Skip to main content
Premium Trial:

Request an Annual Quote

Cepheid, Roche Coronavirus Tests Get FDA Emergency Use Authorization

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for a PCR-based SARS-CoV-2 test developed by Cepheid and a serology test for the virus from Roche.

The FDA also last week reissued an EUA for Quest Diagnostics RC SARS-CoV-2 Assay to permit its use with pooled samples.

Cepheid's Xpert Omni SARS-CoV-2 test is designed to detect the N and E genes of the virus in upper respiratory specimens such as nasopharyngeal swabs, nasal swabs, and nasal wash samples collected by a healthcare provider. Samples are placed in the company's Xpert Omni SARS-CoV-2 cartridge, which run on its automated GeneXpert Omni System.

The test may be used by any lab CLIA-certified to perform moderate- or high-complexity tests, according to the FDA.

In late September, Sunnyvale, California-based Cepheid received FDA EUA for a multiplex SARS-CoV-2, influenza, and respiratory syncytial virus test.

Roche's Elecsys Anti-SARS-CoV-2 S is an electrochemiluminescence immunoassay intended for the qualitative and semiquantitative detection of antibodies to the SARS-CoV-2 spike protein receptor binding domain in serum and plasma. It runs on the Swiss company's line of Cobas E analyzers.

Use of the test is limited to labs CLIA-certified to moderate- or high-complexity tests, the FDA said.

The Quest Diagnostics RC SARS-CoV-2 Assay, which is performed using Roche's authorized Cobas SARS-CoV-2 RT-PCR test, was originally authorized in July for the detection of viral nucleic acid in nasal swab samples self-collected under the observation of a healthcare provider via telemedicine. The next month, the test's EUA was reissued to allow its use with nasal swab specimens self-collected without healthcare provider observation.

Under the latest EUA reissuance, Quest's assay may also be used with pooled samples containing up to six individual upper respiratory swab specimens collected by a healthcare provider or nasal swab specimens self-collected at home.

Use of the assay remains limited to labs designated by Secaucus, New Jersey-based Quest and CLIA-certified to perform high-complexity tests, according to the FDA.

The Scan

Foxtail Millet Pangenome, Graph-Based Reference Genome

Researchers in Nature Genetics described their generation of a foxtail millet pangenome, which they say can help in crop trait improvement.

Protein Length Distribution Consistent Across Species

An analysis in Genome Biology compares the lengths of proteins across more than 2,300 species, finding similar length distributions.

Novel Genetic Loci Linked to Insulin Resistance in New Study

A team reports in Nature Genetics that it used glucose challenge test data to home in on candidate genes involved in GLUT4 expression or trafficking.

RNA Editing in Octopuses Seems to Help Acclimation to Shifts in Water Temperature

A paper in Cell reports that octopuses use RNA editing to help them adjust to different water temperatures.