FDA clears Rotor-Gene Q MDx Instrument and compatible Influenza A/B assay (Qiagen)

The FDA has approved the Rotor-Gene Q MDx instrument and the artus Infl A/B RG real-time PCR IVD test, from Qiagen, for use in detection and identification of Influenza A and B viral infections in nasopharyngeal swab samples. The Rotor-Gene Q MDx instrument is an automated molecular detection platform based on real-time PCR technology. The artus Infl A/B RG RT-PCR Kit is the first in a series of IVD molecular diagnostics that Qiagen plans to launch on the Rotor-Gene Q MDx platform in the US. Several other PCR-based assays are either under regulatory review or are being prepared for submission to the FDA including proposed companion diagnostics based on mutations in the KRAS gene to guide Colorectal Cancer treatments and on mutations in the EGFR gene to guide Lung Cancer treatments, as well as an assay for detection of cytomegalovirus.