Exosome Diagnostics, CareFirst partner to speed up coverage for diagnostic tests

Liquid biopsy player Exosome Diagnostics is partnering with CareFirst BlueCross BlueShield to create evidence development studies for the evaluation of its EvoDx tests.

The agreement is part of CareFirst’s HealthWorx program, under which it works with early-stage companies to bring new technology to its members that could improve healthcare and reduce costs. They will assess new tests using clinical outcomes and cost analyses, with the goal of speeding up coverage for products that have "measurable benefits for patient care," according to a statement.

Specifically, Exosome Diagnostics and CareFirst will work to demonstrate the clinical utility of the former’s tests, according to the statement. The pair will choose diagnostic tests for studies, the study endpoints and "the extent and qualifications of the providers participating in these studies."

"The technology assessment and coverage determination process have been significant challenges for companies with innovative molecular diagnostic tests," the companies said in the statement.

First, the pair will focus on Exosome Diagnostics’ ExoDx Prostate Intelliscore (EPI) test, which is designed to rule out high-grade prostate cancer in patients, sparing them from an invasive biopsy. Prostate-specific antigen (PSA) screenings return a "relatively high number" of false positives, resulting in men with benign cases of low-grade cancers undergoing uncomfortable biopsies, said CareFirst Chief Medical Officer Rahul Rajkumar, M.D.

"The success of our companion diagnostics business and the launch of our point of care diagnostic system are important components of that strategy," said Exosome Diagnostics CEO John Boyce in the statement. "Now our diagnostics business will benefit from CareFirst’s commitment to creating a better way to develop timely and informed decisions about which molecular diagnostic tests bring value for their members and providers. We look forward to working with CareFirst on the launch of future diagnostic and companion diagnostic tests in our pipeline."