Medicare Covers Prolaris Genetic Test for Low-Risk Prostate Cancer

On August 13, 2015, Medicare approved coverage of the Prolaris® test for men diagnosed with low-risk prostate cancer. The decision is the culmination of years of scientific discovery, research, and collaboration, and is an enormous step in improving patient care.

Every day, another 604 men in the United States are diagnosed with prostate cancer, and 82 die from the disease. Daunting statistics like these underscore the tremendous need for better tools to fight this deadly cancer. We know that most prostate cancers are slow growing; however, some grow quickly. The challenge always has been telling aggressive from nonaggressive cancer.

Prior to the genomics revolution, and for the last 50 years, physicians largely relied on the Gleason score, clinical grade and, after its development, PSA to evaluate the prognosis of men with prostate cancer. A Gleason score is determined based upon how cancer cells look under a microscope – the higher the score, the worse the prognosis. Although clinically useful, the Gleason score is subjective and imperfect. Fast forward to today.

Prostate Cancer Is Still No.1:

Prolaris is the first prognostic test to determine the aggressiveness of prostate cancer and has been studied in more than 10 clinical studies with thousands of patients. The test measures the activity level of 46 genes and provides physicians with precise objective information that is based on the tumor’s genetic profile. Simply put, men with a low Prolaris score have a low risk of disease progression and may be candidates for active surveillance, while those with a high score are at higher risk and may benefit from additional therapy.

The Prolaris test already is changing the equation in the fight against prostate cancer. Any physician who has treated prostate cancer knows all too well the personal and financial cost of undertreating aggressive cancer or over treating a slow-growing, indolent cancer. More work needs to be done to reduce the death toll from prostate cancer, but Medicare’s positive decision will help ensure that Medicare patients who need a Prolaris test will have access.

Mark Capone
CEO, Myriad Genetics