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www.fdanews.com/articles/169561-genomedx-biosciences-prostate-cancer-test-now-covered-by-medicare

GenomeDX Biosciences’ Prostate Cancer Test Now Covered by Medicare

January 15, 2015

GenomeDx Biosciences said Wednesday that Medicare benefits administrator Palmetto GBA has issued a positive coverage policy for its Decipher prostate cancer genomic test. More than half of men diagnosed with prostate cancer are older than 65 and covered by Medicare.

Decipher is indicated for men who have had prostate surgery and are in danger of metastasis. Risk factors include positive surgical margins, pathological stage T3 disease and rising prostate-specific antigen. The Medicare policy covers men with these features who are weighing treatment options after a radical prostatectomy, GenomeDx said.

In multiple studies, Decipher showed improved accuracy compared with PSA, Gleason score and other factors in predicting the spread of cancer in men following prostate surgery. Sixty percent of men classified as high risk by traditional measures were reclassified as low risk by Decipher, and 98.5 percent of these had no metastasis within five years of surgery.

The test also impacted physicians’ treatment decisions, GenomeDx said, with recommendations changing up to 40 percent of the time based on results. This can reduce costs and spare patients the burden of side effects associated with further treatment, the company said. — Kellen Owings