Exosome Diagnostics announced today that the largest private payor in the Mid-Atlantic region has reached a positive coverage decision for its ExoDx® Prostate(IntelliScore) assay. This decision is effective January 1, 2018 and covers the use of the test in assessing the risk for high grade prostate cancer in men being evaluated for initial and repeat prostate biopsies. The press release announcing the coverage decision is can be viewed by clicking here.
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™, can yield comprehensive and dynamic molecular insights to transform how cancer and other serious diseases are diagnosed, treated and monitored. Visit http://www.exosomedx.com to learn more.
Attachments:
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/6b559d7c-b5eb-4b6b-8e57-9a8cb3375c92
Attachments:
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/73d0b3c1-84b6-4cc1-aa73-0354688b8f8a