Policy & Regulation
Luminex receives USD5.39m from BARDA to support FDA 510(k) Filing for NxTAG RPP including SARS-CoV-2 and most up-to-date respiratory pathogen targets
25 September 2020 -

Healthcare company Luminex Corporation (NASDAQ:LMNX) reported on Thursday the receipt of USD5.39m to conduct product development work and complete a 510(k) filing for its expanded NxTAG Respiratory Pathogen Panel (RPP), including the SARS-CoV-2 virus for high-throughput COVID-19 testing and differentiate COVID-19 from current strains of other common respiratory illnesses, including flu.

The company received the USD5.39m funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services.

According to the company, the expanded NxTAG RPP combines the original NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing, with the most relevant circulating pathogen, SARS-CoV-2. It has submitted an Emergency Use Authorization (EUA) to the US FDA for the expanded test, which would allow clinical labs to use the panel prior to 510(k) clearance.

Following the addition of SARS-CoV-2, the expanded NxTAG RPP will provide scalable throughput, allowing clinical labs to run up to 96 samples at a time – generating results in approximately four hours with minimal hands-on time. The test will be run on the company's easy-to-use, compact MAGPIX System and is designed for use in high-complexity molecular laboratories.

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