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NCCN Updates Guidelines for Hereditary Colon Cancer Testing

SALT LAKE CITY, March 4, 2014 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today is pleased to note that the National Comprehensive Cancer Network (NCCN) has revised its medical guidelines to expand Lynch syndrome screening. Lynch syndrome is the most common cause of hereditary colon cancer in adults.

Myriad believes the new guidelines will dramatically expand the number of patients eligible for hereditary colon cancer testing, especially among at-risk asymptomatic patients for whom screening has historically been limited based upon prior guidelines and a lack of insurance reimbursement. Some of the key aspects of the new guidelines include:

  • A recommendation that all patients who meet a five percent or greater risk threshold for Lynch syndrome are appropriate for testing;
  • A recommendation against sequential testing for the five Lynch syndrome genes in lieu of panel testing; and
  • An acknowledgement that patients with cancer can proceed directly to sequencing tests without a complicated tissue screening algorithm.

"We view the expansion of guidelines to broaden access to Lynch syndrome screening as a major victory for patients and their families. It is the culmination of a significant amount of work by patient advocates and healthcare professionals to bring about this important advancement in guidelines," said Patrick Lynch J.D. M.D., professor in the Department of Gastroenterology at the University of Texas MD Anderson Cancer Center. "Our hope is that these guidelines are broadly accepted by the medical community, which would dramatically expand the number of at-risk, asymptomatic, patients who have access to the life-saving information associated with Lynch syndrome testing."

Myriad estimates that approximately 30 percent of newly diagnosed colorectal cancer patients, 100 percent of newly diagnosed endometrial cancer patients, and three percent of asymptomatic patients will now qualify for Lynch syndrome testing under the new medical guidelines. These estimates are based upon Myriad's research collaborations with multiple research institutions and through the development of the PREdiction model for Mismatch repair Mutations (PREMM1,2,6) model by Sapna Syngal M.D. at the Dana Farber Cancer Institute and Fay Kastrinos M.D. at Columbia University.

"Our experience is that restrictive and confusing hereditary colon cancer guidelines have limited patient access compared to those in hereditary breast and ovarian cancer. This is a major step to expand access to genetic testing for all patients at risk for hereditary colon cancer," said Mark Capone, president of Myriad Genetic Laboratories. "Myriad will continue to work with professional organizations to identify appropriate patients, especially as we launch our next generation test, Myriad myRisk Hereditary Cancer, which has been shown to detect over 60 percent more deleterious mutations than standard of care in patients at risk of hereditary colon cancer."

March is Colon Cancer Awareness Month

Myriad will be observing colon cancer awareness month in March by working closely with healthcare providers across the country to further raise awareness about testing for hereditary colon cancer. Additionally, the company is supporting several Colon Cancer Alliance Undy 5000 events this year, including two in March. The Sacramento event was Saturday, March 1 and the San Diego event is Saturday, March 8. To learn more about Undy 5000 visit: http://support.ccalliance.org/site/PageServer?pagename=undy_landing

"As we support the new NCCN guidelines, we also recognize there is need to educate patients and physicians about the risks of hereditary colon cancer and options for genetic testing," said Capone. "Colon Cancer Awareness month is the perfect time for people to ask if there are early, multiple or rare colon cancers that run in their family. If so, they may be at increased risk for cancer and should have a conversation with their physician."

About Lynch Syndrome

Lynch syndrome is a hereditary condition that dramatically increases a patient's risk for certain types of cancer including colorectal, gastric, endometrial, ovarian, and other cancers. Patients with a deleterious mutation in one of the five Lynch genes (MLH1, MSH2, MSH6, PMS2, and EPCAM) have up to an 82 percent lifetime risk of colorectal cancer and a 71 percent lifetime risk of endometrial cancer. The average age of diagnosis of a person with Lynch syndrome is 45, as compared to the average age of 72 for a person diagnosed with colon cancer in the general population. Genetic testing can detect harmful mutations allowing patients to take preventive steps such as more frequent colonoscopies, which can significantly reduce their risk of colon cancer.

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 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: www.myriad.com.

Myriad, the Myriad logo and Myriad myRisk Hereditary Cancer, are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign 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 the new guidelines dramatically expanding the number of patients eligible for hereditary colon cancer testing, especially at-risk asymptomatic patients for whom screening has historically been limited based upon prior guidelines and a lack of insurance reimbursement; expansion of guidelines broadening access to Lynch syndrome screening; broad acceptance of the guidelines by the medical community dramatically expanding the number of at-risk, asymptomatic patients who have access to the life-saving information associated with Lynch syndrome testing; estimates that approximately 30 percent of newly diagnosed colorectal cancer patients, 100 percent of newly diagnosed endometrial cancer patients, and three percent of asymptomatic patients will now qualify for Lynch syndrome testing under the new medical guidelines; the new guidelines being a major step to expand access to genetic testing for all patients at risk for hereditary colon cancer; the Company continuing to work with professional organizations to identify appropriate patients, especially as the Company launches its next generation test, Myriad myRisk Hereditary Cancer, which has been shown to detect over 60 percent more deleterious mutations than standard of care in patients at risk of hereditary colon cancer; the Company observing colon cancer awareness month in March by working closely with healthcare providers across the country to further raise awareness about testing for hereditary colon cancer; the Company supporting several Colon Cancer Alliance Undy 5000 events this year, including two in March; 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.

CONTACT: Media Contact: Ron Rogers (801) 584-3065 rrogers@myriad.com Investor Contact: Scott Gleason (801) 584-1143 sgleason@myriad.comSource:Myriad Genetics, Inc.