FDA clears new diagnostic panels from QIAGEN and Cepheid

The U.S. Food and Drug Administration has granted clearances to two new molecular diagnostic tests aimed at improving pathogen identification.

QIAGEN N.V. received clearance for its second QIAstat-Dx bloodstream infection panel. This new assay targets gram-negative bacteria and includes 13 bacterial targets and 18 antimicrobial resistance markers. Following a previous clearance in August for gram-positive bacteria and fungi, this addition completes QIAGEN’s U.S. bloodstream infection portfolio. The test is designed to identify pathogens and resistance markers approximately one hour after a blood culture turns positive.

Separately, the FDA cleared Cepheid’s Xpert Respiratory Panel. This multiplex PCR test detects 13 common viral and bacterial respiratory pathogens from a single nasopharyngeal swab. Designed to assist in diagnosing respiratory tract infections, the panel aims to help clinicians make informed decisions and support responsible antibiotic use. Cepheid, a Danaher company, expects to begin shipping the panel to U.S. customers in the coming weeks.