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InDevR Gets FDA 510(k) Clearance for Influenza Assay

NEW YORK (GenomeWeb) — InDevR said today that it has received 510(k) clearance from the US Food and Drug Administration for its FluChip-8G Influenza A+B assay.

The RT-PCR-based in vitro diagnostic is designed to detect whole gene segments for influenza A and B viruses in order to identify and differentiate them. A machine learning algorithm then identifies the signal pattern of specific target virus groups to help characterize infections as seasonal or nonseasonal.

"This successful clearance follows several years of assay development with the goal of improving the nation's preparedness to respond to an influenza pandemic," InDevR Chief Technology Officer Erica Dawson said in a statement. "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."

In 2014, Boulder, Colorado-based InDevR signed a $14.7 million contract with the Biomedical Advanced Research and Development Authority for the development of FluChip-8G.