Myriad Adds to Scientific Evidence for the myPlan(R) Lung Cancer Prognostic Test
SALT LAKE CITY, Sept. 9, 2015 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN) today presented two posters on its myPlan® Lung Cancer prognostic test at the International Association for the Study of Lung Cancer (IASLC) 16TH World Conference on Lung Cancer being held in Denver, Colo.
The first study showed that the myPlan Lung Cancer test identified more patients with Stage IB lung cancer who are at risk for disease progression than were identified with National Comprehensive Cancer Network (NCCN) high-risk factors alone. The second study highlighted the successful analytical validation of the myPlan test, which demonstrated very high analytical precision.
"We use relatively crude categories of stage that were developed over 60 years ago to decide when to give chemotherapy. There is no routine assessment of the biology of the tumor, which we now know is a primary determinant of the risk of recurrence and cancer death," said Daniel Oh, M.D., Keck School of Medicine, University of Southern California. "Several validation studies from premiere cancer centers in this country have been presented and published that demonstrate the efficacy of myPlan Lung Cancer. I believe that the test is an important step forward in improving outcomes of lung cancer patients and allows a more rational approach to tailoring the treatment of our patients."
Below are details of the myPlan Lung Cancer studies that were highlighted at #WCLC2015.
Poster Presentation: P3.04-074.
Title: Prognostic Multigene Molecular Assay Might Improve Identification of Pathologic Stage IB Lung Adenocarcinoma Patients at Risk for Recurrence.
Date: Wednesday, Sept. 9, 2015: 9:45 to 10:45 a.m. and 3:45 to 4:45 p.m.
This study compared Stage IB patient risk as assessed by the myPlan Lung Cancer prognostic test score, which is a combination of cell cycle progression score and pathologic stage, versus NCCN high-risk features. Of the 279 Stage IB patients evaluated, 183 (65.6 percent) were designated high risk by the myPlan Lung Cancer test. Of these high-risk patients, less than 50 percent had three or more high-risk features as defined by NCCN guidelines. This study demonstrated that the myPlan Lung Cancer test can identify high-risk patients that would have been otherwise designated as low risk according to NCCN pathological features. Importantly, in the Stage IB population, the myPlan test provided quantitative risk information above that determined by current NCCN high-risk features. Patients with resected Stage I lung adenocarcinoma and a high myPlan Lung Cancer score may be candidates for adjuvant therapy to reduce cancer-related mortality.
Poster Presentation: P3.04-084.
Title: Analytical Validation of a Proliferation-Based Signature Used as a Prognostic Marker in Early-Stage Lung Adenocarcinoma.
Date: Wednesday, Sept. 9, 2015: 9:45 to 10:45 a.m. and 3:45 to 4:45 p.m.
This study successfully validated the analytical performance of the myPlan Lung Cancer test using formalin-fixed paraffin embedded (FFPE) tissue samples from patients with lung cancer by assessing precision, dynamic range and RNA input requirements. The results showed that the test had a standard deviation of 0.06 score units, which is only one percent of the clinical range of scores, and demonstrates that the myPlan Lung Cancer test is highly reproducible. The positive results from this study form an important component of the analytical validation section in our reimbursement dossier.
About Myriad myPlan® Lung Cancer
Myriad myPlan Lung Cancer is a molecular prognostic test that measures the expression levels of cell cycle progression genes to provide an accurate assessment of cancer aggressiveness in patients with early-stage non-small cell lung adenocarcinoma. For more information visit: https://www.myriad.com/products-services/lung-cancer/myplan-lung-cancer/.
About Myriad Genetics
Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries 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 related to the ability of the myPlan Lung Cancer test to identify significantly more patients with Stage IB lung cancer who are at risk for disease progression; the analytical validation and precision of the myPlan Lung Cancer test; the belief that the test is an important step forward in improving outcomes of lung cancer patients and allowing a more rational approach tailoring the treatment of patients; and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current 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 set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers' reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical 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 pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over 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 our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products 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 or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical 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 in our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2015, which has been 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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