On Mar. 4, 2020, Luminex announced they were working on multiple solutions to augment their NxTAG and ARIES offerings in order to facilitate and automate the detection of SARS-CoV-2.

Luminex has developed a unique multiplex panel that addresses the current coronavirus outbreak using its existing bead-based NxTAG Technology. This expanded panel has undergone initial testing using samples at Chinese Center for Disease Control and Prevention (China CDC) locations.

Early results seem very promising and the company expects to conclude this testing in the next several days. In addition, Luminex has begun validation in the United States at a number of existing customer facilities. This panel should be available to ship to customers in a few weeks, under the terms of the EUA listed above. 

This expanded panel includes three gene targets for SARS-CoV-2 (ORF, E-gene, and N-gene), as well as SARS-CoV and MERS-CoV, and will be the first assay panel globally that will be able to simultaneously test for each of these coronavirus strains. Luminex’s NxTAG^® Respiratory Pathogen Panel (RPP), which was cleared by the FDA and other worldwide agencies more than four years ago, can be run in parallel with the expanded outbreak panel to identify and/or rule out both existing and novel respiratory infections.

The existing RPP test and this new expanded panel are both plate-based, high-throughput, low-cost solutions that run on the MAGPIX^® instrument. This combination of assays offers labs an ideal solution for their anticipated high-volume testing of respiratory infections, including both flu and other coronaviruses.

In addition, Luminex has evaluated a single-target test on the ARIES^® System for SARS-CoV-2. The company has had two European reference labs successfully validate a multi-targeted test using the ARIES^® System and are also currently validating the test with customers in the United States. ARIES^® uses real-time PCR technology that, when combined with its ability to run laboratory developed tests (LDTs), is ideally suited for situations such as the current pandemic.

This SARS-CoV-2 target incorporates the latest U.S. Centers for Disease Control and Prevention (CDC) primer sequences and is currently available to customers who use the ARIES^® System. This testing can be validated by qualifying laboratories under the aforementioned EUA path. The ARIES^® System currently has seven FDA cleared assays, including Flu A/B & RSV.