On May 12, 2022, Cepheid announced it had received Emergency Use Authorization from the U.S. Food & Drug Administration for Xpert Xpress CoV-2plus, a rapid molecular diagnostic test for qualitative detection of the virus that causes COVID-19.

Viruses constantly change through mutation and these mutations can give rise to new variants with unique characteristics. Multiple variants of the virus that cause COVID-19 have been documented globally during the pandemic. Cepheid is proactively addressing this increasing genetic diversity by enhancing gene coverage. The new plus version of the test incorporates a 3rd conserved genetic target for SARS-CoV-2 detection to meet the challenge of future viral mutations and optimizes nucleocapsid gene probes to enable consistent virus detection.

Xpert Xpress CoV-2plus joins Xpert^® Xpress CoV-2/Flu/RSV plus and others in Cepheid’s growing portfolio of PCRplus respiratory tests that deliver rapid, accurate, and actionable respiratory results. Xpert Xpress CoV-2/Flu/RSV plus continues to be the most appropriate product for when multiple viruses that cause influenza-like illnesses are circulating. Xpert Xpress CoV2 plusis authorized to be used on any individuals, including for screening those without symptoms or reasons to suspect COVID-19.

Xpert Xpress CoV-2 plus is designed for use on any of Cepheid’s over 40,000 GeneXpert^® systems placed worldwide. The test can provide rapid on-demand detection of SARS-CoV-2 in as soon as 20 minutes for positive results.

Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company. Cepheid is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company’s solutions deliver a better way for institutions of any size to perform sophisticated molecular diagnostic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer.