Cepheid Gains Emergency Authorization for New Version of Its Xpert Xpress COVID-19 Test

Cepheid has received FDA Emergency Use Authorization (EUA) for its Xpert Xpress CoV-2plus rapid molecular diagnostic test for detection of the virus that causes COVID-19.

The “plus” version of the test, which incorporates a third genetic target for SARS-CoV-2, is designed to detect the existing and future viral mutations.

The test can provide positive SARS-CoV-2 results in 20 minutes using the company’s Cepheid GeneXpert automated molecular diagnostic system. 

The Xpert Xpress CoV-2plus test is authorized for screening asymptomatic individuals or those with reason to suspect COVID-19 infection.

Cepheid plans to begin shipping the product immediately.