Covid19_LndPg_bnr.Flex.v1 3

 

 

In response to the global outbreak of the novel coronavirus disease (COVID-19), Luminex has developed multiple solutions to enhance our NxTAG® and ARIES® offerings in order to automate and facilitate the detection of coronavirus.

As a high-throughput, more comprehensive option, we have developed the NxTAG® CoV Extended Panel, which can detect SARS-CoV-2, and was authorized by the FDA for Emergency Use Authorization (EUA) on March 27th.

The NxTAG® CoV Extended panel, developed for use on the MAGPIX® System, offers:

  • A highly scalable, cost-effective solution that can process up to 96 samples in approximately 4 hours.
  • Detection of three viral genes to detect SARS-CoV-2 (ORF1ab, E gene, and N gene), enabling sensitive and reliable results.
  • The flexibility to run tests in any combination—use the NxTAG CoV panel as a standalone test to detect
    SARS-CoV-2, detect 20 other common respiratory pathogens with the NxTAG® Respiratory Pathogen Panel (RPP), or run both tests together for a complete picture of a patient’s respiratory health.

SARS-COVID-2 White Paper

Additionally, Luminex has LDT tools that can be used with the latest US CDC or WHO primer sequences to detect SARS-CoV-2, enabling users to develop their own LDTs on the ARIES® sample-to-answer system. Using ARIES® technology, labs have already validated their own ARIES®-based, multi-target tests.

A targeted SARS-CoV-2 testing strategy, using the ARIES® System, offers:

  • Lab-specific testing, including the ability to develop a targeted test for SARS-CoV-2 detection.
  • Customized workflows, allowing users to develop, validate, and automate assays under the recently released EUA path.

 

 


Coronavirus (COVID-19) Press Releases

Luminex Receives FDA Emergency Use Authorization for NxTAG® CoV Extended
Panel to Detect the SARS-CoV-2 Virus that Causes COVID-19 Disease
- March 27th

Luminex Provides Update on SARS-CoV-2 Validation Testing Efforts - March 13th

Luminex Provides Updates on Critical Efforts Related to Novel Coronavirus - March 4th


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This product is for clinical use under the FDA's Emergency Use Authorization. Please contact Luminex at support@luminexcorp.com to obtain the appropriate product information for your country of residence.

This test has not been FDA cleared or approved. This test has been authorized by the FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Luminex received $642K in funding (approximately 36% of the total program cost) through a contract from the Biomedical Advanced Research and Development Authority (BARDA) to develop and validate the NxTAG SARS-CoV-2 Test. This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00037.

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