NEW YORK – The US Food and Drug Administration has allowed InBios International to market its point-of-care anthrax test, the firm announced this week.
The Seattle-based firm was granted marketing rights under the FDA's de novo process, InBios said.
The Active Anthrax Detect Plus Rapid Test is intended to diagnose inhalation anthrax and returns results in about 20 minutes. The assay is intended for use by military personnel and medical or healthcare professionals only, the company said in a statement. Inhalation anthrax occurs when someone breathes in anthrax spores and is the deadliest form of the disease, it added.
The immunochromatographic test detects the Bacillus anthracis lethal factor protein and can be used to test serum and venous whole blood from people who have signs of inhalation anthrax and a likelihood of exposure. Although a positive test is presumptively diagnostic for the infection, diagnosis must be based on history, signs, symptoms, exposure likelihood, and additional laboratory evidence, InBios noted. Data showed the test had a negative percent agreement of 100 percent and a positive percent agreement of more than 98 percent, the company said.
"A fast, accurate test is needed to prepare for a potential bioterrorism attack or outbreak," InBios CSO Syamal Raychaudhuri said in a statement. "Our test could play a critical role in thwarting any suspicious activities early on."