Luminex Files EUA for Expanded NxTAG Respiratory Panel Test Including SARS-CoV-2

Luminex has submitted an EUA request to the U.S. Food and Drug Administration (FDA) for a new expanded version of its NxTAG® Respiratory Pathogen Panel (RPP) to include the SARS-CoV-2 virus for high-throughput COVID-19 testing. 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.

Respiratory infections such as COVID-19 and influenza can be challenging to differentiate and diagnose accurately because 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, combining the most common respiratory pathogens in one panel to help facilitate the rapid identification of various individual and co-occurring infectious pathogens.

NxTAG RPP provides scalable throughput, allowing 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.

"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," said Nachum "Homi" Shamir, President and CEO of Luminex. "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."

Since the start of the COVID-19 pandemic, Luminex has focused on expanding capacity for SARS-CoV-2 diagnostic testing across all of its molecular platforms. The company previously launched the NxTAG CoV Extended Panel under an EUA from the FDA and an Authorization for Import or Sale with Conditions from Health Canada, and also received FDA EUA for its ARIES® SARS-CoV-2 Assay. Earlier this month, the company announced it had received FDA EUA for its xMAP® SARS-CoV-2 Multi-Antigen Immunoglobulin G (IgG) Assay, a new serology test that can be run on any of Luminex's xMAP-based high-throughput, gold-standard multiplex platforms. The test detects IgG antibodies, which are an important component of an adaptive immune response and typically reflect sustained immunity to a given pathogen.

The NxTAG CoV Extended Panel and the ARIES® SARS-CoV-2 Assay have each been funded with $642,450 of Federal funds, approximately 36% each of the expected overall cost of development, from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract Nos. 75A50120C00037 (NxTAG CoV Extended Panel) and 75A50120C00043 (ARIES® SARS-CoV-2 Assay). Luminex financed the remaining $1,118,663 of each program, constituting 64% each of the total program costs.