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 for high-complexity labs, we have developed the NxTAG® CoV Extended Panel, which can detect SARS-CoV-2, and have received Emergency Use Authorization (EUA) from the US FDA and Medical Device Authorization for Importation or Sale for Health Canada.
The NxTAG® CoV Extended Panel was developed for use on the MAGPIX® System, and offers:
For more targeted coronavirus testing in moderate-complexity labs, the ARIES® SARS-CoV-2 Assay is a sample-to-answer test that detects SARS-CoV-2 in nasopharyngeal swabs, and now has received an EUA from the FDA.
The ARIES® SARS-CoV-2 Assay offers:
Additionally, Luminex has LDT tools1 that can be used with the latest US CDC and WHO primer sequences to detect SARS-CoV-2, enabling users to develop their own LDTs on the ARIES® sample-to-answer system. Using this approach, labs have already validated their own ARIES®-based, multi-target tests.
A targeted SARS-CoV-2 LDT testing strategy using the ARIES® System offers:
Serology assay development utilizing Luminex's xMAP multiplexing technology for COVID-19, click here.
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The NxTAG® CoV Extended Panel and the ARIES® SARS-CoV-2 Assay are for clinical use under the FDA's Emergency Use Authorization. Please contact Luminex at email@example.com to obtain the appropriate product information for your country of residence.
The NxTAG® CoV Extended Panel and the ARIES® SARS-CoV-2 Assay have not been FDA cleared or approved. They have 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. These tests are 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.
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.
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