in this case Congress has the authority to amend federal patent law to make it harder for companies like Myriad to control for so long the research and development of such genetic testing. In the meantime, the Affordable Care Act also will play a critical role in making it easier for women who are not Angelina Jolie to have more access to timely BRCA testing. "BRC Testing Granted Preventive Care Designation Under the Affordable Care Act," screamed Myriad's press release on March 6th. How do you like Obamacare now?

Jolie or no Jolie, the Myriad litigation is a perfect example of how poorly the law is suited to adapt quickly to biological or technical advancements. In the area of gene-patenting, like so many other areas we care far less about, the medical science is developing far more quickly than the courts can fathom. Patents are supposed to be tools to encourage the creation of things that better society as a whole. And Myriad says that these particular gene patents are economically necessary to fuel research and development. But how many more women -- and men -- might have been able over the past four years to afford BRCA1 or BRCA2 testing in the absence of those protective patents?

It's not necessarily Myriad's fault. The company is playing by the rules Congress and the courts have established. But to the extent they preclude open competition, in the ways in which they create sanctioned monopolies, these patents are the antithesis of capitalism. The societal costs may be worth it when the patent is for a new kind of chewing gum. But when the patent is for an isolated human gene, and when that gene may hold the key to diagnosing breast cancer, is the protection of the patent good public policy? I'm just asking the question. I'm not answering it.

Read the original post:
The Supreme Court Case Looming Over Angelina Jolie's Breast-Cancer Column

WEDNESDAY, May 15 (HealthDay News) -- Weight gain in men and women is predicted by two different genetic variations -- so-called polymorphisms, according to a new study from the Netherlands.

Men with a certain mutation of the FTO gene had an 87 percent greater risk for gaining weight over 10 years. Meanwhile, women with a different variation on the MMP2 gene had a two and a half times increased risk for weight gain over the course of a decade, the researchers found.

The research involved two groups of people: The first group, which consisted of 259 people, maintained a stable weight; the second group consisted of 237 people who were considered weight gainers. These participants gained about 17 pounds over 10 years.

Starting body-mass index -- a measurement of body fat based on a person's ratio of height to weight -- for the participants ranged from normal to obese. Participants were between 20 and 45 years old when the study began.

The research, led by Freek Bouwman, from Maastricht University, and Dr. Jolanda Boer, from the Netherlands' National Institute for Public Health and the Environment, focused on several different polymorphisms associated with weight gain in previous studies.

The genetic distribution of a particular FTO polymorphism in men was consistently different between the weight-stable group and the weigh-gainer group, the study revealed, according to a news release from the European Congress on Obesity.

Similarly, among the women, the genetic distribution of the MMP2 polymorphism varied between those considered weight stable and those in the weight-gainer group.

"We found that FTO in men and MMP2 in women are predictors for weight gain over a 10-year follow-up period," the study authors wrote.

They suggested that more research into these polymorphisms could help determine who is at greatest risk for weight gain and improve weight-control strategies. They said differences in male and female hormone levels also could play a role in weight regulation.

The study was presented Tuesday at the European Congress on Obesity in Liverpool, England. Findings presented at medical meetings should be viewed as preliminary until published in a peer-reviewed journal.

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Gene variations may explain weight gain among men, women

STORY HIGHLIGHTS

Editor's note: Dr. Susan Domchek is a board-certified medical oncologist at the University of Pennsylvania's Abramson Cancer Center. She is director of the Mariann and Robert MacDonald Women's Cancer Risk Evaluation Center and executive director of the Basser Research Center for BRCA, a newly founded center focused exclusively on issues related to BRCA1 and BRCA2 gene mutations.

(CNN) -- News of Angelina Jolie's decision to undergo a prophylactic double mastectomy has instantly increased awareness of hereditary forms of cancer caused by mutations in the BRCA1 and BRCA2 genes.

While the BRCA1 and BRCA2 genes were discovered in the mid-1990s, genetic testing for the genes is increasingly available. Jolie's case highlights the importance of knowing one's family history and learning one's cancer risks in order to address them proactively.

