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Techlab Parasite Screen Test Passes FDA Muster

NEW YORK (360Dx) – Gastrointestinal diagnostics firm Techlab today announced the US Food and Drug Administration cleared its Tri-Combo Parasite Screen test for marketing in the US.

The enzyme immunoassay provides a complete and simultaneous analysis for the three most common intestinal protozoan parasites, Giardia, Cryptosporidium, and Entamoeba histolytica. The human stool-based test is indicated as an aid in diagnosing gastrointestinal infection when giardiasis, cryptosporidiosis, and amebiasis is suspected, and specifically detects pathogenic E. histolytica without cross-reacting with non-pathogenic E. dispar, Techlab said.  

Last month, the Blacksburg, Virginia-based company said it received 510(k) clearance for its rapid Entamoeba histolytica infection test.