Luminex’s assay receives FDA EUA for use in SARS-CoV-2 testing

5 March 2021 (Last Updated March 5th, 2021 10:32)

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for a new expanded version of Luminex’s NxTAG Respiratory Pathogen Panel (RPP) that includes the SARS-CoV-2 virus for high-throughput respiratory testing.

Luminex’s assay receives FDA EUA for use in SARS-CoV-2 testing
With the addition of the SARS-CoV-2 virus target, the panel has a total of 19 viral and two bacterial targets. Credit: Fernando Zhiminaicela / Pixabay.

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for a new expanded version of Luminex’s NxTAG Respiratory Pathogen Panel (RPP) that includes the SARS-CoV-2 virus for high-throughput respiratory testing.

The new assay provides labs with high-throughput, syndromic respiratory testing capabilities.

The test is a combination of the company’s NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing and SARS-CoV-2.

Respiratory infections such as Covid-19 and influenza are difficult to distinguish and diagnose as they usually have similar symptoms.

A multiplex, high-throughput test, NxTAG RPP helps to identify common respiratory pathogens and provide a quick, syndromic testing approach.

With the addition of the SARS-CoV-2 virus target, the panel has a total of 19 viral and two bacterial targets. It combines common respiratory pathogens in a panel to support the quick detection of different individual and co-occurring infectious pathogens.

The test also offers scalable throughput, helping clinical labs to run up to 96 samples at a time and deliver results in approximately four hours with minimal hands-on time.

Designed for use in high-complexity molecular laboratories, the assay runs on Luminex’s easy-to-use, compact MAGPIX System.

Luminex noted that the NxTAG RPP + SARS-CoV-2 Assay could identify newly emergent coronavirus variants.

Luminex chairman, president, and CEO Nachum Shamir said: “Given the emergence of new respiratory pathogens and new variants of these pathogens, it will be increasingly challenging to identify and distinguish the presence and co-existence of SARS-CoV-2, influenza, and other common respiratory pathogens.

“As a highly accurate, low-cost, multiplex test, our NxTAG RPP + SARS-CoV-2 test delivers an ideal solution for this challenge.”

A version of the assay, which detects Legionella pneumophila and the 2009 H1N1 Flu A subtype, also received a CE Mark and was commercialised in Europe last month.

In March last year, Luminex received the FDA EUA for its NxTAG CoV Extended Panel test intended to detect the SARS-CoV-2 virus.