Genomic Health, Inc. (Nasdaq: GHDX) today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has issued its final local coverage determination (LCD) approving coverage of the Oncotype DX® prostate cancer test for qualified Medicare patients throughout the United States.
"With Medicare's coverage, each year, nearly 60,000 prostate cancer patients and their physicians will now have the opportunity to make more optimal treatment decisions based on the unique biological information revealed by the Oncotype DX Genomic Prostate Score," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "This marks an important milestone in our work to expand the impact of our Oncotype DX platform to meet a significant need for prostate cancer patients and represents a large growth opportunity for Genomic Health."
More than 220,000 men are diagnosed with prostate cancer each year in the United States alone. The Medicare coverage decision extends reimbursement for Oncotype DX testing to prostate cancer patients defined as low- and very low-risk by the National Comprehensive Cancer Network (NCCN), who are eligible based on clinical and pathological factors such as prostate-specific antigen (PSA) and Gleason score. The effective date for Medicare coverage will be after the 45-day notice period according to Palmetto GBA's process.
With 14 prostate cancer studies that have included more than 2,000 patients, Oncotype DX is the only genomic test that has been validated to predict both near- and long-term outcomes, and addresses the most clinically actionable question of adverse pathology remaining in the prostate to enable more precise patient risk stratification and better informed treatment decisions.
"More than 50 percent of newly diagnosed men have low-risk prostate cancer that is unlikely to spread, yet a majority of them receive immediate aggressive treatment resulting in unnecessary surgery and radiation," said Phil Febbo, M.D., chief medical officer, Genomic Health. "A recently published multi-center review of patient charts showed a relative increase of 56 percent in the use of active surveillance in patients who received their Oncotype DX GPS compared to patients from the same practices with similar risk factors who were not tested."