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FDA Clearance for FluChip-8G Influenza A+B Assay Identifying Seasonal and Non-Seasonal Flu


InDevR Inc. 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.

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.

 


    

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Date Published: 13th May 2019

Source article link: InDevR, Inc.


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