SALT LAKE CITY, Aug. 13, 2015 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that Noridian, the Medicare Administrative Contractor (MAC) for Myriad, has issued a final local coverage determination (LCD) for Prolaris®, Myriad's pioneering prognostic test for assessing the aggressiveness of prostate cancer. This decision follows a final LCD decision from Palmetto GBA on January 15, 2015.
The final LCD is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services website with an effective date of October 15, 2015 and provides Medicare coverage for prostate cancer patients defined as low and very low risk by the National Comprehensive Cancer Network (NCCN). The Medicare coverage decision extends reimbursement for testing to the approximately 60,000 patients diagnosed each year with localized prostate cancer in the United States who meet the criteria of a Gleason score ≤6 and serum prostate specific antigen (PSA) level <10 ng/ml.
"We are excited that Noridian has issued a final LCD for Prolaris, providing coverage for Medicare beneficiaries with localized prostate cancer," said Mark Capone, president and CEO, Myriad Genetics, Inc. "The decision is an important step in providing Medicare reimbursement for this life-saving test and will significantly increase patient access to Prolaris testing in the United States."
More than 220,000 new cases are diagnosed and 30,000 men will die from the disease each year, making prostate cancer the second leading cause of cancer death among men in the United States. In Dec. 2014, Myriad presented data at the Society of Urological Oncology meeting that showed Prolaris could save the healthcare system $6 billion over a ten-year time period. Also, data from the recently completed PROCEDE 1000 clinical utility study demonstrated that physicians changed their treatment decisions in 48 percent of cases based on results from the Prolaris test. Of these treatment changes, 73 percent were reductions in treatment, while 27 percent were increases in treatment.
"At last, doctors who care for men with prostate cancer have an objective test to accurately measure the aggressiveness of their patients' cancer," said Michael Brawer, M.D., vice president of Urology, Myriad Genetic Laboratories. "Physicians can use this information to tailor treatments based on patients' individual risk."
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease progression in prostate cancer patients. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease progression in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy. For more information visit: www.prolaris.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 is focused on strategic initiatives to grow existing markets, diversify through the introduction of new products, including companion diagnostics, and expand internationally. 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 Lung Cancer, BRACAnalysis CDx, HRD, Vectra and Prolaris 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 Medicare decision extending reimbursement for testing to approximately 60,000 patients diagnosed each year with localized prostate cancer in the United States; the LCD decision significantly increasing patient access to Prolaris testing in the United States; the use of Prolaris testing by doctors for men with prostate cancer as an objective test to accurately measure the aggressiveness of patients' cancer; the ability of Prolaris testing to save the healthcare system $6 billion over a ten-year time period; and the Company's strategic directives under the captions "About Prolaris" and "About Myriad Genetics." 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 or will not continue to increase at historical rates; risks related to our ability to transition from our existing to new testing services, including unexpected costs and delays; risks related to changes in the 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; 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 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 our 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.
Source:Myriad Genetics, Inc.