Roche nets FDA authorization for combination COVID-19 and flu test

Roche
Roche's high-throughput laboratory test may prove especially useful as the pandemic collides with the annual flu season, allowing healthcare providers to tell the difference between patients showing similar sets of respiratory symptoms from a single sample. (Roche)

Roche announced the launch of its second COVID-19 diagnostic of the week after securing an FDA authorization for a test that detects the novel coronavirus as well as influenza A and B.

The high-throughput laboratory test may prove especially useful as the pandemic collides with the annual flu season, allowing healthcare providers to tell the difference between patients showing similar sets of respiratory symptoms from a single sample.

Built for use on the company’s automated cobas 6800/8800 systems, the RT-PCR test is also available in Europe under the CE mark. In addition, running both coronavirus and flu diagnostics at the same time aims to help labs conserve testing resources. 

RELATED: Roche Diagnostics says COVID-19 tests helped offset 2020 losses in routine health checks

Earlier this week, Roche announced plans to ship 40 million antigen-based rapid coronavirus tests by the end of the month, starting in Europe. The point-of-care diagnostic aims to provide a result in 15 minutes and is being submitted to the FDA for review.

The company did not state a production goal for its SARS-CoV-2 and influenza A/B test, saying it plans to deliver “as many tests as possible within the limits of supply.”

Last quarter, Roche saw its first overall sales decline in nearly a decade—while posting a 61% increase in molecular diagnostic sales during the pandemic’s spread through the first half of 2020.

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