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InBios Receives FDA Clearance for Rapid POC Chagas Test

NEW YORK (360Dx) – InBios announced today that it has received 510(k) clearance from the US Food and Drug Administration for an antibody-based point-of-care, rapid test that detects Chagas disease.

The firm's Chagas Detect Plus Rapid Test Kit, developed in collaboration with the Infectious Disease Research Institute in Seattle, employs an immunochromatographic strip assay to detect human IgG antibodies to Trypanosoma cruzi in human serum and whole blood matrices, including venous and capillary whole blood.

InBios President Estela Raychaudhuri said in a statement that the test employs a proprietary multiepitope recombinant antigen target and a proprietary lateral flow system.

Chagas disease is an infection caused by T. cruzi, a protozoan parasite that is transmitted to animals and people by contact with feces or urine from triatomine bugs. Left untreated, it can last a lifetime, but the disease is curable if treatment is initiated soon after infection, InBios said.

In the US, the disease is among a group of parasitic infections targeted by the Centers for Disease Control and Prevention for public health action, and it has been reported in Arkansas, Arizona, Texas, and Tennessee. Around 8 million people in Mexico, Central America, and South America have Chagas disease, and most don't know they are infected, according to the CDC.

InBios said that this is the first point-of-care diagnostic test available in the US for Chagas, and primary care settings now have a highly sensitive and specific, reliable test that gives results in around 20 minutes. In several clinical studies, the test demonstrated greater than 95 percent sensitivity and specificity.

The test already has a CE mark and is available internationally.