First Light Diagnostics Bags US FDA Nod For Anthracis Toxin Test

First Light Diagnostics announced that the FDA has approved the SensiTox B. anthracis Toxin Test for sale in the United States. Because of the ease with which B. anthracis spreads and the severe mortality and morbidity associated with inhalation anthrax, B. anthracis is a major biodefense issue. Also the disease's severity and quick progression, it is vital to diagnose and treat patients as soon as possible after 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, as per pharmabiz. 

The SensiTox B. anthracis Toxin Test, designed for use with First Light's proprietary MultiPath Analyzer, is a sensitive qualitative immunofluorescence assay for the rapid detection of lethal factor in blood from individuals with signs and symptoms consistent with inhalation anthrax and a likelihood of B. anthracis exposure.   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, in a clinical study conducted at three sites in the US. The clinical trial found 100% NPA and 96.2% PPA.

The 20-minute test offers a straightforward process that minimizes specimen handling by the laboratory worker.  The patient's blood sample is immediately injected into a test cartridge, which is then inserted into the MultiPath Analyzer, a benchtop laboratory apparatus that can analyze up to 20 samples in tandem or use random access, continuous loading of individual samples.