Roche gains FDA Emergency Use Authorization for simultaneous COVID-19 / flu test
The cobas SARS-CoV-2 and Influenza A/B Test is the first commercial test for fully automated high throughput systems to detect and differentiate between SARS-CoV-2 and influenza viruses with a single sample, according to the Swiss biotech company.
While there are FDA-approved/cleared tests for influenza A and B viruses, there are no FDA-approved/cleared multiplexed tests for simultaneous detection and differentiation of SARS-CoV-2 and influenza A/B virus nucleic acids.
Thomas Schinecker, CEO, Roche Diagnostics, said: “With the approaching flu season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone.
“Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients.”
The test is for use on cobas 6800/8800 systems. The systems provide up to 96 results in around 3 hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an 8-hour shift.
The cobas SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A virus, and Influenza B virus in nasal or nasopharyngeal swab samples. Under the FDA Emergency Use Authorization, the test can be used when a healthcare provider suspects a respiratory viral infection like COVID-19. It is not intended for the detection of Influenza C virus.
The test is also available in markets accepting the CE mark.
In March Roche also received FDA EUA for a high-volume molecular test to detect SARS-CoV-2. In May, its COVID-19 antibody test received FDA EUA. In July it added a Rapid Antibody Test to its portfolio, with SD Biosensor as distribution partner, that allows the detection of antibodies against COVID-19 at the point of care.
Roche also plans to launch a SARS-CoV-2 Rapid Antigen Test at the end of this month.