Everyone has the BRCA1 and BRCA2 genes. We have two copies of each gene and get one each from our mother and father. They play a role in protecting the body against the development of cancer.

Individuals with mutations in either of these genes have increased cancer risks, most notably for breast and ovarian cancer. Individuals with mutations in BRCA1 and BRCA2 benefit from tailored management aimed at reducing cancer risks and detecting cancers early when they are most treatable.

Genetic counselors and other health care providers can help determine if testing is appropriate and who in the family should undergo testing first. In addition, it is important to provide educational and anticipatory guidance on the impact and implications of genetic test results.

Opinion: When removing breast is not the answer

Here are some common questions that our team is asked regarding genetic testing for breast and ovarian cancer:

What is BRCA testing?

Originally posted here:
The cancer gene: 7 questions

Public release date: 14-May-2013 [ | E-mail | Share ]

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, May 14, 2013Animals, insects, and plants use a variety of sensing mechanisms to detect invading pathogens such as viruses. One complex and effective antiviral defense system they share is based on recognition of double-stranded RNA (dsRNA), often produced when a virus invades a host cell. New information leading to a clearer understanding of the mechanisms underlying viral dsRNA sensing is presented in a comprehensive Review article published in Journal of Interferon & Cytokine Research, a peer-reviewed publication from Mary Ann Liebert, Inc., publishers. The article is available free online on the Journal of Interferon & Cytokine Research website.

Isaque Joo da Silva de Faria and coauthors from Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, describe two families of sensors that share a region with high specificity for viral dsRNA. In the article "dsRNA Sensing During Viral Infection: Lessons from Plants, Worms, Insects and Mammals" they explain that while this shared region is necessary for dsRNA recognition, it is not sufficient. The authors review recent studies that have identified novel components of these antiviral recognition systems that contribute to their complexity and effectiveness in protecting hosts against viral infection.

"While dsRNA has long been recognized as a product of viral infection, the understanding of cellular mechanisms for its recognition and for subsequent response has increased dramatically in recent years. This review addresses the impact of this new information," says Co-Editor-in-Chief Thomas A. Hamilton, PhD, Chairman, Department of Immunology, Cleveland Clinic Foundation.

###

About the Journal

Journal of Interferon & Cytokine Research, led by Co-Editors-in-Chief Ganes C. Sen, PhD, Chairman, Department of Molecular Genetics, Cleveland Clinic Foundation, and Thomas A. Hamilton, PhD, is an authoritative peer-reviewed journal published monthly online with Open Access options and in print that covers all aspects of interferons and cytokines from basic science to clinical applications. Journal of Interferon & Cytokine Research is the official journal of the International Society for Interferon and Cytokine Research. Complete tables of content and a sample issue (http://online.liebertpub.com/toc/jir/32/6) may be viewed online on theJournal of Interferon & Cytokine Research website.

About the Publisher

Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Viral Immunology, AIDS Research and Human Retroviruses, and DNA and Cell Biology. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's over 70 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.

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What is the role of double-stranded RNA in antiviral host defense systems?

Public release date: 14-May-2013 [ | E-mail | Share ]

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, May 14, 2013Breastfeeding has a positive impact on the physical and mental development of infants. A new study suggests that breastfeeding may protect against the development of attention-deficit/hyperactivity disorder (ADHD) later in childhood. The study is reported in Breastfeeding Medicine, the Official Journal of the Academy of Breastfeeding Medicine, published by Mary Ann Liebert, Inc., publishers. The article is available free on the Breastfeeding Medicine website at http://www.liebertpub.com/bfm.

A team of Israeli researchers led by Aviva Mimouni-Bloch, MD compared breastfeeding history and other factors in a group of children 6-12 year of age diagnosed with ADHD to control groups of children who did not have ADHD. The results demonstrated that overall, the children with ADHD were less likely to have been breastfed at 3 and 6 months of age than the children without ADHD. This association between ADHD and lack of breastfeeding was statistically significant.

