NEW YORK ─ Luminex on Friday announced that it has received $11.3 million in funding from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to support the development and validation of a multiplex respiratory panel for flu A/B, respiratory syncytial virus (RSV), and SARS-CoV-2 targets on its Aries systems.
BARDA announced separately that the Luminex TaqMan-based panel will maximize benefits from two of its current assays ─ Aries SARS-CoV-2 and Aries Flu A/B & RSV ─ and offer independent results for the four targets.
Austin, Texas-based Luminex noted that it anticipates submitting an EUA application to the US Food and Drug Administration for the Aries multiplex respiratory panel as soon as possible and applying for FDA 510(k) clearance eventually.
"We believe that this targeted multiplex assay will play a pivotal role in helping healthcare professionals efficiently and effectively manage individuals with respiratory illness symptoms for years to come," Nachum Shamir, chairman, president, and CEO of Luminex, said in a statement.
A single assay for the most common pathogens "will allow laboratories, most of which are already operating in resource-constrained environments, to run one test instead of two or more without sacrificing clinical results," Shamir added.
Luminex said its Aries automated six- and 12-cassette MDx systems produce test results in less than two hours and require minimal hands-on time. Moderate- and high-complexity labs use the automated systems to run the firm's FDA-cleared tests.
The company has SARS-CoV-2 assays on a few different test systems.
Luminex noted that with financial support from BARDA in 2020 it developed a standalone Aries SARS-CoV-2 assay which received FDA Emergency Use Authorization. Last September, the company announced that BARDA had awarded almost $5.4 million for product development on its expanded NxTag Respiratory Pathogen Panel.
FDA recently said it is deprioritizing a Luminex application to obtain EUA for a standalone SARS-CoV-2 assay on the company's Verigene I system, but Luminex announced is moving ahead with EUA applications.