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CareFirst BCBS, Exosome Dx Partner on Evidence Development Studies

NEW YORK (GenomeWeb) – CareFirst Blue Cross Blue Shield and Exosome Diagnostics announced today that they have agreed to collaborate on clinical studies aimed at driving health plan coverage for molecular diagnostic products.

The deal marks the first CareFirst has signed as part of its HealthWorx program under which the payor works with early-stage companies to generate evidence demonstrating the clinical utility of their tests and technologies in order to accelerate the coverage determination process.

Under the terms of their agreement, CareFirst will be Exosome's preferred partner for conducting evidence development studies designed to demonstrate the clinical and cost-saving benefits of its diagnostic tests. The partners will mutually agree on the tests to be studied, the extent and qualifications of providers participating in the studies, and study endpoints. Exosome's recently launched ExoDx Prostate IntelliScore (EPI) has been selected as their initial focus.

EPI is a urine-based test that looks for three exosomal RNA biomarkers expressed in men with high-grade prostate cancer to help in the biopsy decision-making process. CareFirst and Exosome will offer the test through selected urology group practices in Maryland in order to generate new evidence to guide clinical practice and enable CareFirst's members and providers to make more informed diagnostic and treatment decisions.

"One of the challenges presented by prostate-specific antigen (PSA) cancer screenings is the relatively high number of false positives detected from PSA results, which often fall into a gray zone and require further testing through biopsies," CareFirst Chief Medical Officer Rahul Rajkumar said in a statement. "We are excited about the evidence to date and potential for [the] EPI test to better inform physicians and members' decisions on which course of action to pursue when facing a PSA result in the gray zone."

Exosome CEO John Boyce added that his company has been working to "address the revenue and reimbursement challenges and risk profile that have been associated with other novel molecular diagnostic test companies," and that its diagnostic business is expected to benefit from the HealthWorx alliance.