Luminex has submitted an application to the US Food and Drug Administration (FDA), seeking emergency use authorisation (EUA) for its new respiratory panel, combining Flu A/B and respiratory syncytial virus (RSV) targets with the SARS-CoV-2 target.

The multi-analyte ARIES Flu A/B & RSV+SARS-CoV-2 Assay can run on all Luminex ARIES Systems.

The latest development indicates the completion of a major milestone in a Luminex funding award from the US Biomedical Advanced Research and Development Authority (BARDA), which helped to quickly develop and validate the assay.

Last month, BARDA awardedĀ Luminex funding worth $11.3mĀ for developing the panel.

As respiratory infections such as Covid-19 and influenza have overlapping symptoms, they are difficult to distinguish and diagnose.

The combined assay can rapidly provide clear results about these infections with a single test and help clinical-care teams to efficiently treat patients.

It can be run on six-unit and 12-unit ARIES Systems with less hands-on time, delivering results in approximately two hours.

Designed for use in moderate and high-complexity labs, the FDA-cleared ARIES System is a sample-to-answer, automated molecular diagnostics platform.

Furthermore, it can potentially identify new coronavirus variants.

Luminex chairman, president, and CEO Nachum ā€˜Homi’ Shamir said: ā€œWe are grateful to BARDA for supporting the development of this important new assay, and are pleased to have fulfilled our commitment to file for EUA so quickly.

ā€œIt is critical to continue expanding the number of FDA-authorised assays that include SARS-CoV-2 detection for a broad range of clinical uses, and we’re proud to have developed a single assay that provides answers about some of the most common respiratory infections, including SARS-CoV-2, in just two hours.ā€

An in-silico analysis of the assay’s molecular probes compared to SARS-CoV-2 sequences available in the GISAID database showed that key sequences still match and should provide a positive result.

The analysis included the UK (B.1.1.7), South African (B.1.351), Brazilian (P.1 lineage), and Californian (B.1.429 lineage and CAL20C) variants.