FDA grants EUA to Roche’s Covid-19 test for asymptomatic people
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FDA grants EUA to Roche’s Covid-19 test for asymptomatic people

19 May 2021 (Last Updated May 19th, 2021 14:45)

Roche’s cobas SARS-CoV-2 Test gets FDA EUA for asymptomatic Covid-19 detection. 

FDA grants EUA to Roche’s Covid-19 test for asymptomatic people
The aim of expanding coronavirus testing for asymptomatic use is to mitigate disease spread. Credit: Roche.

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Roche’s cobas SARS-CoV-2 Test for asymptomatic people and those with suspected Covid-19.

Authorised to be used on cobas 6800/8800 Systems, the real-time reverse transcription polymerase chain reaction (RT-PCR) test is indicated to qualitatively identify SARS-CoV-2 nucleic acids.

Test specimens can be self-collected anterior nasal swab samples obtained on-site under the surveillance of a healthcare worker or nasal, nasopharyngeal and oropharyngeal swab samples collected by healthcare workers.

The cobas SARS-CoV-2 test is indicated for use in people who are suspected of having Covid-19 as well as for asymptomatic individuals or those with further reasons to suspect the disease.

Roche noted that the EUA supports the US Centers for Disease Control and Prevention’s guidance to scale up Covid-19 testing to asymptomatic individuals. The aim is to mitigate the disease spread.

The authorisation is applicable to pooled specimens of up to six individual samples.

Roche diagnostics solutions molecular lab head Cindy Perettie said: “One of the key strategies to reduce Covid-19 transmission is to stop the silent spread of disease early.

“Expanding highly sensitive testing to include people who are at risk of exposure but do not show symptoms will help guide contact tracing, isolation and surveillance requirements, which are crucial for public health and the safe reopening of communities.”

The company noted that asymptomatic testing using this test is available in CE mark accepting countries.

In March, Roche launched a new SARS-CoV-2, research use only laboratory test to help monitor emerging mutations of coronavirus.

Separately, binx health has submitted a EUA application to the FDA for its CRISPR-based point-of-care (POC) Covid-19 test.

Named ‘binx io’, the test is a Clinical Laboratory Improvement Amendments-waived platform for molecular identification of chlamydia and gonorrhoea in approximately 30 minutes.

The company modified this single-use cartridge for testing RNA-based targets. Sherlock Biosciences’ CRISPR technology was combined with binx’s electrochemical detection to develop this Covid-19 testing tool.