510(k) market clearance for FluChip-8G Influenza A+B Assay
InDevR receives 510(k) market clearance for the first influenza diagnostic assay capable of distinguishing between seasonal and non-seasonal influenza A subtypes
BOULDER COLORADO (4/30/19) — InDevR Inc., a leader in progressive analytical technologies, announced today that they have received 510(k) market clearance for their FluChip-8G Influenza A+B Assay from the United States Food and Drug Administration (FDA).
FluChip-8G is the first cleared influenza diagnostic capable of positively characterizing a wide variety of viruses as “non-seasonal” and characterizing seasonal viruses in a single multiplexed assay with same-day results.
According to Dr. Nancy Cox, retired former director of the Influenza Division within the Centers for Disease Control and Prevention,
“This is a tremendous accomplishment by the extraordinary team of scientists and engineers at InDevR. 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 in vitro diagnostic assay was developed for the qualitative detection and differentiation of seasonal and non-seasonal influenza A viruses as well as the genetic lineage of influenza B viruses. Importantly, the assay is capable of detecting a wide variety of non-seasonal influenza A viruses and positively identifying them as “non-seasonal”, including subtypes with recognized pandemic potential such as H7N9 and H5N1. The open platform molecular diagnostic system consists of a low-density microarray and reagent kit, microarray imaging system, and custom software. The assay is based on multiplexed RT-PCR amplification of whole influenza gene segments in combination with detection on a microarray and subsequent AI-based pattern-recognition for automated interpretation.
Dr. Erica Dawson, InDevR’s Chief Technology Officer said:
“We are excited about InDevR’s first 510(k) market clearance for the FluChip-8G Influenza A+B Assay. 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.”
Early development of the FluChip-8G technology was supported by a Small Business Innovation Research Grant R43/44 AI077112 through the National Institutes for Allergy and Infectious Disease (NIAID); National Institutes of Health (NIH). Advanced development of the FluChip-8G platform has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201400010C and HHSO100201500024C.
The content of this news release is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or BARDA.
InDevR is a global leader in progressive new analytical technologies that enable accelerated development and manufacturing of vaccines and other biotherapeutics. Other InDevR products include the VaxArray portfolio of game-changing multiplexed potency assays for vaccines and the Cypher One system for digital imaging and automated interpretation of hemagglutination assays. For more information about the company and products, please visit http://www.