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Diagnostics FDA

 News Release - June 13, 2017

TECHLAB(R) Receives FDA 510(k) Clearance To Market E. HISTOLYTICA QUIK CHEK(TM) To Aid Clinicians In The Diagnosis Of Amebiasis Caused By The E. Histolytica Parasite

E. HISTOLYTICA QUIK CHEK™ and GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ Provide a definitive diagnosis in parasite screening

BLACKSBURG, Va., June 13, 2017 -- (Healthcare Sales & Marketing Network) -- TECHLAB,® Inc., a leading developer and manufacturer of rapid, non-invasive diagnostic tests for gastrointestinal disease, today announced that it received U.S. Food and Drug Administration (FDA) clearance for E. HISTOLYTICA QUIK CHEK™ test. E. HISTOLYTICA QUIK CHEK™ test is the only rapid diagnostic test that specifically detects pathogenic E. histolytica and does not cross react with non-pathogenic Entamoeba dispar. E. HISTOLYTICA QUIK CHEK™ test can be paired with the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test to provide a complete triple parasite screen. For more information, visit www.techlab.com.

E. histolytica is an intestinal parasite which infects an estimated 50 million people each year. Infected individuals may develop amebiasis, characterized by bloody diarrhea, colitis, and liver abscesses. The disease is fatal in up to 100,000 cases annually, and has been diagnosed in 12 percent of travelers returning from the developing world with acute diarrhea1,2,3.

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

The E. HISTOLYTICA QUIK CHEK™ test is a rapid assay for the qualitative detection of E. histolytica in fecal samples. It targets an adhesin protein unique to E. histolytica. The test can be used for quick and reliable diagnosis of amebiasis. Together with the GIARDIA/CRYPTOSPORIDIUM QUIK CHEK™ test, E. HISTOLYTICA QUIK CHEK™ test provides a rapid diagnostic screening tool for common intestinal parasites.

About 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 including C. difficile bacteria, parasitology and intestinal inflammation. TECHLAB® is headquartered in Blacksburg, Va. and manufactures all of its diagnostic tests in the United States at its state-of-the-art manufacturing facility in Radford, Va.

References
  1. Korpe, P.S. et al. (2012) Short Report: Evaluation of a Rapid Point-of-Care Fecal Antigen Detection Test for Entamoeba histolytica. Am. J. Trop. Med. Hyg. 86(6) pp. 980-981.
  2. E. HISTOLYTICA QUIK CHEK™/ Package Insert.
  3. Bercu T.E., Petri W.A., and Behm J.W. (2007) Amebic colitis: new insights into pathogenesis and treatment. Curr. Gastroenterol. Rep. 9(5) pp. 429-433.


Source: TECHLAB

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