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FDA Releases New Information on Testing for SARS-CoV-2

The FDA recently made updates to its FAQs on Testing for SARS-CoV-2:

UPDATED the answer to the following question:

  • I am having trouble obtaining viral transport media (VTM) and a flocked nasopharyngeal swab to collect and transport patient samples. Are there alternatives that I can use?

ADDED the following question and answer:

  • What laboratories that had previously provided notification to FDA that they had developed and validated a diagnostic SARS-CoV-2 test under the policy outlined in Section IV.A of the Policy for Coronavirus Disease-2019 Tests have now been removed from that notification list because FDA has determined the test should no longer be used?
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NILA News

6/2/2025
No Appeal of FDA/LDT Lawsuit Decision!

4/3/2025
Summary of Court Decision Nullifying FDA Regulations for LDTs

4/1/2025
FDA's LDT Regulations Struck Down by Texas Court

   

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