The FDA has granted two 510(k) clearances for Qiagens real-time 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, for in vitro diagnostic use (IVD).'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.'

The Rotor-Gene Q MDx instrument is an automated molecular detection platform based on real-time PCR technology. The system is intended for in vitro diagnostic use with FDA cleared or approved nucleic acid tests in clinical laboratories. 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. These qualities make the Rotor-Gene Q MDx a preferred choice for IVD molecular diagnostic applications.

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 Rotor-Gene Q MDx instrument.

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 U.S. Several other PCR-based assays are either under regulatory review or are being prepared for submission to the FDA - for instance, 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 (CMV).