Skip to main content
Premium Trial:

Request an Annual Quote

BioMérieux Coronavirus Test Gets FDA OK for Use With Pooled Samples

NEW YORK — The US Food and Drug Administration last week reissued an Emergency Use Authorization for a SARS-CoV-2 assay developed by BioMérieux subsidiary BioFire Defense to allow the test's use with pooled samples.

The BioFire COVID-19 test was first authorized in March for the detection of SARS-CoV-2 nucleic acid nasopharyngeal swabs in transport media, with results available within 45 minutes. Under the reissued EUA, the PCR-based test can now also be used with pooled samples containing up to eight nasopharyngeal swabs collected individually in transport media.

The testing of nonpooled samples can be done by any lab CLIA-certified to perform moderate- or high-complexity tests. The testing of pooled samples, however, is limited to Department of Defense labs that meet the requirements to perform high-complexity tests, according to the FDA.

The Scan

Genes Linked to White-Tailed Jackrabbits' Winter Coat Color Change

Climate change, the researchers noted in Science, may lead to camouflage mismatch and increase predation of white-tailed jackrabbits.

Adenine Base Editor Targets SCID Mutation in New Study

Researchers from the University of California, Los Angeles, report in Cell that adenine base editing was able to produce functional T lymphocytes in a model of severe combined immune deficiency.

Researchers Find Gene Affecting Alkaline Sensitivity in Plants

Researchers from the Chinese Academy of Science have found a locus affecting alkaline-salinity sensitivity, which could aid in efforts to improve crop productivity, as they report in Science.

International Team Proposes Checklist for Returning Genomic Research Results

Researchers in the European Journal of Human Genetics present a checklist to guide the return of genomic research results to study participants.