CE marking for a 13-pathogen test
Cepheid, a Danaher company, said it had received CE marking under the in vitro diagnostic medical device regulation for the Xpert Respiratory Panel, a multiplex PCR test that detects 13 common viral and bacterial respiratory pathogens from one nasopharyngeal swab sample. The test is intended to help diagnose suspected infectious respiratory tract infections, alongside other clinical and pathological factors, the company said.
Run on existing GeneXpert systems
The panel runs on GeneXpert systems already in use, and Cepheid said it needs under a minute of hands-on work while giving answers on demand. The company said the test joins a respiratory portfolio that includes low- and mid-plex options, so providers can select a test for each patient.
Shipping in the coming weeks
Cepheid said the panel will begin shipping to countries that accept the CE mark in the coming weeks.
What the company says it is for
Christoph Martinaud, senior director of medical affairs for EMEA at Cepheid, said that as healthcare systems across Europe prepare for the respiratory season, matching the right test to the right patient matters more than ever. Cepheid said that identifying multiple viral and bacterial infections can help inform treatment decisions and support appropriate use of antibiotics.
