PRESS RELEASE: TECHLAB® Receives FDA 510(k) Clearance To Market TRI-COMBO PARASITE SCREEN™ To Aid Clinicians In The Diagnosis Of Giardiasis, Cryptosporidiosis, And Amebiasis
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BLACKSBURG, Va., July 13, 2017 /PRNewswire/ — 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. dispar1,2. For more information, visit www.techlab.com.
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 suspected3. “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®.
TECHLAB®, Inc. (www.techlab.com) has been a leading developer and manufacturer of intestinal diagnostics products in the United States for 27 years. The Company has a market leading portfolio of diagnostic tests for enteric diseases caused by C. difficile, Shiga toxin producing E. coli, and protozoan parasites. TECHLAB® also manufactures diagnostic tests for intestinal inflammation. TECHLAB®® is headquartered in Blacksburg, Va. and manufactures its diagnostic tests in the United States at its state-of-the-art manufacturing facility in Radford, Va.
- Christy N.C. et al. (2012) Multisite Performance Evaluation of an ELISA for Detection of Giardia, Cryptosporidium, and Entamoeba histolytica Antigens in Human Stool. J Clin Microbiol 50(5) pp. 1762-32.
- Den Hartog J. et al. (2013) Diagnosis of Multiple Enteric Protozoan Infections by Enzyme-Linked Immunosorbent Assay in the Guatemalan Highlands. Am J Trop Med Hyg 88(1) pp.167-71.
- TRI-COMBO PARASITE SCREEN™/ Package Insert.