Diagnostic tests developer InBios International has received the first marketing rights from the US Food and Drug Administration (FDA) for its point-of-care (POC) Active Anthrax Detect Plus Rapid Test.
The Active Anthrax Detect Plus Rapid Test is intended for pulmonary anthrax by supporting the diagnosis of inhalation anthrax.
US-based InBios has developed the test for use by military personnel, and medical and/or healthcare professionals only.
The in vitro immunochromatographic assay can deliver results in approximately 20 minutes, the diagnostic tests developer claimed.
The approval was given via the FDA’s De Novo process for new medical devices or technology.
InBios said that the assay can be used to test serum and venous whole blood from people who have symptoms consistent with inhalation anthrax and a likelihood of exposure.
The test provides visual and rapid qualitative detection of the Bacillus anthracis lethal factor protein, said the company.
A positive result with the Active Anthrax Detect Plus Rapid Test is presumptively diagnostic for B. anthracis infection if the diagnosis is made using the patient’s medical history, signs, symptoms, the likelihood of exposure, and laboratory evidence, the diagnostic firm said.
InBios chief scientific officer Syamal Raychaudhuri said: “With ease of dispersal and a high mortality rate, inhalation anthrax is a great threat to the security and safety of the world.
“A fast, accurate test is needed to prepare for a potential bioterrorism attack or outbreak. Our test could play a critical role in thwarting any suspicious activities early on.”
Clinical performance showed that the Active Anthrax Detect Plus Rapid Test had a negative percent agreement (NPA) of 100% and a positive percent agreement (PPA) of over 98%.
The sensitivity (PPA) of the assay was assessed using artificial positive serum samples, while the specificity study (NPA) was carried out in three POC clinical sites in the US, InBios added.
The De Novo classification for the in vitro immunochromatographic assay got funding support from the US Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and the Biomedical Advanced Research and Development Authority (BARDA).
