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Influenza A/B assay the first QIAGEN test to receive 510(k)clearance for IVD use on Rotor-Gene Q MDx platform in the U.S., paving the way for further test menu expansion
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.