First Light Diagnostics Receives Additional Funding from the Biomedical Advanced Research and Development Authority (BARDA)

Funding Supports Continued Development of the SensiTox™ B. anthracis Toxin Test

First Light Diagnostics, Inc., a developer of breakthrough automated products for the rapid diagnosis and treatment of life-threatening infections, today announced the authorization of a $4 million award from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. These funds will continue BARDA’s support of First Light Diagnostics’ proprietary MultiPath™ platform and a rapid ultrasensitive test to identify victims of an anthrax attack. The test’s unique combination of high performance, high-throughput, and ease-of-use underlies its value for accommodating the surge in testing in a public health emergency. Using the company’s powerful single-molecule counting MultiPath technology, the test detects Lethal Toxin, an early blood marker of anthrax which is made by the pathogen Bacillus anthracis, directly in whole blood without requiring any sample preparation by the user.

“BARDA has been a valuable partner to First Light as we develop the MultiPath platform and test menu,” said David Macdonald, President and Chief Executive Officer of First Light Diagnostics. “We are excited to continue our work with BARDA as we prepare to commercialize our groundbreaking rapid diagnostic tests and automated platform.”

The additional funding will be used to complete the final stages of product development, including a multi-site clinical study to support the U.S. Food and Drug Administration (FDA) submission of the SensiTox B. anthracis Toxin Test. The new award brings the cumulative value of the BARDA contract to $39.7 million.

Using a primary blood specimen, the SensiTox B. anthracis Toxin Test, run on the MultiPath Analyzer, reports a test result in less than 30 minutes. In a biothreat and public health emergency, the assay can be an effective means to rapidly test large numbers of people suspected of exposure to anthrax. 

“Today’s national experience with COVID-19 highlights the need for accurate, rapid, and high-volume testing in public health emergencies,” said Dr. Don Straus, Founder and Chief Scientific Officer of First Light Diagnostics. “BARDA’s investment in our tests and platform will help address this critical need.”

The automated MultiPath platform funded by the BARDA contract supports the broad test menu being developed by First Light Diagnostics. Although First Light Diagnostics MultiPath Analyzer is not available yet for commercial use, the company’s first test, the SensiTox C. difficile Toxin Test, along with the MultiPath Analyzer, are currently under review at FDA. Additionally, First Light Diagnostics is developing a menu of tests for pathogen identification and antimicrobial susceptibility testing (AST) to determine effective therapy for important infections. BARDA has previously funded the company’s rapid AST test for urinary tract infections, which will deliver results in hours rather than the days required by today’s tests.

Acknowledgment

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500022C.

About First Light Diagnostics, Inc.

First Light Diagnostics is developing and commercializing a uniquely broad range of breakthrough diagnostic products to rapidly, sensitively, and cost-effectively detect life-threatening infections, determine effective antibiotics at the onset of infection, and attenuate the spread of antibiotic resistance. Based on its proprietary MultiPath detection technology, First Light’s products combine the clinical performance of the most advanced commercial laboratory tests with speed, cost-effectiveness, and ease-of-use. This will improve patient outcomes, reduce healthcare costs, and prevent inappropriate use of powerful antibiotics. Don Straus is the company’s Founder and primary inventor of the company’s core scientific technology. To learn more, please visit: www.firstlightdx.com.

David Macdonald
President and CEO
First Light Diagnostics
dmacdonald@firstlightdx.com
Mobile: (858) 997-9641

Source: First Light Diagnostics