Firm will seek approval of a range of diagnostic assays for the platform.
Qiagen confirmed the receipt or FDA 510(k) clearance for both its Rotor-Gene Q MDx real-time PCR platform, and also the artus Infl A/B RG RT-PCR Kit, which discriminates between influenza A and B. The diagnostic assay is the first to be cleared for use on the Rotor-Gene Q MDx instrument in the U.S.
The in vitro diagnostic Rotor-Gene Q MDx platform is an automated instrument designed for use by clinical laboratories with FDA-approved nucleic acid tests. The system features a centrifugal rotary design to amplify and quantify DNA, which Qiagen claims provides exemplary well-to-well thermal and optical uniformity, combined with fast data acquisition.
The newly approved artus Infl A/B RG RT-PCR Kit is used to aid in the differential diagnosis of influenza A and B infections using nasopharyngeal swab samples. The IVD assay is the first in a number of IVD molecular diagnostics Qiagen says it aims to launch on the Rotor-Gene Q MDx platform in the U.S., including KRAS gene and EGFR gene companion diagnostics for cancer therapy, and a cytomegalovirus diagnostic assay. A number of assays are already either under regulatory review or in preparation for FDA submission.
Qiagen currently markets different Rotor Gene Q RT-PCR cycler models in various non-U.S. markets, including the EU, Japan, and China. The different models are marketed either as standalone IVD instruments, or as part of the modular QIAsymphony RGQ IVD platform, which automates the entire workflow from sample processing to generation of results.