FDA gives Abbott OK for tropical disease diagnostic
News-Sun staff report November 24, 2011 6:32PM
Updated: January 24, 2012 2:01AM
ABBOTT PARK — Abbott Laboratories has received approval from the FDA for a test which detects Chagas, a tropical disease common to the Americas.
The ABBOTT ESA Chagas is the first Food and Drug Administration-approved supplemental in vitro diagonistic test that detects antibodies to Trypanosoma cruzi, a parasite found only in the Americas and commonly acquired through contact with the blood-sucking triatomine, also known as a “kissing bug.”
Amid concerns about the transmission of Chagas disease through blood, the FDA mandated donor screening in 2007. The American Association of Blood Banks 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, Abbott divisional vice president-diagnostics. “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.”
According to the U.S. Centers for Disease Control and Prevention, as many as 11 million people worldwide are infected with Chagas disease, whichbelongs to a group of neglected tropical diseases that disproportionately affects the world’s poor and rural populations. In the U.S., more than 300,000 are estimated to be infected with Chagas disease.
Chagas disease is endemic throughout much of Mexico, Central America and South America.