On Mar. 10, 2021, Luminex announced that it had submitted an Emergency Use Authorization application to the U.S. Food and Drug Administration for the company’s new multi-analyte respiratory panel combining Flu A/B and respiratory syncytial virus (RSV) targets with the SARS-CoV-2 target. This submission represents completion of a key milestone in a Luminex funding award from the Biomedical Advanced Research and Development Authority (BARDA), which helped support the rapid development and validation of the assay.

Respiratory infections such as COVID-19 and influenza can be challenging to differentiate and diagnose because they often have overlapping symptoms. Luminex designed the combined assay to quickly deliver clear answers about these infections from a single test and, thereby, help clinical-care teams treat patients more effectively. The ARIES^® Flu A/B & RSV+SARS-CoV-2 Assay can be run on six-unit and 12-unit ARIES^® Systems with minimal hands-on time, producing results in approximately two hours. The ARIES^® System is an FDA-cleared, sample-to-answer, automated molecular diagnostics platform designed for use in moderate and high complexity labs.

Importantly, the ARIES^® Flu A/B & RSV+SARS-CoV-2 Assay is expected to detect new variants of the coronavirus. An in silico analysis of molecular probes used in the assay compared to SARS-CoV-2 sequences available in the GISAID database as of February 11, 2021, determined that key sequences still match and should yield a positive result. The analysis included variants originally detected in the United Kingdom (B.1.1.7), South Africa (B.1.351 or 20H/501Y.V2), Brazil (P.1 lineage or 20J/501Y.V3), and California (one of five reoccurring mutations that constitute the B.1.429 lineage and CAL20C).