CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
February 2024—Qiagen announced FDA clearance of the NeuMoDx CT/NG assay 2.0 for its NeuMoDx 96 and 288 integrated PCR-based clinical molecular testing systems in the United States. The assay is designed for direct detection of asymptomatic and symptomatic bacterial infections for Chlamydia trachomatis and Neisseria gonorrhoeae. Results are delivered in about an hour.
Qiagen says this clearance supports its test menu expansion for NeuMoDx systems in the U.S. and builds on the 16 EU-certified in vitro diagnostic tests available on these systems, including assays for transplant-associated viruses, respiratory infections, blood-borne viruses, and sexual and reproductive health.
Qiagen, 240-686-7700