"Breastfeeding has been shown to have a positive impact on child development, good health, and protection against illness. Now, another possible benefit of breastfeeding for three months and especially six months or longer has been identified," says Ruth Lawrence, MD, Editor-in-Chief of Breastfeeding Medicine and Professor of Pediatrics, University of Rochester School of Medicine. "This study opens another avenue of investigation in the prevention of ADHD."

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About the Journal

Breastfeeding Medicine, the Official Journal of the Academy of Breastfeeding Medicine, is an authoritative, peer-reviewed journal published bimonthly in print and online. The Journal publishes original scientific papers, reviews, and case studies on a broad spectrum of topics in lactation medicine. It presents evidence-based research advances and explores the immediate and long-term outcomes of breastfeeding, including the epidemiologic, physiologic, and psychological benefits of breastfeeding. Tables of content and a sample issue may be viewed on the Breastfeeding Medicine website at http://www.liebertpub.com/bfm.

About the Publisher

Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Journal of Women's Health, Childhood Obesity, and Pediatric Allergy, Immunology, and Pulmonology. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN) was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 70 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website at http://www.liebertpub.com.

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Can breastfeeding protect against ADHD?

Even celebrities are mortal. They share our genes and, like us, cannot escape their inheritance. Angelina Jolies graceful and dignified account of her encounter with her own mortality in The New York Times will inspire millions.

It will also shine a light on the developing science of genetic diagnosis and DNA profiling which is increasingly allowing patients at high risk of inherited diseases to be identified so that they can take preventive action.

The BRCA1 and BRCA2 genes were the first to be identified in breast and ovarian cancer more than 20 years ago. The presence of faulty versions of the genes increases the risk of the diseases by at least 50 per cent, the exact proportion depending on other factors. Just as the risk varies from woman to woman, so does the response.

In Ms Jolies case it was radical surgery to remove her breasts. About 3,000 women in the UK have done likewise. But for other women the decisions required may be less radical and distressing, involving modifying lifestyle, having regular mammograms or MRI scans or starting a course of preventive drugs.

Only last January, the UKs National Institute for Clinical Excellence recommended for the first time in draft guidance that women at high risk of breast cancer be prescribed the drug tamoxifen or a related drug as a preventive measure. Tamoxifen has been established as a treatment for the disease for decades.

Ms Jolie, however, opted for surgery with its more certain outcome. Doctors told her that her risk was raised by 87 per cent and reduced to 5 per cent by the removal of her breasts. Take away most of the tissue where the cancer develops and you take away most of the risk.

She chose nipple preserving surgery one of the toughest choices women in her position have to make. It meant that some breast tissue was left behind. But after reconstruction with implants, her breasts would look normal following the operation which was important to reassure her children.

They can see my small scars and thats it. Everything else is just Mommy, the same as she always was, she wrote.

The maximum protection from the surgery is achieved by removing the maximum amount of tissue. But removal of the nipple is a disfiguring operation and a step too far for many women.

Genetic testing of the kind Ms Jolie underwent is becoming increasingly common. Testing for the presence of specific mutations is already available for a range of cancers, including those of the womb, bowel, stomach and bladder, where the presence of an inherited faulty gene may increase the risk by between 10 and 60 per cent

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Angelina Jolie's screen test puts genetic key to breast cancer in the spotlight

Advanced genetic engineering is already changing vaccine development and could make inroads into other branches of medicine.

Synthetic biology is breathing new life into the old-fashioned world of vaccine production, raising hopes that manufacturers could release vaccines much more quickly when outbreaks occur.

At a meeting on synthetic biology held at MIT, the drug company Novartis said it has synthesized hybrid flu genomes in a process that could shave weeks off the time required to produce vaccines. When new flu strain emerges, government agencies normally send samples to vaccine manufacturers, who grow large numbers of the pathogen in chicken eggs as starting material for vaccines, says Philip Dormitzer, leader of viral vaccine research for Novartis. This process can take months and can miss the peak of an outbreak. But Novartis, working with synthetic biologists, has developed a way of chemically synthesizing virus genomes and growing them in tissue culture cells. That saves time and may produce more effective vaccines.

