First Light Diagnostics has received the US Food and Drug Administration (FDA) approval for its SensiTox B. anthracis Toxin Test that runs on the company’s MultiPath Analyser.

SensiTox is a qualitative immunofluorescence assay intended for rapid detection of lethal factors in the blood of individuals suspected of anthrax inhalation or exposure to B. anthracis.

The test requires the patient’s blood sample, added directly to a test cartridge, and placed onto the company’s benchtop laboratory instrument MultiPath Analyzer.

It can test up to 20 samples simultaneously, or employ random access, continuous loading of individual samples and provide test results within 20 minutes.

First Light Diagnostics president and CEO Joanne Spadoro said: “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.”

B.anthracis (bacillus anthracis) is a gram-positive and rod-shaped bacterium that causes anthrax and is a biodefence concern due to the high mortality associated with the inhalation of anthrax.

According to First Light, the early diagnosis and treatment of patients are crucial in the course of infection, considering the severity and rapid progression of the disease.

The SensiTox B. anthracis Toxin Test is designed to detect lethal factors, an early biomarker of anthrax infection and support the rapid and early diagnosis of inhalation anthrax.

Its test’s performance has been validated in a US clinical study, evaluating blood specimens presumed to be negative for anthrax and in specimens with the B. anthracis lethal factor.

In the clinical study, the SensiTox B. anthracis Toxin Test showed a 100% Negative (NPA) and 96.2% Positive Percent Agreement (PPA), said the diagnostics company.

First Light has received funding support from the US Department of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA), for the development of the SensiTox B. anthracis Toxin Test and the MultiPath Analyzer.

In addition to the SensiTox B. anthracis Toxin Test, First Light also secured regulatory approval to market its SensiTox C. difficile Toxin Test in the US.