NEW YORK ─ The US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) has awarded Luminex almost $5.4 million for product development on its expanded NxTag Respiratory Pathogen Panel (RPP), the diagnostic firm said on Thursday.
Austin, Texas-based Luminex said the BARDA award is also intended to support a 510(k) filing for clearance of the panel with the US Food and Drug Administration.
The new panel combines the firm's FDA-cleared NxTag RPP syndromic respiratory infection test with a SARS-CoV-2 target, enabling high-throughput COVID-19 testing, the firm said.
With the addition of SARS-CoV-2, the panel includes 19 viral and two bacterial targets, combining the most common respiratory pathogens to help facilitate the rapid identification of individual and co-occurring infectious pathogens. The expanded NxTag RPP will provide scalable throughput, allowing clinical labs to run up to 96 samples at a time and generate results in approximately four hours with minimal hands-on time, Luminex said.
The test, which will run on the firm's Magpix System, is designed for use in high-complexity molecular laboratories.
"The need for rapid, high-quality tests that can simultaneously identify multiple respiratory pathogens has become even more urgent as medical professionals must increasingly differentiate between flu, COVID-19, and other seasonal respiratory illnesses," Nachum Shamir, chairman, president, and CEO of Luminex, said in a statement. "Many of these illnesses have similar or overlapping symptoms, which creates significant challenges for medical professionals, hospitals, patients, and laboratories. The expanded NxTag RPP assay can help address this need."
Luminex noted that it has applied for an FDA Emergency Use Authorization for the expanded test, which would allow clinical labs to use it prior to a 510(k) clearance.
On Wednesday, the company announced that it had received a $683,500 award from BARDA to support the enhancement of its xMap SARS-CoV-2 Multi-Antigen IgG Assay.