The idea is to build a synthetic virus based on sequence data that can be distributed much more quickly than actual viral material harvested at the site of an outbreak. The synthetic viral genome combines a genomic backbone common to many flu viruses with genes specific to the strains seen in a new outbreak. In 2011, the team tested its method in response to a mock outbreak of a bird-flu virus (one closely related to the H7N9 virus currently spreading in China). Starting at 8 a.m. on Monday that year, the team began to chemically synthesize a viral genome based on sequence data, says Dormitzer. By noon the following Friday, the team had confirmed that it had live virus growing in cell culture.

Until recently, most synthetic-biology efforts have focused on engineering bacteria to produce desirable compounds such as drugs (see Microbes Can Mass-Produce Malaria Drug) or fuel (see Bacteria Make Diesel from Biomass); they havent involved humans or other mammals. But that is changing. Mammalian synthetic biology, which involves modifying mammalian genetic circuits, is still in relative infancy, says Jim Collins, a synthetic biologist at Boston University. There are only a handful of groups in the space, and its very hard to do that engineering, he says.

In other work described at the Cambridge meeting, Pam Silver, a synthetic biologist at Harvard Medical School, presented methods for cell-based computing, in which logic gates can be built from engineered proteins. One application of these tools is a genetic circuit that enables cells to remember if they were exposed to radiation, even after the radiation is gone. So far, she and her team have built such a circuit in yeast cells, but she says the technology could transfer to human cells. That could be a useful situation in therapy and long term for space travel, and also for simply reporting on the experiences of cells in the body, says Silver.

Some efforts to apply synthetic biology to health focus on programming stem cells to behave like naturally occurring cells that have been lost because of disease. Douglas Melton, a molecular and cell biologist at Harvard University, is programming stem cells to replace the glucose-sensing and insulin-producing cells lost in type 1 diabetes. This condition usually arises from an autoimmune reaction against the beta cells of the pancreas, which leaves the body without insulin.

Melton and his lab are working toward a technology in which the beta cells and other cells involved in regulating blood sugar could be replaced by encapsulated collections of mature cells derived from stem cells. The challenge will be to produce the final, differentiated cell types using hormones or other chemical signals to guide the development process. What one wants to understand is how to instruct the cell as to which genes it should turn on and off, says Melton.

But replicating the natural processes of cellular development isnt easy. Melton says his group is able to make beta cells that produce insulin, but the process is imperfect. About half of the cells do what you want to do, he says. We dont know how to tell the cells to be only beta cells. And the cultured beta cells do not have the finely tuned response to glucose that the bodys cells do: Beta cells have to sense glucose levels and then squirt out the right amount of insulin, he says. Our cells will respond to glucose, but not with accurate sensing mechanisms. They usually dump insulin on the first [sign] of glucose.

Other researchers are hoping to engineer entirely new circuits into cells to help diabetes patients. Martin Fussenegger, a bioengineer at the Swiss Federal Institute of Technology, described a molecular system in which cells are modified with genes that can detect low pH levels in the blood, a sign of a diabetic state. In response, he says, the engineered cells will produce insulin to better regulate blood sugar levels and calm the diabetic state.

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Synthetic Biology Could Speed Flu Vaccine Production

NEW YORK, May 15, 2013 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Genetic Testing Market Outlook to 2017

http://www.reportlinker.com/p01182998/Genetic-Testing-Market-Outlook-to-2017.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Genomics

A recent report, "Genetic Testing Market Outlook to 2017", provides an in-depth analysis of the current and future genetic testing market. A comprehensive introduction of gene-based tests, their working principles and types are covered in around a 140-page report. On account of our analysis of the past and present market trends; drivers; and existing strengths and challenges; forecast for genetic testing has been drawn, according to which, the market is likely to grow at a CAGR of around 9% during 2012-2017.

Our report is an outcome of extensive interaction with industry experts which has led us to portray the updated status of genetic testing in various therapeutic areas, major geographies and significant industry applications. The genetic testing industry has seen several new product launches, active research innovations, strategic activities, launch of new DTC tests, and wider therapeutic applications.

