(RTTNews) - Luminex Corp. (LMNX) announced Wednesday that it has submitted an Emergency Use Authorization or EUA request to the FDA for a new expanded version of its NxTAG Respiratory Pathogen Panel or RPP to include the SARS-CoV-2 virus for high-throughput COVID-19 testing.
According to the company, syndromic testing will streamline respiratory infection diagnosis as COVID-19 pandemic collides with start of flu season.
The new test is a combination of the company's original NxTAG RPP, an FDA-cleared in vitro diagnostic for syndromic respiratory infection testing, and the most relevant circulating pathogen today, SARS-CoV-2.
The company noted that respiratory infections such as COVID-19 and influenza can be challenging to differentiate and diagnose accurately as they feature many of the same symptoms. NxTAG RPP is a multiplex, high-throughput test designed to enable simultaneous detection of the most common respiratory pathogens for a fast, syndromic testing approach.
With the addition of the SARS-CoV-2 virus, the panel now includes 19 viral and 2 bacterial targets.
NxTAG RPP allows clinical labs to run up to 96 samples at a time and generate results in approximately four hours with minimal hands-on time.
The test runs on Luminex's easy-to-use, compact MAGPIX System and is designed for use in high-complexity molecular laboratories.
Nachum "Homi" Shamir, President and CEO of Luminex, 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. "… syndromic respiratory testing will be a critical tool for dealing with the seasonal flu outbreak that is coming on top of a global pandemic."
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