TECHLAB, Inc. Receives FDA 510(K) Clearance to Market E. Histolytica Quik Chek to Aid Clinicians in the Diagnosis of Amebiasis Caused by the E. Histolytica Parasite
June 13, 2017 at 09:00 am
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TECHLAB Inc. announced that it received U.S. Food and Drug Administration 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. 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% 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.
Techlab Inc. (Techlab) is a medical device diagnostic product manufacturer. The Company develops and manufactures intestinal diagnostics worldwide. Techlab manufactures a variety of in vitro enteric diagnostics to determine Clostridium difficile, Escherichia coli, parasites, IBD/IBS and other issues. The Company is engaged in formulation, testing, and packaging of diagnostic products. The Company serves pharmaceutical, diagnostic, and food processing companies. Techlab is also engaged in food additive testing and MIC testing for difficult-to-grow bacteria, such as fastidious anaerobe isolates from humans and animals. The Companyâs diagnostics include C difficile diagnostics, intestinal inflammation, parasitology diagnostics, shiga toxins diagnostics and C. perfringens diagnostics. TechLab manufactures ELISAs for common intestinal parasites. Techlab offers diagnostic tests for colitis, parasitology, intestinal inflammation, and Shiga toxins of enterohemorrhagic E. coli.
TECHLAB, Inc. Receives FDA 510(K) Clearance to Market E. Histolytica Quik Chek to Aid Clinicians in the Diagnosis of Amebiasis Caused by the E. Histolytica Parasite