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regulatory guidance

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.

With the US now awash in positive samples, assay developers seeking authorization will no longer be allowed to use contrived samples.

Needs to Work

With new guidance, the US Food and Drug Administration tightens its oversight of SARS-CoV-2 antibody tests.

The agency recognized that having some companion tests approved for a few but not all cancer drugs with the same molecularly defined indication is not optimal for patient care.

The agency provided an overview of its policies regarding COVID-19 test regulations, as well as additional color and clarification, in a webinar.

Test makers are preparing to ramp up production of new SARS-CoV-2 assays and designated testing systems in anticipation of increased demand.

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US Agricultural Research Service scientists have sequenced the genome of the Asian giant hornet.

A study of families explores how children transmit SARS-CoV-2, according to the Associated Press.

According to the Economist, pooled testing for COVID-19 could help alleviate strains on testing labs.

In Science this week: MIT researchers outline approach dubbed translatable components regression to predict treatment response among IBD patients.