Exosome Diagnostics, Inc. announced today that it has executed an agreement for coverage of its prostate cancer risk assessment test, ExoDx® Prostate(IntelliScore) or EPI with Three Rivers Provider Network, Inc. (TRPN) of Chula Vista, CA. Under this agreement EPI is now accessible to both TRPN members and their dependents.
TRPN is the largest and fastest growing preferred provider organization (PPO) network in the United States. “Insurance coverage for a novel test like EPI is an important consideration for patients and doctors,” said Tom McLain, Chief Operating Officer of Exosome Diagnostics. "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 other companies. However EPI being included on Medicare’s Clinical Lab Fee Schedule for 2018 provides a sound basis for covering and pricing our test.”
A PPO is a managed care organization of medical doctors, hospitals, and other health care providers who have agreed with an insurer or a third-party administrator to provide health care at reduced rates to the insurer's or administrator's clients. As the largest network of its kind, TRPN provides healthcare benefits for more than 100 million patients nationwide. Their network is currently comprised of more than 1.5 million provider locations and 200 payers. PPO networks like TRPN provide faster payment for newly launched tests, medical devices and pharmaceuticals while maintaining acceptable levels of reimbursement.
When this announcement is combined with the 2018 Medicare pricing announced on November 27th and the company’s ongoing evidence development collaboration with CareFirst BlueCross BlueShield, it positions EPI for broad coverage and utilization in the US within the next 12 months.
“The company’s goal in 2018, for its EPI test, is to make the test readily accessible to patients,” stated John Boyce, President and Chief Executive Officer of Exosome Diagnostics. "The company has built a strategy and is driving a coordinated effort to quickly expand insurance coverage for the test,” Boyce continued. “Coverage is important as it will make EPI readily available to doctors and patients who are relying on the test to make an informed decision about whether to proceed with a prostate biopsy,” stated Boyce. “Exosome has put in place the operational infrastructure to process the significantly increasing number of EPI samples sent to its CLIA lab and is confident of its ability to deliver highly sensitive results to doctors within a matter of days,” stated Boyce.
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, ShahkyTM, 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.
Attachments:
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/22b3055c-a103-4a79-b040-17755a3158d1
Attachments:
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/89b15b3d-a6ea-4029-ad3f-389dd2f2bc0d