Myriad's Prolaris test included in NCCN Guidelines for men with localized prostate cancer

Prolaris Test for Use in All Men with Localized Prostate Cancer

Myriad Genetics, Inc. (Nasdaq: MYGN) today announced that its Prolaris test has been included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) for all men with localized prostate cancer, regardless of their risk category. The NCCN guidelines provide treatment recommendations to ensure that patients receive diagnostic treatment and services that are likely to improve clinical outcomes.

Specifically, the updated NCCN guidelines include the use of the Prolaris test to help patients better assess their risk of disease specific mortality and biochemical recurrence. Importantly, Prolaris is supported by seven peer-reviewed publications and is the first and only genetic test for prostate cancer that is:

• Proven and validated based on gold standard clinical endpoints of disease recurrence and prostate cancer-specific death in untreated men, thus identifying men who can safely forgo initial surgery or radiation and be managed with active surveillance;
• Proven in clinical utility studies to change treatment recommendations for up to 65 percent of prostate cancer patients in all risk categories, which may enhance adherence to recommended treatments; and
• To receive a draft local coverage determination (LCD) for Medicare reimbursement for low-risk patients.

“We are excited that the NCCN has included Prolaris as an important prognostic test to help inform men with localized prostate cancer about the aggressiveness of their disease and to help their physicians tailor therapy based on a more accurate assessment of risk,” said Chip Parkinson, general manager of the Urology Business Unit at Myriad. “Prolaris is the only test proven to accurately predict mortality in men with localized prostate cancer, and the only biomarker validated in studies of patients who were untreated. This means that men can be confident in choosing active surveillance with Prolaris.”

Earlier this month, Myriad announced that Palmetto GBA, the Medicare administrative contractor, issued a draft LCD for the Prolaris test for patients with low-risk prostate cancer. Once finalized, the LCD will establish coverage policy for Medicare beneficiaries throughout the United States.