FDA Clears Techlab Test for Intestinal Parasite

FDA has cleared a Techlab 510(k) for its E. Histolytica Quik Chek, a rapid diagnostic test for detecting pathogenic E. histolytica that does not cross react with non-pathogenic Entamoeba dispar. The test targets an adhesin protein unique to E. histolytica, an intestinal parasite which infects an estimated 50 million people each year and is characterized by bloody diarrhea, colitis, and liver abscesses, according to the company. The disease is fatal in up to 100,000 cases annually, and has been diagnosed in 12% of travelers returning from the developing world with acute diarrhea, it says.

“E. histolytica is morphologically identical to a non-pathogenic species, E. dispar, making accurate diagnosis very difficult,” Techlab says. “Other currently available tests and microscopy cannot differentiate between the two species, frequently resulting in an inaccurate diagnosis.”