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.
| WASHINGTON, March 2, 2020 /PRNewswire/ --
Statement attributable to: “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.” About AACC Media contacts: Molly Polen
SOURCE AACC |
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