By GlobeNewswire, October 29, 2013, 07:05:00 AM EDT
Test Accurately Identifies Which Patients May Need Post-Surgical Chemotherapy
SALT LAKE CITY, Oct. 29, 2013 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that it has launched a new prognostic test, Myriad myPlan Lung Cancer, for patients diagnosed with early-stage lung adenocarcinoma. myPlan Lung Cancer is an RNA expression panel of 31 cell-cycle-progression genes, in combination with tumor staging information, to determine a patient's risk of dying from lung cancer within five years.
The myPlan Lung Cancer test has been extensively studied in more than 1,500 patients. In these studies, myPlan Lung Cancer was shown to be significantly predictive of five-year lung cancer mortality and considerably more predictive than tumor staging information alone. In a large validation study presented at the IASLC annual meeting, patients with a high-risk myPlan Lung Cancer score had nearly twice the rate of lung cancer deaths (35 percent) than patients with a low-risk score (18 percent). These findings build on data published in Clinical Cancer Research that showed the myPlan Lung Cancer test is the strongest independent predictor of survival in patients with early-stage lung cancer as compared to the conventional clinical variables of disease progression including age, stage of disease, gender, smoking status and tumor size.
"Post-surgical treatment decisions for early-stage lung cancer patients are largely guided by tumor staging. However, the prognostic power of tumor stage alone is limited and there remain unacceptably high mortality rates for this patient population," said Mark C. Capone, president of Myriad Genetics Laboratories. "Myriad myPlan Lung Cancer is a powerful new prognostic test that stratifies patients based on their risk of lung cancer-related, five-year mortality. Our test will empower physicians to know with confidence which patients should receive surgery alone versus those who may need more aggressive therapy."
Myriad myPlan Lung Cancer is being launched in a phased approach beginning with an early-access, clinical-experience program to medical and scientific thought leaders, followed by a full commercial launch in calendar year 2014. myPlan Lung Cancer will be sold through Myriad's own specialty sales force to assist physicians in providing their lung cancer patients with the most appropriate healthcare management. myPlan Lung Cancer has a list price of $3,400.
Myriad myPlan Lung Cancer is the second molecular diagnostic test launched by Myriad this fiscal year. In September, the Company launched Myriad myRisk™ Hereditary Cancer, a new multi-gene diagnostic test for eight major hereditary cancers including breast, colorectal, ovarian, endometrial, pancreatic, prostate, gastric and melanoma.
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 myPlan Lung Cancer, 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 Myriad myPlan Lung Cancer being launched in a phased approach beginning with an early-access, clinical-experience program to medical and scientific thought leaders, followed by a full commercial launch in calendar year 2014; Myriad myPlan Lung Cancer being sold through Myriad's own specialty sales force to assist physicians in providing their lung cancer patients with the most appropriate healthcare management; Myriad myPlan Lung Cancer 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; and the Company's strategic directives under the caption "About Myriad Genetics". These "forward-looking statements" are management's present expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and companion diagnostic services may decline or will not continue to increase at historical rates; risks related to changes in the governmental or private insurers reimbursement levels for our tests; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and companion diagnostic services tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; risks related to public concern over our genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to increased competition and the development of new competing tests and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents; risks related to changes in intellectual property laws covering our molecular diagnostic tests and companion diagnostic services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.
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Source: Myriad Genetics, Inc.