TECHLAB Receives FDA 510(k) Clearance To Market TRI-COMBO PARASITE SCREEN™ To Detect Giardiasis, Cryptosporidiosis, And Amebiasis

TECHLAB®, Inc., a leading developer and manufacturer of rapid non-invasive diagnostic tests for gastrointestinal diseases, today announced that it received U.S. Food and Drug Administration (FDA) clearance for the TRI-COMBO PARASITE SCREEN™ test. The TRI-COMBO PARASITE SCREEN ™ test provides a complete analysis for Giardia, Cryptosporidium, and Entamoeba histolytica, the three most common intestinal protozoan parasites. It specifically detects pathogenic E. histolytica and does not cross react with non-pathogenic E. dispar.

Giardia, Cryptosporidium, and E. histolytica are the most common parasitic causes of diarrhea in the United States. The TRI-COMBO PARASITE SCREEN™ test is an enzyme immunoassay for the simultaneous qualitative detection of Giardia spp., Cryptosporidium spp., and/or E. histolytica antigen in human fecal specimens. It is indicated as an aid in the diagnosis of gastrointestinal infection when giardiasis, cryptosporidiosis and amebiasis is suspected. "This new and unique assay will make testing for the three most common causes of parasitic gastroenteritis more efficient and cost-effective," said David Lyerly, Ph.D., Chief Scientific Officer, TECHLAB®.