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AACC Statement on New FDA Guidance that Allows Certified Labs to Perform Coronavirus Testing


Statement attributable to:
Carmen L. Wiley, PhD
President, American Association for Clinical Chemistry

“AACC thanks the FDA for being responsive to the concerns of the clinical laboratory community and amending the coronavirus guidance to allow CMS-certified labs to develop and implement new tests for coronavirus prior to FDA approval. Regulated under the Clinical Laboratory Improvement Amendments (CLIA), these laboratories already develop, validate, and perform in-house tests for serious public health conditions such as influenza and prescription drug monitoring, and have the knowledge and expertise to create and validate the tests so that patients are tested for coronavirus quickly and accurately. We look forward to continuing to work with the FDA to ensure that patients receive timely, accurate tests that will ensure earlier diagnosis and better care.”


Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit

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