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Noridian Issues Final LCD for Decipher Biosciences Prostate Cancer Test

NEW YORK – Medicare Administrative Contractor Noridian Healthcare Solutions has issued a final local coverage determination for Decipher Biosciences' Decipher Biopsy test for men with prostate cancer.

Noridian's decision aligns with Palmetto GBA's final LCD for the test, which covers the biopsy only under certain clinical conditions. Those conditions include a needle biopsy with localized adenocarcinoma of the prostate; formalin-fixed paraffin embedded (FFPE) prostate biopsy specimen with at least 0.5 millimeters of cancer length and favorable or unfavorable intermediate risk disease; life expectancy of at least 10 years; candidacy for definitive therapy; no pelvic radiation or androgen deprivation therapy before the biopsy; and monitoring for disease progression.  

The clinical-grade whole-transcriptome assay measures the expression of over 1.4 million RNAs and is performed on FFPE prostate cancer tumor tissue, with the results reported as a genomic classifier score based on gene expression using a machine learning algorithm.

Last month, CGS Administrators also aligned its coverage decision with Palmetto's. The Noridian decision goes into effect May 4, 2020.