Cepheid Receives CE Mark for Its Xpert Xpress CoV-2 Plus Test

Sunnyvale, Calif.-based Cepheid has received a CE mark for its Xpert Xpress CoV-2 Plus rapid molecular diagnostic test for detection of the virus that causes COVID-19.

The new “plus” version of the test includes a third conserved genetic target for SARS-CoV-2 detection to meet the challenge of future viral mutations. Conserved targets are those that remain relatively unchanged as a virus evolves, allowing the polymerase chain reaction (PCR) test to identify new variants.

Xpert Xpress CoV-2 Plus is authorized for general screening, including individuals without symptoms or reasons to suspect COVID-19 infection. It is designed for use on the company’s GeneXpert PCR equipment. The test can provide rapid detection of SARS-CoV-2 in as little as 20 minutes for positive results.

Cepheid plans to launch the test in Europe this month.