US FDA clears Otsuka's H pylori Rapirun test

Japan, Tokyo-based Otsuka Pharmaceutical has received US Food and Drug Administration clearance to market the Rapirun Helicobacter pylori antibody detection kit, the first test available in America for identifying, in patient urine rather than blood, anti-IgG antibodies against the pathogen, which is the cause of most stomach and duodenal ulcers.

According to Otsuka, the Rapirun kit is a rapid immunochromatographic assay intended for the qualitative detection of antibodies against H pylori in urine to aid in the diagnosis of infection. The kit is suitable for use in both point-of-care and clinical laboratory settings and is also easy to administer, economical and convenient for the patient, the firm noted. Non-invasive testing for screening of H pylori infection is preferred over methods that require endoscopy as approximately 81% of dyspeptic patients presenting to primary care receive noninvasive testing in the USA.

Methods of diagnosis include testing for specific anti-H pylori IgG antibodies, urea breath tests and stool antigen tests. Otsuka's other other products in the field of H pylori diagnostics feature most of these options. Its offerings includes the BreathTek UBT C-urea breath test and the UBiT-IR300 and POCone Infrared spectrometer for measuring changes in the carbon isotope ratio (13CO2/12CO2) in breath.