The rapid molecular diagnostic test facilitates the qualitative detection of the viruses that are responsible for Covid-19, Flu A, Flu B, and respiratory syncytial virus (RSV) infections, from a single patient sample

geneXperttest

Cepheid has secured FDA EUA for Xpert Xpress CoV-2/Flu/RSV plus test. (Credit: Cepheid)

Molecular diagnostics company Cepheid has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Xpert Xpress CoV-2/Flu/RSV plus rapid molecular diagnostic test.

The rapid molecular diagnostic test facilitates the qualitative detection of the viruses, responsible for Covid-19, Flu A, Flu B, and respiratory syncytial virus (RSV) infections, from a single patient sample.

The new plus version of the test is said to offer a third gene target for SARS-CoV-2 detection to meet the challenge of future viral mutations.

Cepheid has designed the Xpert Xpress CoV-2/Flu/RSV plus test for use on any of the company’s more than 35,000 GeneXpert systems installed across the world. It helps to generate results in around 36 minutes.

Cepheid chief medical and technology officer Dr David Persing said: “This respiratory season, healthcare providers may encounter a range of viral infections with symptoms that overlap with Covid-19, including Flu A, Flu B, and respiratory syncytial virus.

“Having a fast and accurate test that is designed to detect current and future variants of the viruses that cause Covid-19 and influenza will become increasingly important.”

The company plans to start supplying the Xpert Xpress CoV-2/Flu/RSV plus test to US customers in the next few weeks.

In May 2019, Hologic and Cepheid have secured approval from the FDA for diagnostic tests for extragenital testing for chlamydia and gonorrhea.