Now at 110 Million Covered Lives in the United States
Waltham, MA – May 9, 2018 - Exosome Diagnostics, Inc. has continued to make significant progress in expanding contracts to provide laboratory services and ExoDx® Prostate(IntelliScore) (EPI) testing through both public and private payers in the United States. Contracts executed in March and April 2018 have increased total covered lives from 82 million to 110 million plan members across the United States. This increase is based on a series of coverage decisions from regional private payers where we are marketing our EPI test. This includes association member plans, independent community plans and state Medicaid programs.
"Expanding coverage with key regional payers is an important demonstration of the extensive clinical validation and clinical utility evidence for our EPI test" said John Boyce, CEO and President of Exosome Diagnostics. "We have invested time and resources into studies that prove EPI positively impacts patient care. These studies also show that EPI reduces cost of care by avoiding unnecessary biopsies and associated complications, as well as the overtreatment of low grade prostate cancer. These are factors that have been cited in numerous publications and in the U.S. Preventive Services Task Force Prostate Cancer Screening Final Recommendation issued yesterday. We are truly gratified by the growing acceptance of the value our EPI test offers for patient care by health plans and clinicians.”
The company is advancing contracting decisions with a number of additional payers across the United States and expects to announce additional coverage determinations over the remainder of 2018.
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.