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GenomeDx Prostate Cancer Tests Get New York State Approval

NEW YORK (GenomeWeb) – GenomeDx announced today that its prostate cancer classifier tests have been approved by the New York State Department of Health's (NYSDOH) Clinical Laboratory Evaluation Program (CLEP).

The approval covers GenomeDx's Decipher Biopsy and Decipher Post-Op tests, which use genomic data to improve clinical decision-making following biopsy or radical prostatectomy, respectively, in men with prostate cancer.

The NYSDOH had previously allowed the tests to be sold on a patient-by-patient basis through its non-permitted laboratory testing program, the company said. With the CLEP approval, the tests are now widely available to physicians and patients in New York.

"Obtaining CLEP approval is a rigorous process, further demonstrating the robust performance of Decipher Biopsy and Decipher Post-Op," GenomeDx CEO Doug Dolginow said in a statement. "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."

Earlier this year, GenomeDx researchers published data showing that Decipher Biopsy can predict development of metastasis after men receive standard radiation and androgen deprivation therapy.