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.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
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.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataThe 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.
