FDA approves Abbott's new Chagas in vitro diagnostic test

Abbott (NYSE: ABT) received approval from the U.S. Food and Drug Administration (FDA) for a new Chagas in vitro diagnostic test. The ABBOTT ESA Chagas is the first FDA-approved supplemental test that detects antibodies to Trypanosoma cruzi (T. cruzi), a parasite found only in the Americas and commonly acquired through contact with the blood-sucking triatomine, also known as a "kissing bug." The test will be used as an additional, more specific test on human serum or plasma specimens found repeatedly reactive using a licensed screening test.

According to the U.S. Centers for Disease Control and Prevention (CDC), as many as 11 million people worldwide are infected with Chagas disease. Chagas disease belongs to a group of neglected tropical diseases (NTD) that disproportionately affects the world's poor and rural populations. In the United States, more than 300,000 individuals are estimated to be infected with Chagas disease.  

Amid concerns about the transmission of Chagas disease through blood, the FDA mandated donor screening in 2007. The American Association of Blood Banks (AABB) Chagas Biovigilance Network reports that nearly 1,500 donors with Chagas disease have been identified in the four years since mandatory donor screening was implemented.

"Chagas disease can cause significant and debilitating symptoms for those infected," said John Coulter, divisional vice president, Diagnostics, Abbott. "The new ABBOTT ESA Chagas test provides organizations that screen blood with an approved testing method to help keep the blood supply safe and enable them to confidently counsel infected donors."