Cepheid Gains CE Marking for Xpert® Respiratory Panel

Sunnyvale-based Cepheid has secured CE marking under the in vitro medical device regulation (IVDR) for its Xpert Respiratory Panel. This multiplex PCR test identifies 13 viral and bacterial respiratory pathogens from a single sample. It aids in diagnosing respiratory tract infections, crucial for patients with non-specific symptoms like fever and cough.

The test targets influenza-like illnesses, which annually cause up to 50 million symptomatic cases in Europe. These infections pose significant health challenges, particularly to vulnerable groups who may face severe outcomes.

The Xpert Respiratory Panel, compatible with Cepheid's GeneXpert systems, supports healthcare providers by offering diagnostic flexibility. It reduces time to results and enhances clinical management, crucial as Europe prepares for the respiratory season.

With less than a minute of hands-on time, the test will soon be available in CE-mark-accepting countries.