The report effectively illustrates the role of genetic testing in diseases such as Cancer, Cystic Fibrosis, and Alzheimer. It also incorporates the information on disease prevalence, available tests, and genes that cause a particular disease. An extensive research and reliable statistics in terms of market size, developments and future performance for emerging sectors namely, Next-Generation Sequencing, Whole Genome Sequencing, Non Invasive Prenatal Diagnostics, and Personalized Medicine have been covered in the report.

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Genetic Testing Market Outlook to 2017

New personalized medicine initiative enables doctors to tailor drug therapies to individual patients based on genetic profile

Newswise BALTIMORE May 14, 2013. Patients with coronary artery disease who undergo treatment at the University of Maryland Medical Center now can receive long-term therapy based on information found in their genes. As part of a new personalized medicine initiative, the medical center is offering genetic testing to help doctors determine which medication a patient should take after a stenting procedure in order to prevent blood clots that could lead to serious and potentially fatal heart attacks and strokes.

Patients with suspected heart disease undergo coronary catheterization to identify blocked or narrow arteries. Tiny tubes, or stents, are often placed in the arteries to keep them open, and, after surgery, patients typically take antiplatelet drugs, such as clopidogrel (Plavix), to prevent platelets blood cells produced in bone marrow from sticking together and forming clots.

Now, patients who undergo coronary catheterization at UMMC and the Baltimore VA Medical Center, both of which are affiliated with the University of Maryland School of Medicine, can elect to be tested for variations in a gene called CYP2C19. Up to one-fourth of the U.S. population carries at least one abnormal copy of the CYP2C19 gene, and research has shown that as a result, these individuals do not metabolize the standard anti-clotting medication clopidogrel effectively.

There is strong clinical data to support pharmacogenetic testing in regard to antiplatelet therapy, says Alan R. Shuldiner, M.D., the John L. Whitehurst Endowed Professor of Medicine, associate dean for personalized medicine and director of the Program in Personalized and Genomic Medicine at the University of Maryland School of Medicine. Its time to incorporate genetics into the complex medical decisions that we make on behalf of our patients.

In 2009, Dr. Shuldiner led a University of Maryland study, published in JAMA, which showed that patients with a CYP2C19 gene variation exhibited reduced clinical benefit from taking clopidogrel. Based on growing clinical evidence reported in Dr. Shuldiners study and others, the U.S. Food and Drug Administration issued a warning about the reduced efficacy of clopidogrel in people with the genetic variation.

Pharmacogenetic testing enables us to tailor drug treatments to individual patients based on their unique genetic makeup, or genotype, says Dr. Shuldiner, an endocrinologist and geneticist. With genotype-directed therapy, we have the ability to change the one size fits all approach to prescribing medication and ultimately improve the quality of care we provide to our patients. Patients want personalized and individualized medicine. They seek it out.

The test is performed by analyzing the patients DNA, isolated from a blood sample, in a new state-of-the-art translational genomics laboratory at the University of Maryland School of Medicine. The tests are being conducted as part of a National Institutes of Health (NIH)-funded study to determine the best way to implement genetic-testing programs. Tests are free, and because of the partnership between UMMC and the University of Maryland School of Medicine, results are available within a few hours.

Dr. Shuldiner explains that the ability to provide test results within hours is crucial because cardiac stent patients are at risk for developing blood clots and other complications soon after they have the procedure. This rapid turnaround time sets our program apart from other programs and commercial laboratories, where results may not be available for up to two weeks, he adds.

Pharmacogenomics how genes affect a persons response to drugs is a burgeoning area of research, but only a small number of hospitals in the United States have programs to offer routine genetic testing as part of their clinical practice. This new approach to patient care is part of the University of Maryland School of Medicines pursuit of more individualized, or personalized, medical treatment.

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University of Maryland Medical Center Launches Genetic-Testing Program for Cardiac Stent Patients

GeneticS Gaming l Introducing TeNziKa- / GeneticS-TenZ
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GeneticS Gaming l Introducing TeNziKa- / GeneticS-TenZ - Video

Mallowbops- genetics made easy
These little creatures will unravel the world of genetics! Or they may just run around 😉

By: Glen Dawkins

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Mallowbops- genetics made easy - Video

GeneticS Gaming l Introducing X_KillerxFrann_X
Game Clip.

