Skip to main content
Premium Trial:

Request an Annual Quote

Roche Receives FDA EUA for PCR-Based, Point-of-Care SARS-CoV-2 Test

NEW YORK – Roche announced on Friday that its RT-PCR-based Cobas SARS-CoV-2 nucleic acid test for use on the Cobas Liat system has received Emergency Use Authorization from the US Food and Drug Administration.

The test can return results in 20 minutes and can be used for screening both asymptomatic and symptomatic people. It is the first molecular, point-of-care test that has received EUA for detecting SARS-CoV-2 in asymptomatic people, the company said in a statement.

Roche said the test is for use at a variety of POC settings including emergency and primary care, physician offices, and screening locations. A Roche spokesperson said the price of the test usually depends on the specific contract with users.

The test will be available in the US and in countries accepting the CE mark in July, Roche said.

In February, Roche's Cobas Influenza A/B & RSV nucleic acid test received 510(k) clearance from the FDA for use on the Liat system. Last September, the firm received EUA for its Cobas SARS-CoV-2 & Influenza A/B test on the Liat system.

The Scan

Nucleotide Base Detected on Near-Earth Asteroid

Among other intriguing compounds, researchers find the nucleotide uracil, a component of RNA sequences, in samples collected from the near-Earth asteroid Ryugu, as they report in Nature Communications.

Clinical Trial Participants, Investigators Point to Importance of Clinical Trial Results Reporting in Canadian Study

Public reporting on clinical trial results is crucial, according to interviews with clinical trial participants, investigators, and organizers from three provinces appearing in BMJ Open.

Old Order Amish Analysis Highlights Autozygosity, Potential Ties to Blood Measures

Researchers in BMC Genomics see larger and more frequent runs-of-homozygosity in Old Order Amish participants, though only regional autozygosity coincided with two blood-based measures.

Suicidal Ideation-Linked Loci Identified Using Million Veteran Program Data

Researchers in PLOS Genetics identify risk variants within and across ancestry groups with a genome-wide association study involving veterans with or without a history of suicidal ideation.