NEW YORK – First Light Diagnostics announced on Tuesday that its SensiTox C. difficile Toxin Test and its MultiPath Analyzer have received marketing clearance from the US Food and Drug Administration.
The test detects Clostridiodes difficile toxins A and B via single molecule counting, which enables ultrasensitive detection of toxins and biomarkers at lower levels than other rapid tests on the market, the company said in a statement. It returns results in 35 minutes on the fully automated high throughput MultiPath Analyzer.
In a clinical study, the test "was shown to have excellent clinical sensitivity and specificity," the company added. First Light CEO Joanne Spadoro said in a statement that the company is "convinced our test has enormous clinical value in the diagnosis and rapid treatment of C. difficile infection."
The Chelmsford, Massachusetts-based firm is also developing products for the rapid generation of antimicrobial susceptibility test results, including a UTI-Direct test for urinary tract infections that detects the infections, identifies pathogens, and determines optimal antibiotic treatment.