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GeneticS Gaming l Introducing X_KillerxFrann_X - Video

Cancer test developer Myriad Genetics (MYGN) saw its shares climb 4% Tuesday, a move that followed word from actress Angelina Jolie that she had a double mastectomy after learning she was at high risk for breast cancer.

Jolie wrote in a New York Times column published late Monday that she underwent voluntary surgery to remove her breasts because a genetic mutation she carries means she has an up to 87% chance of developing the disease in her lifetime. The 37-year-old actress, known for movies such as "Gia" and "Lara Croft: Tomb Raider," led her announcement by noting that her mother died of breast cancer at age 56.

Salt Lake City-based Myriad has a test called the BRACAnalysis that's designed to determine a woman's risk of getting hereditary breast or ovarian cancer by looking for defects in the BRCA1 or BRCA2 genes. These mutations, the company says, are the cause of most hereditary breast cancer cases. Jolie wrote in her guest piece that she has the BRCA1 mutation.

In recent trading, Myriad, which researches tests for several cancers, including colorectal cancer and pancreatic cancer, was up $1.34 to $34.45. The stock is at its best level since mid-2009, according to Yahoo Finance data.

"Once I knew that this was my reality, I decided to be proactive and to minimize the risk as much I could," Jolie said in the column. "I made a decision to have a preventive double mastectomy. I started with the breasts, as my risk of breast cancer is higher than my risk of ovarian cancer, and the surgery is more complex."

She said she hoped other women would have the genetic test, and, should they learn they have a greater risk of getting breast or ovarian cancer, "know that they have strong options."

The National Cancer Institute expects more than 232,000 women in the U.S. to be diagnosed with some type of breast cancer this year. It predicts breast cancer will cause 39,620 female deaths. While unusual, men can also get breast cancer. About 2,200 new cases are foreseen in America in 2013, with 410 deaths. Myriad says around 7% of breast cancers are a result of the BRCA1 or BRCA2 defects.

Myriad was in the news earlier this spring by being involved in a legal case on whether patenting human genes should be allowed. A ruling by the Supreme Court will come later this year.

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Myriad Genetics Shares Climb After Angelina Jolie Has Mastectomy

SALT LAKE CITY, May 14, 2013 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN) announced today that Peter D. Meldrum, president and CEO, is scheduled to present at the Bank Of America Merrill Lynch 2013 Health Care Conference, at 10:00 a.m. Pacific on May 16, 2013, at the Encore at the Wynn in Las Vegas, Nevada.

The presentation will be available to interested parties through a live audio webcast accessible through a link on the investor relations section of Myriad's Web site at http://www.myriad.com.

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: http://www.myriad.com.

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Myriad Genetics to Present at the Bank of America Merrill Lynch Health Care Conference

NEW YORK (AP) -- Shares of diagnostic test maker Myriad Genetics Inc. rose to a three-year high Tuesday, as analysts said actions by the Supreme Court and actress Angelina Jolie could both help the company.

THE SPARK: Oscar-winner Jolie disclosed Tuesday that she recently had a preventative double mastectomy after learning she faced a high risk of breast and ovarian cancer because of an inherited genetic mutation. Myriad makes a test called BRACAnalysis that looks for that mutation, and the test is the source of most of the company's revenue.

On Monday the U.S. Supreme Court upheld Monsanto Co.'s claim that a farmer in Indiana violated one of its patents on soybean seeds. The patents covered genetic modification that made the seeds resistant to Monsanto's Roundup herbicide. The high court recently heard a legal challenge to some of Myriad's genetic patents, and analysts said Monday's ruling could be good news for Myriad.

THE BIG PICTURE: BRACAnalysis looks for mutations on the breast cancer predisposition gene, or BRCA. Women with mutations on that gene have a three-to-seven times greater risk of developing breast cancer and also a higher risk of ovarian cancer. In the first quarter of 2013 almost three-quarters of Myriad's revenue came from BRACAnalysis testing.

