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First Light Diagnostics Gets FDA Clearance for Anthrax Toxin Test

NEW YORK – First Light Diagnostics announced on Tuesday that it has received clearance from the US Food and Drug Administration for an assay to detect B. anthracis, the infectious agent that causes anthrax toxicity when inhaled.

The assay, called SensiTox B. anthracis Toxin Test, takes 20 minutes to run directly from blood samples using First Lights' MultiPath benchtop immunofluorescence analyzer system. The analyzer can run 20 samples in parallel or in a random access mode with continuous loading. It was cleared along with a Clostridioides difficile assay in 2021.

Anthrax is a biodefense concern because it can cause high mortality and morbidity when inhaled, First Light noted in a statement. The firm's test detects an early biomarker of infection making it suitable for rapid, early diagnosis, it said.

The development of the SensiTox assay was supported in part by a contract worth approximately $40 million from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA).

First Light said the test’s performance was evaluated in a clinical study conducted at three US sites, and negative and positive percent agreement were 100 percent and 92.6 percent, respectively, in contrived Bacillus anthracis blood samples.

“We are very pleased with the results of the clinical study and the overall performance of our test. We are confident that our test, with its demonstrated performance, and rapid time to result would have enormous public health benefit in a biothreat situation,” said Joanne Spadoro, president and CEO of First Light Diagnostics.