GenomeDx Announces Medicare Draft Local Coverage Determination (LCD) for Decipher Prostate Biopsy Genomic Classifier

SAN DIEGO, July 24, 2018 /PRNewswire/ -- GenomeDx Biosciences, a leader in the field of urologic cancer genomics, today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC), has issued a Draft local coverage determination (LCD) and completed the public comment period for use of the Decipher Prostate Biopsy genomic classifier in patients with very low and low NCCN risk prostate cancer. These men are candidates for active surveillance and may be closely monitored rather than undergoing treatment such as surgery, radiation, or hormone therapy.

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. It is the only commercially available test in the US that measures risk of disease progression independent of clinical and pathological risk factors. Decipher Prostate Biopsy is used by physicians to determine which patients are more likely to have a good outcome on active surveillance and thus may be spared immediate treatment.

"We currently have Medicare coverage for Decipher testing in men following radical prostatectomy, and are excited to proceed with Medicare in the coverage process for Decipher in men with very low and low NCCN risk prostate cancer," said Elai Davicioni, PhD, president and chief scientific officer of GenomeDx. "We believe that use of Decipher Prostate Biopsy will significantly improve the health and well-being of Medicare beneficiaries diagnosed with prostate cancer."

In 2015, GenomeDx received Medicare coverage for the Decipher Prostate RP genomic classifier for use in patients with adverse pathological findings after radical prostatectomy.

The Draft LCD, titled "Decipher Prostate Cancer Classifier Assay for Men with Very Low and Low Risk Disease", is posted on the Centers for Medicare and Medicaid Services (CMS) website. The public comment period was completed on July 19, 2018, and the remainder of Medicare's review process must be completed before the proposed LCD can be finalized and made effective. LCDs are subject to annual review by the MAC.

About Decipher Cancer Classifier Tests and GRID

GenomeDx's Decipher prostate and bladder cancer classifiers are clinical, commercially available oncology tests that provide a genomic assessment of tumor aggressiveness for individual patients. Decipher Biopsy is indicated for men with localized prostate cancer at diagnosis, Decipher RP is indicated for men after prostate removal surgery, and Decipher Bladder is indicated for patients being considered for neoadjuvant chemotherapy prior to bladder removal surgery. The Decipher tests are used by physicians to stratify patients into more accurate risk groups than determined by traditional diagnostic tools and to help determine which patients may be more likely to benefit from additional treatment.

The Decipher tests are derived from GenomeDx's Decipher Genomics Resource Information Database (GRID). GRID contains the genomic profiles of tens of thousands of tumors from patients with urological cancers, and is believed by GenomeDx to be the largest shared genomic expression database in urologic cancer as well as one of the world's largest global RNA expression databases using cloud-based analytics. Each tumor analyzed with a Decipher test adds new data to the GRID database, which is compiled into a Decipher GRID Profile that may reveal additional biological characteristics of the tumor for ongoing research purposes. Going beyond risk stratification, Decipher and GRID make genomic information accessible for researchers to predict responses to therapy better and to guide treatment more precisely. In addition, GRID is a platform for interactive research collaboration, and may enable more rapid discovery, development, commercialization and adoption of new genomic solutions for key clinical questions in cancer treatment.

Learn more at www.deciphertest.com and www.deciphergrid.com

About GenomeDx Biosciences

GenomeDx is reimagining the use of genomics as a platform for mass collaboration to improve patient treatment and outcomes through its currently available genomic tests for prostate and bladder cancer as well as potential future tests. GenomeDx has offices in Vancouver, British Columbia and San Diego, California.

Learn more at http://www.genomedx.com/

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SOURCE GenomeDx Biosciences