OPKO Plans to Address Draft Local Coverage Determination Published by Novitas Solutions for 4Kscore Test
Opko Health, Inc. (OPK)
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Source: GlobeNewswire
MIAMI, May 18, 2018 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (Nasdaq:OPK) today announced that Novitas Solutions, Inc. issued a draft local coverage determination (LCD) for the 4Kscore test®. The draft LCD is a proposed non-coverage policy for the 4Kscore test for Medicare and, prior to its effectiveness, is subject to a public comment period ending July 5, 2018. OPKO plans to submit comments during this time period. The 4Kscore test has been included in the National Comprehensive Cancer Network Guidelines® (NCCN) since 2015, and European Association of Urology Prostate Cancer Guidelines since 2016. Recommendations are based upon expert panels’ assessment of peer reviewed literature to provide clinical standards for prostate cancer care. Both guidelines recommend the 4Kscore test can be used as an aid in decision making before a first or repeat prostate biopsy in men with elevated PSA or other clinical symptoms. 4Kscore test has 95% sensitivity and 93% Negative Predictive Value for
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