Roche Granted FDA Emergency Use Authorization for Cobas SARS-CoV-2 & Influenza A/B Test

Roche (Basel, Switzerland) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a rapid version of its Cobas SARS-CoV-2 & Influenza A/B test.

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 collected from individuals suspected of a respiratory infection, and is not intended for the detection of Influenza C virus.

The test is designed to run on Roche’s benchtop Cobas Liat system, which is a fast, easy-to-use, compact PCR system designed for on-demand testing in point-of-care settings such as physician clinics, pharmacies, and hospital and satellite laboratories. The fully-automated analyzer with touchscreen guided operation is smaller than a shoebox and conveniently designed for space-challenged testing locations. Single assay runs allow time-sensitive testing and reporting, while its sealed-tube design eliminates operator contact with reagents or other chemicals.

The latest EUA for the Roche test gives the new option of conducting rapid testing in either point-of-care or clinical laboratory settings to detect and differentiate between the viruses. The rapid diagnostic, which gives results for single samples within 20 minutes, is the second EUA for the Roche combination test. Earlier this month, Roche had received EUA from the FDA for a version of the Cobas SARS-CoV-2 & Influenza A/B test designed to run on its Cobas 6800/8800 systems, which provide results in about three hours. This was also the FDA's fifth EUA for such a combination diagnostic amidst the approaching flu season.