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Noridian Issues Draft LCD for GenomeDx Prostate Biopsy Genomic Classifier

NEW YORK (GenomeWeb) – GenomeDx Biosciences announced today that Medicare administrative contractor Noridian GBA has issued a draft local coverage determination for use of the firm's Decipher Prostate Biopsy genomic classifier in patients with very low and low-risk prostate cancer as defined by National Comprehensive Cancer Network guidelines.

These men are candidates for active surveillance and may be closely monitored rather than undergoing treatment, such as surgery, radiation, or hormone therapy, the company said. As described in the draft LCD, Decipher Prostate Biopsy has been demonstrated across multiple studies to predict the risk of critical clinical endpoints, such as metastasis, prostate cancer specific mortality, and high-grade disease. The test, which utilizes a 22-biomarker expression signature, is used to determine which prostate cancer patients are likely to have a good outcome by being closely followed and can avoid more aggressive treatments.

"We believe that use of Decipher Prostate Biopsy may result in improved health outcomes for men afflicted with prostate cancer," GenomeDx CSO Elai Davicioni said in a statement.

In July, San Diego-based GenomeDx received a draft LCD for the Decipher Biopsy prostate cancer genomic classifier from Medicare contractor Palmetto GBA, which similarly proposed to cover the test for patients with localized prostate cancer who are at very low and low risk for negative outcomes with active surveillance. In 2015, the firm also received Medicare coverage for its Decipher Prostate RP genomic classifier, which is indicated for use in patients with adverse pathological findings after surgery to remove the prostate.