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GenomeDx Prostate Cancer Test Lands Medicare Coverage

NEW YORK (GenomeWeb) – GenomeDx Biosciences today announced that national Medicare benefit administration contractor Palmetto GBA has issued a positive coverage policy for the firm's Decipher prostate cancer classifier.

Palmetto issued the policy through the MolDx program, which it runs for the Centers for Medicare and Medicaid Services. In October 2014, Palmetto issued a preliminary local coverage determination for Decipher on behalf of CMS.

Decipher is a genomic, RNA expression-based test that predicts cancer aggressiveness with an assay of 22 validated biomarkers associated with metastatic disease. In multiple published studies, the test has proved to be more accurate than PSA, Gleason score, and other clinical risk factors in predicting metastatic disease in men following prostate surgery, the firm said in a statement.

The test is used with men who have specific risk factors for cancer recurrence. The Medicare coverage policy covers men with prostate cancer who have these features and are weighing treatment options after a radical prostatectomy.

GenomeDx said that Decipher test results have the power to change physician treatment recommendations. In published clinical studies, 60 percent of men classified as high risk by traditional tools were reclassified as low risk by the Decipher test and 98.5 percent of them had no incidence of metastasis within five years of surgery.

The firm signed test-coverage agreements last June with Prime Health Services and last September with PPO MultiPlan.