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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.
While new ways to carry out pool testing for SARS-CoV-2 abound, questions remain about sensitivity issues and the regulation of such tests.
The move is intended to increase testing for COVID-19 and may help conserve resources, which were a major problem during the height of the pandemic.
The template describes the data and information that should be submitted for EUA of collection kits or tests with a home self-collection component.
Russia says its candidate SARS-CoV-2 vaccine has a very high efficacy rate in an initial analysis of clinical trial data, according to the Financial Times.
Wired reports on a microbial analysis of sketches drawn by Leonardo DaVinci.
A new survey explores coronavirus vaccine hesitancy among Black and Latino individuals, the Washington Post reports.
In Nucleic Acids Research this week: the Aging Atlas database, a database of human metagenome-related metadata, and more.