In the U.S. 5 to 10 percent of breast cancer cases are thought to be linked to BRCA genes. Women of Eastern European Jewish descent are more likely to have faulty copies of the BRCA gene. Women who have inherited the gene are about five times more likely to get breast cancer.

In mid-April the Supreme Court heard a case related to the patenting of human genes. The case challenges two patents Myriad holds on genes related to the BRACAnalysis test. The American Civil Liberties Union and other groups have argued that the government shouldn't award patents on genes.

The Patent & Trademark office has been awarding such patents for decades. A High Court ruling is expected by June.

Analysts expect Myriad's patents to be upheld and note that even if the Supreme Court invalidates the patents, the company has other patents supporting the test.

THE ANALYSIS: In an email Cowen & Co. analyst Doug Schenkel said there is comparatively little testing of women who, like Jolie, don't have cancer or cancer symptoms but have an increased risk of the disease because of their family history or ethnic background. He said Jolie's story increases awareness of the BRACAnalysis test and of the risk some women face, and that's good news for the company.

William Blair analyst Amanda Murphy said in an email that she believes the Monsanto decision was a bigger factor in Tuesday's stock movement. She said the court recognized the investment that companies like Monsanto have to make in research and development, and that issue was also discussed during oral arguments in the Myriad case.

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Myriad Genetics shares rise to three-year highs

RUTHERFORD, N.J.--(BUSINESS WIRE)--

Cancer Genetics, Inc. (CGIX) ("CGI" or the "Company"), a leader in oncology-focused personalized medicine, will sponsor and host a roundtable discussion at the second annual BioNJ Diagnostics & Personalized Medicine Innovation Summit on Thursday, June 6, 2013 at Sanofis U.S. headquarters in Bridgewater, NJ.

The BioNJ Diagnostics & Personalized Medicine Innovation Summit will bring together leaders from major global biotechnology and pharmaceutical companies, diagnostics companies, and emerging innovator companies to discuss the latest trends, developments and challenges in the evolution and adoption of personalized medicine. The all-day event will include company presentations, networking opportunities, and moderated panel discussions focused on research and commercialization challenges in diagnostics and personalized medicine.

Panna Sharma, CEO and President of CGI, will moderate a morning roundtable discussion that will offer a cross-industry perspective from thought leaders and operators in the frontline of driving personalized medicine. The panel will discuss trends and strategies that are emerging among leading companies in personalized medicine. Panelists include:

To learn more about the BioNJ Diagnostics & Personalized Medicine Innovation Summit, visit http://www.bionj.org/diagnostics-and-personalized-medicine-innovation-summit.

About Cancer Genetics, Inc.

Cancer Genetics, Inc. (CGI) is an emerging leader in DNA-based cancer diagnostics and servicessome of the most prestigious medical institutions in the world. Our tests target cancers that are difficult to diagnose and predict treatment outcomes. These cancers include hematological, urogenital and HPV-associated cancers. We also provide a comprehensive range of non-proprietary oncology-focused tests and laboratory services.

CGIs cutting-edge proprietary tests and state-of-the-art reference laboratory provide critical genomic information to healthcare professionals as well as biopharma and biotech. Our state-of-the-art reference lab is focused entirely on maintaining clinical excellence and is both CLIA certified and CAP accredited and has licensure from several states including New York State.

Founded in 1999 by world-renowned cytogeneticist Dr. R.S.K. Chaganti, the Company has been built on a foundation of world-class scientific knowledge and IP in solid and blood-borne cancers, and has established strong research collaborations with major cancer centers such as Memorial Sloan-Kettering, The Cleveland Clinic and the National Cancer Institute. For further information, please seewww.cancergenetics.com.

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Cancer Genetics to Sponsor and Host Roundtable at BioNJ Diagnostics & Personalized Medicine Innovation Summit

SEATTLE, WA--(Marketwired - May 14, 2013) - Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company, announced today that Dr. Steven Quay, Chairman, CEO & President, will speak and participate on the Diagnostics panel at the Sachs Associates Cancer Bio Partnering Forum on Wednesday, May 22, 2013, at the Westin Copley Place in Boston, Massachusetts. Dr. Quay's corporate presentation will take place from 11:00 a.m. to 11:15 a.m. and the Diagnostics panel will take place from 11:55 a.m. to 12:25 p.m. Eastern Time.

