The General Services Administration (GSA) announced it has secured a 10-year reimbursement contract with Exosome Diagnostics laboratory, a Bio-Techne brand, covering its ExoDx Prostate (EPI) test for men. The contract will make EPI available as a reimbursed test to approximately 9 million additional men working in more than 140 government entities including all divisions of the armed forces, the VA, and members of the U.S. Senate and House of Representatives.
“We are very pleased that GSA has joined a growing list of payors and will now be reimbursing for the ExoDx Prostate Test,” said Chuck Kummeth, president and CEO of Bio-Techne, in a press release. “The benefits of this test are increasingly resonating with both patients and payors and we look forward to continuing to scale this game-changing technology.”
In June last year, the exosome-based prostate cancer screening test received Breakthrough Device Designation, a process within the FDA designed to provide an accelerated approval track for the test. EPI is currently included in NCCN prostate cancer testing guidelines for early detection in both initial and repeat biospsies.
The test is performed by Exosome Diagnostics, a Bio-Techne brand, in its CLIA, ISO, NY certified and CAP-accredited laboratory located in Waltham, MA. Bio-Techne acquired Exosome Diagnostics in June, 2018 for $575 million.
The EPI test is a risk assessment tool that assists physicians and their patients with determining if a prostate biopsy is needed when presented with an ambiguous PSA test result, which reduces complications from unnecessary and invasive procedures.
“Determining which patients need prostate biopsy continues to be a challenge for urologists and patients. We need better diagnostic tools, like a prostate carcinoma exosome test, which has the potential to assist in the physician-patient shared decision for prostate biopsy,” Said Jeffrey A. Jones, M.D., OCL deputy executive for Inpatient Services, chief of urology for OCL/MEDVAMC, and a professor at Baylor College of Medicine. “Many patients could benefit from a non-invasive urine test, such as the ExosomeDx Prostate test, to enhance the prostate biopsy decision-making with more confidence. I look forward to such diagnostic tools being available in the VA Healthcare system for U.S. veterans.”