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Eli Y. Adashi & I. Glenn Cohen, SARS-CoV-2 Laboratory-Developed Tests, JAMA (2022).

Abstract: On November 15, 2021, the US Department of Health and Human Services (HHS) rescinded a Trump-era policy that had directed the US Food and Drug Administration (FDA) to discontinue the premarket reviews of laboratory-developed tests (LDTs), including those for SARS-CoV-2.1 In a statement detailing the reversal, HHS Secretary Xavier Becerra noted that the policy “limited FDA’s ability to address certain problematic COVID-19 tests.”1 Secretary Becerra also noted that restoring the integrity of the regulatory process required that the FDA reinstate its “longstanding approach” to the oversight of the LDTs.1 Given the ever-growing demand for LDTs for detecting SARS-CoV-2, the restoration of integrity to the FDA review process could not be more timely. In this Viewpoint, we review the regulatory oversight of the LDTs, discuss its recent policy permutations, and explore potential future considerations.