FDA grants 510(k) clearance for QIAGEN’s molecular detection PCR technology

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced that the U.S. Food and Drug Administration (FDA) has granted two 510(k) clearances for its real-time PCR (polymerase chain reaction) 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 MDxa 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. Influenza is one of the most frequent respiratory diseases. Since many flu-like symptoms may be caused by other pathogens, testing for influenza viruses helps to reduce the inappropriate use of antibiotics and to determine whether antiviral therapy would be appropriate. According to the Centers for Disease Control and Prevention, about 250,000 influenza tests are performed in U.S. laboratories during the annual flu season. Former versions of the artus Infl A/B RG RT-PCR kit were among the most widely used assays in the influenza epidemics 2005/2006 and 2009/2010 worldwide.

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).

Outside the U.S., the various models of Rotor-Gene Q high-performance real-time PCR cyclers already gained registrations as medical device 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.