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Roche Gets FDA Emergency Use Authorization for Rapid Coronavirus, Flu Test

NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization for a rapid version of Roche Molecular Systems' Cobas SARS-CoV-2 & Influenza A/B test.

The RT-PCR-based test is designed to simultaneously detect and differentiate SARS-CoV-2, influenza A, and influenza B in healthcare provider-collected nasopharyngeal and nasal swabs, or nasal swabs self-collected in a healthcare setting. The test is designed to run on Roche Molecular Diagnostics' benchtop Cobas Liat system, providing results for single samples within 20 minutes in either a point-of-care or clinical laboratory setting, according to the company.

Earlier this month, Roche announced that it had received EUA from the FDA for a version of the Cobas SARS-CoV-2 & Influenza A/B test designed to run on its Cobas 6800/8800 systems, which provide results in about three hours.

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.