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The agency cautioned test companies that the presence of mutations in the virus could lead to false negative results.
The agency identified three tests potentially impacted by known mutations, and said it will continue to monitor authorized assays.
Some tests that detect multiple SARS-CoV-2 genes are serendipitously signaling new viral variants while still effectively detecting infections.
The new guidance allows developers to use other transport media and sample types without first obtaining 510(k) clearance.
The agency provided the update on Wednesday in its weekly virtual town hall and on its FAQ page.
The Washington Post reports that the White House has approved new, stricter guidelines for seeking emergency authorization for a coronavirus vaccine.
The panel also said that if any nation does decide to allow germline genome editing, its use should be limited to preventing serious monogenic diseases.
The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.
The agency has provided new guidance for tests that can be used outside of a lab setting, as well as updated its guidance on a number of other topics.
The guidance suggests validating a five-sample pooling strategy, but notes that this may need to be adjusted depending on assay sensitivity and local prevalence.
In a letter, about two dozen researchers criticize the World Health Organization investigation into the origins of SARS-CoV-2 and call for a new inquiry, the Wall Street Journal reports.
National Geographic reports that nine great apes at the San Diego Zoo have been vaccinated against SARS-CoV-2.
Janet Woodcock, the acting commissioner of the US Food and Drug Administration, speaks with NPR about SARS-CoV-2 testing and vaccines in the US.
In Science this week: genetic study of kidney fibrosis implicates the SOX9-NAV3-YAP1 axis.