Therapy Areas: Infectious Diseases
Luminex files for EUA with FDA for expanded NxTAG Respiratory panel including SARS-CoV-2 to streamline COVID-19 pandemic from normal influenza
23 July 2020 -

Healthcare company Luminex Corporation (NASDAQ:LMNX) said on Wednesday that it has filed an EUA request to the US FDA for a new expanded version of its NxTAG Respiratory Pathogen Panel (RPP) to include the SARS-CoV-2 virus for high-throughput COVID-19 testing.

The company added that the new test is a combination of the original NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing and SARS-CoV-2. NxTAG RPP provides scalable throughput, allowing clinical labs to run up to 96 samples at a time and generate results in approximately four hours with minimal hands-on time.

Including the SARS-CoV-2 virus, the panel now includes 19 viral and two bacterial targets, combining the most common respiratory pathogens in one panel to help facilitate the rapid identification of various individual and co-occurring infectious pathogens.

Additionally, the NxTAG CoV Extended Panel and the ARIES SARS-CoV-2 Assay have each been funded with USD642,450 of Federal funds, about 36% each of the expected overall cost of development from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures, and Luminex financed the remaining USD1.12m of each programme, constituting 64% each of the total programme. costs.

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