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Sera Prognostics Receives New York State Approval for PreTRM® Testing | ||
By: Nasdaq / GlobeNewswire - 12 Dec 2018 | Back to overview list |
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SALT LAKE CITY, Dec. 12, 2018 (GLOBE NEWSWIRE) -- Sera Prognostics, Inc., a women’s health company, announced today that the New York State Department of Health has issued a clinical laboratory permit for Sera to perform PreTRM® testing for pregnant women in the state of New York. The lab approval was based on the results of an on-site inspection and rigorous evaluation process. With this approval, Sera can now commercialize the PreTRM® test in New York, a very important health care market. New York’s Clinical Laboratory Reference System (CLRS) provides guidelines, quality control standards and procedures to be used by permit-holding clinical facilities that provide laboratory services to healthcare providers in the state. In recognition of the fact that CLRS has requirements that are equal to or more stringent than the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the program was granted exempt status by the federal Centers for Medicare and Medicaid Services (CMS) in 1995. With New York State approval of Sera’s laboratory and PreTRM® test (https://www.wadsworth.org/regulatory/clep/approved-labs), Sera is permitted to provide its innovative laboratory testing services for intended use by pregnant women in all states nationwide. “Sera is the only company to rigorously develop, validate, and receive state regulatory approval across the entire U.S. for its innovative PreTRM blood test. The PreTRM test objectively assesses the individual risk of premature birth by analyzing blood drawn early in pregnancy,” stated Greg C. Critchfield, M.D., M.S., chairman and chief executive officer of Sera Prognostics. “The approval by New York State is strong recognition of the quality and clinical utility of Sera’s PreTRM test. Sera is proud to be able to provide PreTRM’s important information to doctors and patients in New York State, to better inform earlier proactive decision-making.” Preterm birth affects approximately 1 in 10 pregnancies in the US1 and can result in both short- and long-term complications. The annual costs in the US healthcare system of managing prematurity and its complications were estimated at $31.5B2 in 2015. About Preterm Birth About the PreTRM® Test About Sera Prognostics, Inc. Company Contact: Media Contact for Sera Prognostics: 1 http://www.marchofdimes.org/mission/prematurity-reportcard.aspx |
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