Exosome Diagnostics expanding access EPI to 28 million
January 27, 2018 – BOSTON. Exosome Diagnostics, Inc., today announced that it has entered into a preferred provider network agreement with America’s Choice Provider Network (ACPN) based in Henderson, NV and Farmington Hills, MI. Under the terms of the agreement, more than 28 million ACPN members from across the U.S. will have access and coverage for ExoDx® Prostate(IntelliScore), or EPI, the company’s novel urine test developed to help reduce the significant number of unnecessary prostate biopsies.
ACPN is an independent, multi-specialty provider network accessed by over 1,400 payers that has developed proprietary network and technology to deliver consistent healthcare transactions, simplified claims adjudication processes, reasonable reimbursement arrangements and reliable healthcare access for all parties, including providers, payers and patients. More than 28 million Americans and 750,000 international lives have access to ACPN’s network through a client base consisting of Insurance Carriers, Third Party Administrators, Health and Welfare Funds, Employer Groups and Self-Insured Health Plans.
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.
SOURCE: Exosome Diagnostics