Myriad Genetics’ myPlan™ Lung Cancer Test Meets Primary Clinical Endpoint
Verification Study Published in the Journal Clinical Cancer Research
SALT LAKE CITY, Utah, Sept. 24, 2013 – Myriad Genetics, Inc. (NASDAQ: MYGN) today announced new data published in Clinical Cancer Research that showed the myPlan Lung Cancer test is a significant predictor of lung cancer death in patients with early-stage, resectable lung adenocarcinoma and may be a valuable tool for selecting which early-stage patients should be considered for additional post-surgical chemotherapy.
“Lung cancer remains one of the most difficult-to-treat cancers. New prognostic markers to guide treatment decisions in early-stage, non-small cell lung cancer are necessary to improve outcomes for patients,” said Edward S. Kim, M.D., co-author and chair of the Department of Solid Tumor Oncology and Investigational Therapeutics, Levine Cancer Institute, Carolinas HealthCare System, Charlotte NC. “In this verification study, the 31-gene cell cycle progression score was demonstrated to be a significant prognostic marker in resectable lung adenocarcinoma in that it stratifies patients risk more effectively than conventional clinical parameters. This new information will further improve our ability to define the most appropriate treatment plan for surgically-treated, lung-cancer patients.”
The purpose of this study was to investigate the significance of the myPlan Lung Cancer test as a predictor of survival in patients with early-stage lung adenocarcinoma in three independent data sets. The primary endpoint was overall survival as measured by disease related death within five years of surgery. Additionally, the study assessed the prognostic value of the score as compared to the conventional clinical variables of disease progression including age, stage of disease, gender, smoking status and tumor size.
The myPlan Lung Cancer test measured mRNA expression levels of 31 cell cycle proliferation genes and 15 housekeeping genes in stage I and II tumor samples from a total of 841 patients. The results showed that myPlan Lung Cancer consistently was the strongest independent predictor of 5-year disease survival and remained the dominant prognostic marker in the presence of conventional clinical variables. “myPlan Lung Cancer is an important new molecular diagnostic tool that will help physicians in predicting the aggressiveness of early-stage lung cancer in conjunction with conventional clinical parameters,” said Mark Capone, president of Myriad Genetics Laboratories. “Publication of these data is an important milestone as we prepare to launch myPlan Lung Cancer later this fiscal year.”
The full publication of this study is available on the Clinical Cancer Research web site at: http://clincancerres.aacrjournals.org/content/early/2013/09/18/1078-0432.CCR-13-0596.full.pdf+html
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: www.myriad.com.
Myriad, the Myriad logo, myRisk 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 Company’s myPlan Lung Cancer prognostic test as a valuable tool for selecting which early-stage patients should be considered for additional post-surgical therapy; the myPlan Lung Cancer test being an important new molecular diagnostic tool that will help physicians in predicting the aggressiveness of early-stage lung adenocarcinoma in conjunction with conventional clinical parameters; the anticipated launch of the myPlan Lung Cancer test this fiscal year after completion of the final validation; 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.