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Palmetto Issues Draft LCD for GenomeDx Prostate Cancer Genomic Classifier

NEW YORK (GenomeWeb) – Medicare contractor Palmetto GBA has issued a draft local coverage determination (LCD) for GenomeDx Biosciences' Decipher Biopsy prostate cancer genomic classifier.

In the draft LCD, Palmetto proposes to cover the genomic classifier for patients with localized prostate cancer who are at very low and low risk for negative outcomes with active surveillance, according to National Comprehensive Cancer Network guidelines. Decipher Biopsy, which utilizes a 22-biomarker expression signature, is intended to be used to determine which prostate cancer patients are likely to have a good outcome by being closely followed and can avoid more aggressive treatments.

The public comment period for the draft LCD ended July 19. After the remainder of the review process completed, Palmetto will issue a final LCD, GenomeDx said in a statement.

GenomeDx also markets a genomic classifier called Decipher RP for men who have undergone prostate removal surgery. The company received Medicare coverage for this test in 2015 for use in patients with indications suggesting they're at high risk of recurrence following radical prostatectomy.