Luminex seeks FDA authorisation for combined SARS-CoV-2/Flu/RSV panel

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 awarded Luminex funding worth $11.3m 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.

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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 ‘Homi’ Shamir said: “We 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.

“It 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.”

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.