Luminex notes the funds will support the rapid development and validation of a respiratory panel combining Flu A/B & respiratory syncytial virus (RSV) targets with the SARS-CoV-2 target that can be run on all ARIES® Systems.
These 6- and 12-cassette systems are automated molecular diagnostic platforms used in moderate- and high-complexity labs with a number of FDA cleared tests already available for use on them. The systems produce results in less than two hours with the minimal hands-on time required.
Clinical labs already challenged by continued COVID-19 testing are now under additional pressure to simultaneously meet the testing demand associated with seasonal flu and RSV, whenever these pathogens are in circulation at the same time. These respiratory illnesses can cause symptoms similar to COVID-19, making it difficult for physicians to distinguish between them. A single test that can simultaneously detect these pathogens would allow clinical labs to get more complete answers quickly, while using fewer reagents and other consumables, easing pressure on an already stressed supply chain.
“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,” said Nachum “Homi” Shamir, Chairman, President and CEO of Luminex. “We are grateful to BARDA for its continued support as we seek to streamline respiratory testing with a single assay for the most common pathogens. This 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.”
Luminex developed the original ARIES® SARS-CoV-2 (EUA) Assay with financial support from BARDA* in 2020.
Luminex will submit the targeted multiplex respiratory panel, the ARIES® Flu A/B & RSV+SARS-CoV-2 Assay, to the FDA for Emergency Use Authorization as soon as possible, and eventually plans to submit the panel for 510(k) clearance as well.
Biomedical Advanced Research and Development Authority (BARDA), is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.