Exosome Diagnostics Expands its Coverage Reach for EPI to an Additional 82 Million Covered Lives in the United States

Press Feb 23, 2018

Covered Lives Now Total Approximately 100 Million

Boston, MA – February 23, 2018 - Exosome Diagnostics, Inc. summarized the impact of a series of recent announcements about contracts to provide laboratory services and ExoDx® Prostate(IntelliScore) (EPI) testing to three major Preferred Provider Organizations in the United States. The PPOs include Three Rivers Provider Network, FedMed, Inc. and America’s Choice Provider Network. Together these networks provide access to 82 million members across the United States. 

"Executing these agreements clearly demonstrates the clinical value of our EPI test, our patented technology platform and our CLIA and ISO certified laboratory for developing and launching diagnostic tests for cancer and other diseases," said John Boyce, CEO and President of Exosome Diagnostics. "We are gratified by the growing acceptance of the value our EPI test offers for patient care by health plans and clinicians. We look forward to providing EPI to their network participants and to announcing additional coverage decisions in the first quarter."

PPOs are an important way millions of Americans get access to high quality and affordable care. The basis for pricing under PPO agreements has been a challenge for many companies. EPI has been priced on Medicare’s Clinical Lab Fee Schedule for 2018 and that provides a sound basis for pricing and coverage of our test within PPO networks. Together these plans have contracts with over 1,400 payers and 550,000 healthcare providers in the US. 

"Combining this announcement with the coverage decision announced by a major private payer on January 8th, EPI is well positioned for broad coverage in the US in 2018. The expansion of insurance coverage for EPI testing is a major focus for Exosome Diagnostics this year,” Boyce concluded.

About the EPI Test

The EPI test is a completely non-invasive, urine-based test designed to be used along with clinical assessment and other standard of care factors (including age, race and family history) to enable physicians to assess whether an individual patient presenting for an initial biopsy is at greater risk for high-grade prostate cancer. As a “rule out” test, it is designed to more accurately predict whether a patient presenting for an initial biopsy does not have high-grade prostate cancer and, thus, could potentially avoid the discomfort, complications and cost of an initial biopsy and, instead, continue to be monitored. EPI, which is intended for use in men 50 years or older with a prostate-specific antigen (PSA) result of 2-10ng/mL presenting for an initial biopsy, involves patients submitting a simple urine sample, without having to first undergo a digital rectal exam (DRE).

This test was evaluated and its performance characteristics determined by Exosome Diagnostics Inc. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. Exosome Diagnostics is certified under the Clinical Laboratory Improvement Amendments (CLIA) act of 1988 as qualified to perform high complexity clinical testing.

About Exosome Diagnostics

Exosome Diagnostics is a privately held company focused on developing and commercializing revolutionary biofluid-based diagnostics to deliver personalized precision healthcare that improves lives. The company’s novel exosome-based technology platform, ExoLution™, and point of care instrument for protein capture and analysis, Shahky™, can yield comprehensive and dynamic molecular insights to transform how cancer and other serious diseases are diagnosed, treated and monitored. Visit www.exosomedx.com to learn more.


David Clair, Investor Relations

(646) 277-1266