Dr. Quay commented, "The Sachs Associates Cancer Bio Partnering Forum is a unique event that brings together a prestigious group of thought leaders and business development executives in the cancer biology space to discuss the latest advances in cancer diagnosis and treatments. I appreciate the opportunity to present our ForeCYTE Breast Health Test and other breast health products and laboratory services and to discussing our plans to develop an intraductal therapy for treatment of ductal carcinoma in situ (DCIS) in order to prevent breast cancer. I look forward to a highly productive meeting."

About Atossa Genetics, Inc.

Atossa Genetics, Inc. (NASDAQ: ATOS), The Breast Health Company, is based in Seattle, WA, and is focused on preventing breast cancer through the commercialization of patented diagnostic medical devices and patented laboratory developed tests (LDT) that can detect precursors to breast cancer up to eight years before mammography, and through research and development that will permit it to commercialize treatments for pre-cancerous lesions.

The National Reference Laboratory for Breast Health (NRLBH), a wholly owned subsidiary of Atossa Genetics, Inc., is a CLIA-certified high-complexity molecular diagnostic laboratory located in Seattle, WA. The NRLBH provides the patented ForeCYTE Breast Health Test, a risk assessment test for women 18 to 73 years of age akin to the Pap Smear, and the ArgusCYTE Breast Health Test, a blood test for recurrence in breast cancer survivors that provides a "liquid biopsy" for circulating breast cancer cells and a tailored treatment plan for patients and their caregivers.

For additional information, please visit http://www.atossagenetics.com. You can also view a video about the ForeCYTE test here: http://vimeo.com/62214008.

Forward-Looking Statements

This press release is being issued for compliance with Regulation FD. 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, regulatory clearances, responses to regulatory matters, Atossa's ability to continue to manufacture and sell its products, the efficacy of Atossa's products and services, the market demand for and acceptance of Atossa's products and services, performance of distributors and other risks detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its registration statement on Form S-1 filed April 5, 2013, and periodic reports on Form 10-K and 10-Q, each as amended and supplemented from time to time.

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Atossa Genetics to Present at the Sachs Associates Cancer Bio Partnering Forum and Participate on the Cancer Tech Panel

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

Seattle Genetics, Inc. (SGEN) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplement to the Biologics License Application (sBLA) supporting the use of ADCETRIS (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma (HL) and systemic anaplastic large cell lymphoma (sALCL). The FDA is expected to take action on the application by September 14, 2013. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of HL and sALCL, that was granted accelerated approval by the FDA in August 2011 for relapsed HL and relapsed sALCL.

Our goal is to broaden the ADCETRIS U.S. labeling claims to provide both patients and physicians the opportunity to incorporate ADCETRIS into additional HL and sALCL treatment settings, said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. The FDAs acceptance of our sBLA submission is an important step towards making ADCETRIS available in the retreatment and extended duration setting, and we look forward to the regulatory outcome.

The sBLA is based on results from a phase 2 clinical trial with two treatment arms. One arm evaluated retreatment with ADCETRIS in patients who previously responded to treatment with ADCETRIS, then discontinued treatment and subsequently had disease progression or relapse. The other arm evaluated extended treatment with ADCETRIS beyond 16 cycles of therapy. The sBLA submission includes updated data sets from this phase 2 trial.

Preliminary data from this trial were previously reported at the 2011 American Society of Hematology (ASH) Annual Meeting and at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting. Highlights include:

Retreatment:

Extended duration of treatment:

ADCETRIS is currently not approved for retreatment and extended duration beyond 16 cycles of therapy in relapsed HL and sALCL.

About Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell generally expresses CD30. Systemic ALCL is an aggressive type of T-cell non-Hodgkin lymphoma that also expresses CD30.

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Seattle Genetics Announces ADCETRIS® (Brentuximab Vedotin) Supplemental BLA Accepted for Filing by the FDA