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Exosome Diagnostics Launches Evidence Development Study for Prostate Cancer Test

NEW YORK (GenomeWeb) – Exosome Diagnostics and Chesapeake Urology announced today that they have initiated an evidence development study designed to drive health plan coverage for Exosome's ExoDx Prostate IntelliScore (EPI) prostate cancer test.

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. Last month, Exosome partnered with CareFirst Blue Cross Blue Shield to generate data demonstrating the clinical utility of different molecular diagnostics — beginning with EPI — in order to accelerate the coverage determination process.

As part of that alliance, Exosome will work with Chesapeake Urology on a prospective clinical study in 1,000 patients being evaluated for initial prostate biopsy. Half of the patients will be tested with EPI, while the other half will be treated based on the current standard of care. Study endpoints include the reduction in biopsies for patients with a reported EPI test result, urologist and patient satisfaction with EPI, and economic savings based on use of the EPI test result.

"This clinical study with [Exosome] and Chesapeake Urology advances our efforts to implement medical best practices in a time of increased focus on better patient outcomes, quality care, and cost-effective delivery of medical services," CareFirst Chief Medical Officer Rahul Rajkumar said in a statement.

"We are committed to overcoming the revenue and reimbursement challenges that have limited patient access to novel liquid biopsy tests like EPI up until this point," Exosome CEO John Boyce added in the statement. "Partnering with Chesapeake Urology …  is an incredible opportunity to demonstrate the value of exosome based liquid biopsy tests for clinical care."