Industry Press Releases

GenomeDx Achieves Significant Medicare Milestone for Decipher Prostate Biopsy Genomic Classifier

Friday, Sep 21, 2018

GenomeDx Biosciences, a leader in the field of urologic cancer genomics, today announced that Noridian GBA, a Medicare Administrative Contractor (MAC), has issued a draft local coverage determination (LCD) for use of the Decipher® Prostate Biopsy genomic classifier in patients with very low and low NCCN (National Comprehensive Cancer Network) 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. The test 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. Notably, it is the only commercially available test in the US that measures risk of disease progression independent of clinical and pathological risk factors.

"We believe that use of Decipher Prostate Biopsy may result in improved health outcomes for men afflicted with prostate cancer," said Elai Davicioni, PhD, chief scientific officer of GenomeDx. "We commend Noridian GBA for taking this step to make this genomic test available for all Medicare beneficiaries."

The draft LCD, titled "MolDX: Decipher Biopsy 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 begins on October 4, 2018; following the comment period, 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.

GenomeDx has already received Medicare coverage for the Decipher Prostate RP genomic classifier for use in patients with adverse pathological findings after surgery to remove the prostate.

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 Prostate Biopsy is indicated for men with localized prostate cancer at diagnosis, Decipher Prostate 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.

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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. Decipher and Decipher GRID is a registered trademark of GenomeDx.
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Joleen Schultz