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:
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:
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This product is for clinical use under the FDA's Emergency Use Authorization. Please contact Luminex at firstname.lastname@example.org 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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