On May 25, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has issued a positive final Local Coverage Determination (LCD) to expand Medicare coverage of the Prolaris test (Press release, Myriad Genetics, MAY 25, 2017, View Source [SID1234519305]).
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Today’s decision extends coverage to Medicare beneficiaries with favorable intermediate risk prostate cancer and builds on a prior decision that provided coverage for men with low- and very low-risk prostate cancer. The new LCD is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services (CMS) website with an effective date of July 10, 2017. Prolaris is the first and only genetic test to receive Medicare coverage for favorable intermediate and low- or very low-risk prostate cancer in the United States.
"We are excited that the MolDX program has expanded Prolaris coverage to the thousands of Medicare beneficiaries with favorable intermediate risk prostate cancer," said Mark C. Capone, president and CEO, Myriad Genetics. "The coverage decision is another important step to make sure the Prolaris test is broadly accessible to the patients who need it."
Of the newly diagnosed patients with prostate cancer, approximately 20 percent will be favorable intermediate risk prostate cancer, which is defined by National Comprehensive Cancer Network (NCCN) as a Gleason score of 3+4 or less, a percentage of positive biopsy cores less than 50 percent and, at most, one NCCN determinant of intermediate-risk prostate cancer. When combined with the previous Medicare coverage decision, more than 70 percent of Medicare patients with prostate cancer will have access to the Prolaris test.
"It is clinically challenging to determine how best to treat men with favorable intermediate risk prostate cancer. Our goal is to provide physicians with genetic information and help them tailor treatments based on patients’ individual risk profiles." said Michael Brawer, M.D., senior vice president of Urology, Myriad Genetic Laboratories. "The Prolaris test accurately measures the aggressiveness of prostate cancer and give’s both the patient and physician the confidence to make appropriate medical management decisions."
About Prolaris
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics to quantify the aggressiveness of prostate cancer and help guide patient care. Prolaris is the only prognostic signature for prostate cancer which has been validated to predict 10-year prostate cancer specific mortality in an untreated patient cohort allowing men to make treatment decisions prior to surgical intervention. Additionally, Prolaris has been extensively validated on its ability to also predict patients that are at higher risk for biochemical recurrence and metastases. Studies have shown that following the Prolaris test almost two-thirds of men are good candidates for more conservative patient management, leading to lower treatment associated side effects and lower overall healthcare costs. For more information on how the Prolaris test can provide information to help decision-making in managing an individual’s localized prostate cancer visit www.Prolaris.com.