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One-Step H. Pylori Test Cleared for Marketing WAYNE, Pa., March 3, 1997 -- HpChek(TM), a whole-blood, one-step, single-use, physician's office test to confirm the presence of H. pylori in patients with active duodenal ulcer, has received FDA clearance for improved performance claims. H. pylori is the bacterium believed to cause about 90 percent of duodenal ulcers. Data from a 10-site independent study conducted to determine the test's overall accuracy showed that HpChek demonstrated a relative sensitivity of 91% in biopsy-positive specimens, a relative specificity of 98% in biopsy-negative specimens and a relative agreement of 95% using fingerstick specimens compared to ELISA. H. pylori infection, one of the most common bacterial infections in humans, is the primary cause of peptic ulcers, affecting approximately five million American each year. In the past, ulcers were believed to be caused by lifestyle factors such as stress and diet. Researchers now know that the H. pylori bacterium, along with acid secretion, damages stomach and duodenal tissue, causing inflammation and ulcers in 90% of ulcer patients. Until the recent development of ChemTrak's serologic single-use screening system, the detection of H. pylori often required invasive clinical laboratory methods, such as endoscopy and the collection of biopsy samples, performed by trained personnel using sophisticated equipment. HpChek is a fast, easy-to-use, non-instrumented test for physicians' office use which confirms the presence or absence of the H. pylori antibodies in less than 10 minutes. The HpChek test is expected to be available to physicians in April, 1997. The test was developed by ChemTrak Inc. of Sunnyvale, CA, and will be marketed by Astra Merck Inc. E-mail this page to a friend or colleague! To print, use this version