NEW YORK (GenomeWeb) – CareFirst Blue Cross Blue Shield said today that it will cover Exosome Diagnostics' ExoDx Prostate IntelliScore (EPI) prostate cancer test based on the results of an evidence development study launched last year.
In the ongoing study, 1,000 men scheduled for an initial prostate biopsy are being tested with EPI — 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. Urologists receive an EPI test report for half of the patients to help guide their treatment decisions, while the other half of the patients will be treated by the same urologists following the current standard of care without an EPI test result.
In an analysis of the first 500 patients, the biopsy rate for patients with an EPI report was 30 percent lower than for patients in the standard-of-care control group, CareFirst said. Data from both patient populations showed that EPI testing resulted in 39 percent fewer unnecessary biopsies, and an 83 percent compliance between EPI test results and biopsy decisions.
The EPI study is the first that CareFirst and Exosome are conducting under a partnership formed last year to conduct clinical studies aimed at driving health plan coverage for molecular diagnostic products, beginning with EPI. That alliance is also the first deal CareFirst signed as part of its HealthWorx program, under which the payor is working with early-stage companies to generate evidence demonstrating the clinical utility of their tests and technologies in order to accelerate the coverage determination process.
"While we will continue to monitor the members in the study, the positive results coupled with evidence from previous clinical trials led to our decision to cover the EPI test," CareFirst President and CEO Chet Burrell said in a statement. "This is just the type of advance that we are seeking to foster through our Healthworx program."