NEW YORK – Bio-Techne on Wednesday said that the General Services Administration (GSA) has awarded a 10-year reimbursement contract to its Exosome Diagnostics laboratory for the ExoDx Prostate (EPI) test.
The contract took effect today, providing 9 million additional men access to the urine-based genomic EPI test for early detection of prostate cancer, the firm said.
Overall, the decision impacts more than 140 government entities, including the VA Healthcare system and military branches such as the Army, Navy, Air Force, and Marines, as well as the US Senate and House of Representatives and others.
Bio-Techne's EPI test is a risk assessment tool that assists physicians and their patients with determining whether a prostate biopsy is needed when patients present with an ambiguous PSA test result.
Bio-Techne's Exosome Diagnostics performs the test in a CLIA-, ISO-, and New York-certified and CAP-accredited laboratory in Waltham, Massachusetts.
The liquid biopsy test has received FDA Breakthrough Designation and has been included in the NCCN guidelines for early detection in men for both initial and repeat biopsy.
Last October, Minneapolis-based Bio-Techne said that Medicare Administrative Contractor National Government Services issued a final Local Coverage Decision for EPI. In July, the firm said it had received a clinical laboratory permit from the New York State Department of Health to provide its liquid biopsy test in the state.