A novel method to detect Helicobacter pylori in children

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44DK057905-02
Agency Tracking Number: DK057905
Amount: $707,795.00
Phase: Phase II
Program: SBIR
Awards Year: 2003
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (603) 598-6960
Business Contact
Phone: (603) 598-6973
Research Institution
DESCRIPTION (provided by applicant): In the avalanche of publicity surrounding H. pylori infection, children have been the one segment of the population that has been virtually ignored. However, there is a growing body of evidence that children, and especially minority children, are commonly afflicted with this disease. There are no FDA approved tests, other than the onerous endoscopic-based tests, to detect active H. pylori in children. We intend to address this need for a simple, minimally invasive and accurate diagnostic test for children. Metabolic Solutions has developed a test to determine the presence of active H. pylori infection that we named the Ez-HBT(TM). Although this is a blood test it should not be confused with serology tests that detect the presence of antibodies. The Ez-HBT(TM) is superior to antibody based tests because it detects the presence of gastric urease activity. Urease activity is only present when H. pylori have colonized the stomach. The test begins with the patient ingesting an oral dose of 13C-urea (non-radioactive label). The enzyme urease associated with gastric H. pylori breaks urea down into 13CO2 and ammonia. This results in an increase in the ratio of 13C/12C in blood carbon dioxide if H. pylori are present in the stomach. H. pylori infection impairs a child's growth, ability to function in school and may have long term implications for gastric cancer. The simplicity of the Ez-HBT(TM) including no test meal, a tablet that can be dissolved in a glass of water and a single traditional venipuncture makes it an ideal and cost effective tool for identifying H. pylori infection in children.

* Information listed above is at the time of submission. *

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