The company is planning to submit an application to secure EUA for the multiplex assay
Luminex has secured $11.3m in funding from the Biomedical Advanced Research and Development Authority (BARDA) to support the development and validation of test combining SARS-CoV-2 and Flu/RSV respiratory panel.
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services.
The company will use the funds to 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, which can be run on all ARIES systems.
Luminex is planning to submit an application to secure an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the ARIES Flu A/B & RSV+SARS-CoV-2 Assay. It is also planning to submit the panel for 510(k) clearance.
ARIES, which is available as a six-cassette system and 12-cassette system, is an automated molecular diagnostic platform suitable for moderate and high-complexity labs.
The system has the potential to generate results with two hours with the minimal hands-on time required.
Last year, the company developed ARIES SARS-CoV-2 (EUA) Assay with financial assistance from BARDA.
Luminex chairman, president and CEO Nachum Homi Shamir said: “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 EUA status enables clinical laboratories to use the serology assay to detect the presence of antibodies in people who have been infected with the virus that results in Covid-19.