Roche Receives EUA for its SARS-CoV-2 and Influenza A/B Test

September 4, 2020

This test simultaneously detects and differentiates between SARS-CoV-2, influenza A and B.

Roche announced today it had received an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its cobas SARS-CoV-2 & Influenza A/B Test.

This test offers the ability to detect and differentiate between SARS-CoV-2, influenza A and B.

“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,” Thomas Schinecker, CEO of Roche Diagnostics, said.

The company’s fully-automated cobas 6800/8800 Systems can provide up to 96 results in about 3 hours, and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an 8-hour period.

The test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for the detection of the aforementioned viruses in nasal or nasopharyngeal swab samples.

This test is also available in Europe.

Earlier this week, Roche announced it t was launching its SARS-CoV-2 Rapid Antigen Test in Europe at the end of September. That test provides results in 15 minutes and offers the possibility to assess and treat patientsmore efficiently.

“Testing continues to be an important focus for many countries. Especially in the upcoming flu season, it is important to know whether a person has SARS-CoV-2 or the flu to ensure the right course of treatment,” Roche’s Schinecker stated.