ChemTrak Gets US Appro for H pylori kit

ChemTrak has been granted marketing clearance in the USA for its rapid test for Helicobacter pylori, a bacterium thought to be a primary cause of peptic ulcers and gastritis, and which has been linked to gastric cancer.

ChemTrak's test is an inexpensive, disposable, single-use, whole-blood vehicle that renders a yes-or-no result on the presence of H. pylori antibodies within nine minutes. The test has received marketing clearance for use by doctors and other clinicians in office or clinical settings.

The kit will be marketed in the USA by the Astra Merck joint venture, which expects to market the test under the tradename Hp Chek directly to physicians and clinical institutions as a companion product for its anti-secretory prescription medication Prilosec (omeprazole), a leading treatment for ulcers. ChemTrak's agreement with Astra Merck also grants the right to market the test in the non-prescription, over-the-counter market, for which ChemTrak will seek separate FDA clearance.