NEW YORK ─ The US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) has awarded an additional $4 million to First Light Diagnostics to support continued development of the firm's MultiPath platform along with a rapid test to identify victims of an anthrax attack, the Chelmsford, Massachusetts-based diagnostics company said on Tuesday.
First Light said it will use the additional funding to complete the final stages of product development, including a multisite clinical study to support a US Food and Drug Administration submission for the SensiTox B. anthracis Toxin Test.
Using single-molecule counting MultiPath technology, the test detects lethal toxin directly in whole blood without requiring sample preparation, First Light said.
Lethal toxin is an early blood marker of anthrax made by the pathogen Bacillus anthracis.
The test would provide high performance, high-throughput, and ease-of-use to accommodate a surge in testing during a public health emergency, the company said.
Using a primary blood specimen, the SensiTox B. anthracis Toxin Test, running on the MultiPath Analyzer, reports a result in less than 30 minutes, providing an effective means to rapidly test large numbers of people suspected of exposure to anthrax, First Light added.
The new award brings the cumulative value of the BARDA contract to $39.7 million. In 2019, the company had announced that it received an additional $4.3 million in new funding to develop MultiPath.
First Light noted that its SensiTox C. difficile Toxin Test and MultiPath Analyzer are currently under review by the FDA. Further, the company is developing a menu of tests for pathogen identification and antimicrobial susceptibility testing to determine effective therapy for infections.