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GenomeDx Announces New York State CLEP Approval of Decipher Prostate Cancer Tests

Decipher Biopsy and Post-Op Now Widely Available to New York State Physicians and Patients

San Diego – June 29, 2017 – GenomeDx Biosciences, a leader in the field of urologic cancer genomics, today announced approval by the New York State Clinical Laboratory Evaluation Program (CLEP) of GenomeDx’s prostate cancer classifier tests, Decipher® Biopsy and Decipher Post-Op, which are genomic tests intended to improve clinical decision-making following biopsy or radical prostatectomy, respectively, in men with prostate cancer. With this approval, Decipher Biopsy and Post-Op are now widely available to physicians and patients in New York state.

The New York State Department of Health (NYSDOH) regulates and oversees clinical diagnostic laboratories that test specimens from New York state residents. The CLEP seeks to ensure the accuracy and reliability of test results in clinical laboratories located in New York state or accepting specimens from its residents. Prior to CLEP approval, Decipher Biopsy and Post-Op were available to New York state residents on a patient-by-patient basis through the non-permitted laboratory testing program administered by the NYSDOH. In addition to the CLEP approval, the GenomeDx laboratory has been accredited by the College of American Pathologists (CAP) and has Clinical Laboratory Improvement Amendments (CLIA) certification.

“Obtaining CLEP approval is a rigorous process, further demonstrating the robust performance of Decipher Biopsy and Decipher Post-Op,” said Doug Dolginow, M.D., chief executive officer of GenomeDx. “Now physicians and patients of New York state have the same unrestricted access to our genomic prostate tests as physicians and patients have in the rest of the United States, allowing them the ability to facilitate better decision-making at multiple stages of prostate cancer.”

About Decipher Cancer Classifier Tests and GRID®

GenomeDx’s Decipher prostate and bladder cancer classifier tests are commercially available genomic 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 Post-Op 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 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 genetic 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 is headquartered in Vancouver, British Columbia, and operates a clinical laboratory in San Diego, California.

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