FDA Clearance for QIAGEN’s Rotor-Gene Q MDx Instrument and Influenza A/B Assay

QIAGEN has announced that the U.S. Food and Drug Administration (FDA) has granted two 510(k) clearances for its real-time polymerase chain reaction (PCR) instrument Rotor-Gene Q MDx and a compatible test for the detection of Influenza A/B, the artus Infl A/B RG RT-PCR Kit.

The Rotor-Gene Q MDx instrument is an automated molecular detection platform based on real-time PCR technology and is intended for in vitro diagnostic use with FDA cleared or approved nucleic acid tests. The platform uses a unique centrifugal rotary design to amplify and quantify DNA molecules, enabling a near-perfect well-to-well thermal and optical uniformity and a fast data acquisition rate.

The artus Infl A/B RG RT-PCR Kit is a multiplex real-time PCR IVD test intended to aid in differential diagnosis through qualitative detection and identification of Influenza A and B viral infections in nasopharyngeal swab samples using the Roto-Gene Q MDx instrument. The 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 U.S.

"The FDA clearances for the Rotor-Gene Q MDx along with the first assay for use on this system represent an important milestone for QIAGEN," said Peer M. Schatz, Chief Executive Officer of QIAGEN N.V. "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. Outside the U.S., our customers already have access to a broad portfolio of molecular diagnostic tests for use on these platforms. The FDA clearances now pave the way to make this market-leading assay portfolio available to clinical laboratories in the U.S. as well."

Outside the U.S., the various models of Rotor-Gene Q high-performance real-time PCR cyclers have already gained registrations as medical devices in many key markets including the European Union, China, Japan, Korea, Brazil, Australia and Russia. Subject to regulatory approvals in different regions and countries of the world, QIAGEN markets various Rotor-Gene Q models as a standalone IVD instrument or as part of the modular IVD platform QIAsymphony RGQ, which automates entire laboratory workflows from initial sample processing to the final result.