NEW YORK (GenomeWeb News) – Qiagen today announced its real-time PCR instrument Rotor-Gene Q MDx and the artus Infl A/B RG RT-PCR kit for Influenza A/B has received 510(k) clearance from the US Food and Drug Administration.
The Rotor-Gene Q MDx instrument is an automated molecular detection platform that is intended for in vitro diagnostic use with FDA-cleared or approved nucleic acid tests in clinical laboratories. Using a centrifugal rotary design for the amplification and quantification of DNA molecules, Rotor-Gene Q MDx enables "near-perfect well-to-well thermal and optical uniformity and a fast data acquisition rate," Qiagen said.
The artus Influ A/B RG RT-PCR kit is a real-time PCR IVD test for the differential diagnosis of Influenza A and B viral infections through qualitative detection and identification. The test uses nasopharyngeal swab samples and runs on the Rotor-Gene Q MDx instrument.
Peer Schatz, CEO of Qiagen, called the FDA clearances an important milestone for the company. "The various Rotor-Gene Q models marketed by Qiagen are not only an integral part of our revolutionary lab automation platform QIAsymphony RGQ, but are also among the most widely used stand-alone molecular detection platforms worldwide," he said. "The FDA clearances now pave the way to make this market-leading assay portfolio available to clinical laboratories in the US as well."
Qiagen added that the artus Infl A/B RG RT-PCR kit is the first of a number of IVD molecular diagnostics it plans to launch on the Rotor-Gene Q MDx instrument in the US, and other PCR-based assays are either being reviewed by FDA or are being prepared for submission to the agency. Among the assays it noted are a companion diagnostic based on KRAS mutations for guiding treatments for colorectal cancer; a companion diagnostic based on EGFR mutations to guide lung cancer treatment; and an assay for the detection of cytomegalovirus.
Various versions of the Rotor-Gene Q real-time PCR cyclers are registered as medical devices in many markets outside the US, including the European Union, China, Japan, Korea, Brazil, Australia, and Russia, Qiagen said.