Exosome Diagnostics, Inc., announced today that it has executed an agreement to provide its prostate cancer risk assessment test, ExoDx® Prostate(IntelliScore), or EPI, through FedMed, Inc., a national Preferred Provider Organization (PPO) with 40 million members in the United States. FedMed is headquartered in Gaithersburg, MD.
Under the terms of the agreement, Exosome Diagnostics is designated as a FedMed provider. The company’s EPI test is now accessible to FedMed’s members and will be covered through their extensive payor network. FedMed is one of the country’s largest proprietary PPO networks, consisting of over 550,000 physicians, 4,000 hospitals and 60,000 ancillary care providers.
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.
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A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/5031430a-120b-4f4d-823d-aa44ea805e55
Attachments:
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/6cd94dce-59f1-4eae-bda8-4ebe1eadec93