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NEW YORK – The US Food and Drug Administration on Tuesday released new guidance for Emergency Use Authorization for molecular-based laboratory developed tests (LDTs) detecting SARS-CoV-2. 

Under the guidance, molecular-based LDTs for qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens that are authorized for use by the developing laboratory can be performed, but only in the CLIA-certified laboratory in which the test was developed.  

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