FDA Clearances for Qiagen Rotor-Gene Q MDx Instrument and Influenza A/B Assay
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).
Tags: Influenza, Swabs, Automation, PCR, Cytomegalovirus, FDA
Date Published: April 17, 2012
Source article link: QIAGEN Benelux B.V. » company contact details
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