FDA Approves Screening Test for Parasitic DiseaseFDA Approves Screening Test for Parasitic Disease

FDA's Center for Biologics Evaluation and Research has approved the first blood test for a parasite that causes Chagas disease, an infection that can be deadly. The Ortho T. cruzi ELISA Test System, made by Johnson & Johnson's Ortho-Clinical Diagnostics (Raritan, NJ), detects antibodies to the Trypanosoma cruzi (T. cruzi) parasite. It is believed to have infected 11 million people worldwide, mostly in Latin America.