PRESS RELEASE: TECHLAB® Receives FDA 510(k) Clearance to Market H. PYLORI QUIK CHEK™ and H. PYLORI CHEK™ Tests
BLACKSBURG, Va. – Aug. 21, 2018 – 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 H. PYLORI QUIK CHEK™ and the H. PYLORI CHEK™ tests. Both are designed to aid in the diagnosis of H. pylori infection, a disease which affects half the population of the world.1 The disease is responsible for most duodenal and gastric ulcers and is associated with a two to three fold increased risk of gastric cancer and mucosal associated-lymphoid-type lymphoma.2 The H. PYLORI QUIK CHEK™ test is a rapid diagnostic test that detects H. pylori in 30 minutes. The H. PYLORI CHEK™ test is a 96-well plate format diagnostic for laboratories testing large numbers of specimens and can be performed with or without automation in one hour. The H. PYLORI CHEK™ and H. PYLORI QUIK CHEK™ tests exhibit strong performance and offer flexible transport conditions including room temperature storage of specimens and the use of C&S and Cary Blair transport media to simplify sample collection for patients and physicians.
“Our tests were compared against histology and urease testing performed on biopsies collected during endoscopy as both an initial diagnostic and a test of cure. Both assays provide excellent clinical performance. We are proud of TECHLAB’s quality diagnostic assays,” said Dr. Joel Herbein, VP of Scientific Affairs at TECHLAB.
H. pylori has a seropositivity rate of 36 percent in the United States.1 For that reason, the American College of Gastroenterology recommends a test that detects current disease, such as stool antigen testing, rather than serology. The H. PYLORI QUIK CHEK™ and H. PYLORI CHEK™ tests offer quick and reliable detection of H. pylori-specific antigen in human fecal specimens.3
TECHLAB, Inc. (www.techlab.com) has been a leading developer and manufacturer of intestinal diagnostics products in the United States for 28 years. The Company has a market-leading portfolio of diagnostic tests for enteric diseases caused by C. difficile, food-borne pathogens, 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.
1. Talley N. 2005. AGA Medical Position Statement: Evaluation of dyspepsia. Gastroenterology 129:1753-1755.
2. Burkitt MD, Duckworth CA, Williams JM, Pritchard DM. 2017. Helicobacter pylori-induced gastric pathology: insights from in vivo and ex vivo models. Disease Models & Mechanisms 10:89-104.
3. Chey WD, Leontiadis GI, Howden CW, Moss SF. 2017. ACG Clinical Guideline: Treatment of Helicobacter pylori, Infection Am J Gastroenterol 112:212-238.