Original from: First Light Diagnostic
First Light Diagnostics announced that the US Food and Drug Administration (FDA) has cleared its SensiTox® B. anthracis Toxin Test to be marketed in the U.S.
B. anthracis, the agent that causes anthrax, is a top biodefense concern due to the ease of widespread dissemination and the high mortality and morbidity associated with inhalation anthrax. Because of the severity and rapid progression of the disease, it is critical to diagnose and treat patients early in the course of infection. First Light¡¯s SensiTox B. anthracis Toxin Test detects lethal factor, an early biomarker of anthrax infection, making the test particularly suitable as an aid for the rapid and early diagnosis of inhalation anthrax.
The SensiTox B. anthracis Toxin Test, for use with First Light¡¯s proprietary MultiPath Analyzer, is a sensitive qualitative immunofluorescence assay intended for the rapid detection of lethal factor in blood from individuals with signs and symptoms consistent with inhalation anthrax and a likelihood of exposure to B. anthracis. The test¡¯s performance was evaluated in a clinical study conducted at three sites in the U.S. Negative (NPA) and Positive Percent Agreement (PPA) were evaluated in blood specimens presumed to be negative for anthrax and in contrived blood specimens spiked with the B. anthracis lethal factor, respectively. The clinical study demonstrated 100% NPA and 96.2% PPA.
The 20-minute test has a simple workflow that minimizes specimen handling on the part of the laboratory technician. The patient¡¯s blood sample is added directly to a test cartridge that is placed onto the MultiPath Analyzer, a benchtop laboratory instrument that can test up to 20 samples in parallel or employ random access, continuous loading of individual 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 Chief Executive Officer of First Light Diagnostics.
In addition to the SensiTox B. anthracis Toxin Test, First Light¡¯s SensiTox C. difficile Toxin Test is market cleared in the U.S.
The development of the SensiTox B. anthracis Toxin Test and the MultiPath Analyzer has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201500022C.
