FDA OKs First Test to Screen Blood for Chagas Disease
FDA gives the nod to new screening tool for the blood-borne parasite
THURSDAY, Dec. 14 (HealthDay News) -- A new screening test to check donated blood for Chagas disease has been approved by the U.S. Food and Drug Administration. The test, the ORTHO T. cruzi ELISA Test System, detects the Trypanosoma cruzi parasite and is manufactured by Ortho-Clinical Diagnostics, Inc. of Raritan, N.J.
The asymptomatic, parasitic blood-borne disease, usually acquired via insect bites or via blood transfusion, can lead to organ damage in the long term and causes 50,000 deaths a year worldwide. Estimates of the number of people infected place the figure at 11 million people, with the majority of cases in Mexico, Central America and South America.
Testing for the disease is the latest in a constant process of protecting donated blood supplies from newly emerging infectious disease threats, according to Jesse L. Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research.
"Evaluating this test involved a high degree of interaction between FDA scientists, the blood industry and test developers. It is part of an ongoing effort to, wherever possible, identify emerging threats and provide the tools needed to keep blood safe," Goodman said in a statement.