The US Biomedical Advanced Research and Development Authority (BARDA) has awarded Luminex funding worth $11.3m for developing and validating a respiratory panel, combining flu A/B and respiratory syncytial virus (RSV) targets with the SARS-CoV-2 target that can be run on all ARIES Systems.
The six and 12-cassette systems are automated molecular diagnostic platforms used in moderate and high-complexity labs with various tests that received clearance from the US Food and Drug Administration (FDA).
They can deliver results in under two hours with the minimum hands-on time needed.
Currently, clinical labs, which are challenged by continued Covid-19 testing, are under extra pressure to meet the testing demand linked to seasonal flu and RSV at the same time.
As the symptoms of flu and RSV are similar to Covid-19, it becomes difficult for physicians to differentiate between them.
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A single test that could identify these pathogens simultaneously will help labs to receive more complete test results rapidly without needing additional reagents and other consumables, the company said.
Luminex chairman, president, and CEO Nachum ‘Homi’ Shamir said: “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.
“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.”
The company developed the original ARIES SARS-CoV-2 (EUA) assay with financial aid from BARDA last year.
It noted that the ARIES Flu A/B & RSV+SARS-CoV-2 Assay could identify influenza A/B, RSV, and SARS-CoV-2 simultaneously in a single test, support advanced testing, and reduce supply pressures.
Luminex intends to seek emergency use authorisation (EUA) for the targeted multiplex respiratory panel from the FDA soon and also plans to submit it for 510(k) clearance.
Last March, Luminex received the FDA’s EUA for its NxTAG CoV Extended Panel test intended to detect the SARS-CoV-2 virus that causes Covid-19.