Cobas SARS-CoV-2 Nucleic acid test is authorised for use in asymptomatic and symptomatic people, delivering results within 20 minutes
Roche has received the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for cobas SARS-CoV-2 Nucleic acid test for use on its cobas Liat System.
It is the first real-time RT-PCR test designed to identify SARS-CoV-2 infection in symptomatic and asymptomatic individuals within 20 minutes, said the company.
The test is intended for use at a wide range of point-of-care settings and is planned to be commercialised in markets accepting the CE mark, from next month.
Roche Diagnostics Solutions point of care head Ian Parfrement said: “We learn more about Covid-19 every day and Roche continues to develop solutions that will help healthcare systems around the world slow and eventually defeat this pandemic.
“We are pleased that we can now provide a test to enable healthcare professionals to identify both asymptomatic and symptomatic infected individuals at the point of care.
“Preventing further spread of the virus is crucial for public health and the continued safe reopening of our communities worldwide.”
Roche said that people infected with the SARS-CoV-2 virus may not show symptoms of Covid-19, but can still spread the infection.
Its RT-PCR test can be used in screening asymptomatic people which is important in the fight against the virus and is said to cover a wide range of SARS-CoV-2 variant strains.
The cobas Liat System uses PCR technology to fully automate the testing process, simplify workflow and facilitate testing in various point-of-care settings, and deliver results within 20 minutes.
Recently, Roche has secured CE mark approval for its SARS-CoV-2 Antigen Self-Test Nasal, a rapid chromatographic immunoassay or lateral flow assay, for at-home testing.
Last month, the company has received the FDA EUA for its cobas SARS-CoV-2 Test, used on high-throughput cobas 6800/8800 Systems, to test asymptomatic individuals.
Roche claimed that in addition to the tests for SARS-CoV-2 & influenza A/B, influenza A/B & RSV, Strep A and C. diff, it has been developing assays for other infectious diseases.