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FDA Grants Emergency Use Authorization for OnsiteGene Molecular COVID-19 Test

NEW YORK — The US Food and Drug Administration this week granted Emergency Use Authorization for OnsiteGene's Hi-Sense COVID-19 Molecular Testing Kit 1.0.

The RT-qPCR-based assay is designed for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal, oropharyngeal, mid-turbinate nasal, anterior nasal, and nasal swab specimens, as well as nasal aspirates, nasopharyngeal wash/aspirates, and bronchoalveolar lavage specimens.

The test may only be performed by labs CLIA-certified to perform high-complexity tests, according to the FDA.

The Scan

Self-Reported Hearing Loss in Older Adults Begins Very Early in Life, Study Says

A JAMA Otolaryngology — Head & Neck Surgery study says polygenic risk scores associated with hearing loss in older adults is also associated with hearing decline in younger groups.

Genome-Wide Analysis Sheds Light on Genetics of ADHD

A genome-wide association study meta-analysis of attention-deficit hyperactivity disorder appearing in Nature Genetics links 76 genes to risk of having the disorder.

MicroRNA Cotargeting Linked to Lupus

A mouse-based study appearing in BMC Biology implicates two microRNAs with overlapping target sites in lupus.

Enzyme Involved in Lipid Metabolism Linked to Mutational Signatures

In Nature Genetics, a Wellcome Sanger Institute-led team found that APOBEC1 may contribute to the development of the SBS2 and SBS13 mutational signatures in the small intestine.