Luminex is seeking emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for a new expanded version of the NxTAG respiratory pathogen panel (RPP).

The company has submitted a EUA application to the regulator for expanded NxTAG RPP test to include the SARS-CoV-2 virus for high-throughput Covid-19 testing.

The new test is said to be a combination of Luminex’s original NxTAG RPP and the circulating pathogen SARS-CoV-2.

Luminex’s NxTAG RPP is a multiplex and high-throughput test that will facilitate the simultaneous detection of common respiratory pathogens for the syndromic testing approach.

The panel now includes 19 viral and 2 bacterial targets with the addition of the SARS-CoV-2 virus, enabling to quickly detect various individual and co-occurring infectious pathogens.

The NxTAG RPP test has the capacity to generate results in around four hours

With scalable throughput, the NxTAG RPP test enables clinical labs to run up to 96 samples at a time and generate results in around four hours.

Luminex’s MAGPIX system, which is designed for use in high-complexity molecular laboratories, is suitable to run the NxTAG RPP test.

Luminex president and CEO Nachum “Homi” Shamir said: “Clinical laboratories are straining under the pressure of COVID-19 testing, and the unfortunate reality is that even in these incredibly challenging conditions, labs must now look ahead to the coming flu season.

“We believe that syndromic respiratory testing will be a critical tool for dealing with the seasonal flu outbreak that is coming on top of a global pandemic. We incorporated the SARS-CoV-2 virus into our trusted NxTAG RPP panel to alleviate laboratory capacity constraints and improve the ease of testing.”

Recently, Luminex has secured FDA EUA status for its xMAP SARS-CoV-2 multi-antigen IgG assay.

The company also secured FDA EUA status for its ARIES SARS-CoV-2 assay, which will run on the ARIES system to rapidly detect the virus responsible for Covid-19 disease.