Analytical technologies company InDevR Inc reported on Tuesday the receipt of United States Food and Drug Administration (FDA) 510(k) market clearance for its FluChip-8G Influenza A+B Assay that is capable of distinguishing between seasonal and non-seasonal influenza A subtypes.

According to the company, the FluChip-8G is the first cleared influenza diagnostic capable of positively characterising a wide variety of viruses as "non-seasonal" and characterising seasonal viruses in a single multiplexed assay with same-day results.

The company said the in vitro diagnostic assay is capable of detecting a wide variety of non-seasonal influenza A viruses and positively identifying them as 'non-seasonal', including subtypes with recognised pandemic potential such as H7N9 and H5N1.

In conjunction, the company's 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.

InDevRd added that the early development of the company's FluChip-8G technology was supported by a Small Business Innovation Research Grant through the National Institutes for Allergy and Infectious Disease, National Institutes of Health. Advanced development 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.