On Mar. 13, 2020, Luminex announced that four independent clinical laboratories had validated laboratory developed tests (LDTs) for automated, rapid detection of the SARS-CoV-2 virus using the sample-to-answer ARIES System. These LDTs demonstrated that high complexity laboratories using the ARIES System were immediately able to add novel coronavirus diagnostics to their testing menu and allowed laboratories to produce results in approximately two hours.

Along with these validation studies, labs across Europe and the United States are in the process of going live with their LDTs using the ARIES^® System, and Luminex intends to submit an EUA for an ARIES^® SARS-CoV-2 Assay next month. The platform uses real-time PCR technology that, when combined with its ability to run LDTs, is ideally suited for facilities that need to develop their own lab-specific testing for which there is no commercially available, FDA-cleared assay. The system provides the flexibility to handle STAT or batch testing and is capable of running different assays simultaneously.

Luminex has also launched and begun shipping its NxTAG^® CoV Extended Panel (RUO), a unique multiplex panel that addresses the coronavirus pandemic using its existing bead-based NxTAG Technology. A number of labs in the Far East, Europe and North America have already validated this panel and are planning to go live with it this week. In addition, Luminex is planning to submit an EUA for this panel to the FDA by the end of this month.