FDA has granted premarket notification (510(k)) clearance for the FluChip-8G influenza A and B assay from InDevR, Boulder, Colo, as the first influenza diagnostic capable of distinguishing between seasonal and nonseasonal subtypes of influenza A, with same-day results.
“This is a tremendous accomplishment by the extraordinary team of scientists and engineers at InDevR,” says Nancy Cox, PhD, retired former director of the influenza division at the US Centers for Disease Control and Prevention. “I applaud their efforts to develop an in vitro diagnostic that can be used as an early warning system for the emergence of new strains of influenza.”
The multiplexed assay was developed for the qualitative detection and differentiation of seasonal and nonseasonal influenza A viruses as well as the genetic lineage of influenza B viruses. Importantly, the assay is capable of detecting and positively identifying a wide variety of influenza A viruses as ‘nonseasonal,’ including subtypes such as H7N9 and H5N1, which are recognized as having pandemic potential.
The open-platform molecular diagnostic consists of a low-density microarray and reagent kit, microarray imaging system, and custom software. Performance of the assay involves multiplexed amplification of whole influenza gene segments by reverse transcriptase polymerase chain reaction, detection via microarray imaging, and subsequent artificial intelligence-based pattern recognition for automated interpretation.
“We are excited about InDevR’s first 510(k) market clearance for the FluChip-8G influenza A and B assay,” says Erica Dawson, PhD, chief technology officer at InDevR. “This successful clearance follows several years of assay development with the goal of improving the nation’s preparedness to respond to an influenza pandemic. We hope that placement of this FluChip-8G technology in the field will bring us another step closer to ensuring timely detection of emerging influenza threats.”
For further information, visit InDevR.