FDA Clearance for Assay that Detects Most Virulent H.pylori Strains

Gold Standard Diagnostics (GSD) today announced FDA clearance of its Helicobacter pylori enzyme immunoassay (EIA), offering improved specificity and sensitivity for the clinical diagnosis of the most virulent strains of H. pylori that have been linked to increased risk of gastric cancer and peptic ulcer disease. GSD’s H. pylori IgG, IgA and IgM* serology tests are non-invasive, easily automated, and cost-effective.

Compared to other H. pylori diagnostic methods, serology testing offers a straightforward means to make the initial diagnosis without invasive procedures, special training or expensive equipment. The test is manufactured using propriety antigen purification and plating processes to ensure preservation of the CagA and VacA proteins expressed by the strains that pose the greatest long-term health risks to infected individuals.

Strongly linked to the development of peptic ulcers, gastric cancer and MALT lymphoma, H. pylori is thought to be the most common bacterial infection on the planet. With roughly half of the world’s population infected, the exact means of transmission remains unknown. Treatment, however, is largely effective and often leads to lifelong immunity and relief from symptoms.

GSD’s H. pylori EIA is certified as “ThunderBolt-Ready” ensuring quick and easy automation on the ThunderBolt™ EIA Platform. Additionally, over 200 other assays from 20 different manufacturers are certified as “ThunderBolt-Ready”.

*IgM is not FDA Cleared.