FDA Approves Effective New Test For Underlying Cause Of Ulcers

(Boston, Mass.) — A new test to diagnose active H. pylori infection, the leading cause of peptic ulcer disease, recently received clearance from the Food and Drug Administration. Developed by Boston University's Stable Isotope Laboratory, the technology was exclusively licensed by the Boston University Technology Fund to Metabolic Solutions, Inc. (MSI) of Nashua, N.H. who will market the test under the name Ez-HBTTM. Scientists at the University of California at San Francisco, and the Veterans Administration Medical Center in Palo Alto also participated in the development of the underlying technology.

Ez-HBTTM is the first diagnostic tool that can accurately detect active H. pylori infection by means of a simple blood test administered in a doctor's office. Current blood tests rely on antibody detection and cannot distinguish between active and past infection. Ez-HBTTM is part of a new generation of medical diagnostic tests that interact with a pathogen or an enzyme to produce compounds that can be easily detected in breath or blood samples. These tests can alert physicians to the presence of disease or allow them to monitor the health of an organ. Currently, MSI is using this technology to develop other tests that can assess liver and pancreas function, determine the gastric emptying rate, and detect bacterial overgrowth in the small intestine.

One of the most significant advancements in gastrointestinal medicine in the last decade has been the discovery of H. pylori's role in causing chronic active gastritis and peptic ulcer disease. By enabling accurate diagnosis of the underlying cause of peptic ulcer disease, Ez-HBTTM allows doctors to prescribe appropriate treatment and monitor its progress, saving significant health care dollars and producing better patient outcomes.

Ez-HBTTM is simple to use. A small oral dose of 13C-urea (non-radioactive label) is ingested by the patient. In the presence of H. pylori, the bacterial enzyme urease converts urea to 13CO2 (a labeled carbon dioxide) and ammonia. The 13CO2 is absorbed into the bloodstream and thirty minutes after administering the dose, a single blood sample is drawn in a standard blood collection tube. This tube is sent to a laboratory where the carbon dioxide is extracted from the blood and analyzed using an isotope ratio mass spectrometer to detect the presence of 13C. The presence of 13C indicates active infection.

The test was exclusively licensed to MSI by Boston University's Community Technology Fund. It was supported in part by the Small Business Innovative Research (SBIR) program of the National Institutes of Health.

About Metabolic Solutions, Inc.

Incorporated in 1990 and located in Nashua, N.H., MSI provides analytical and consulting services to biomedical researchers interested in using stable isotope tracer techniques. MSI was the first business in the United States to clinically apply stable isotope technology. Its client list boasts more than 350 researchers from nine countries, including many top tier research universities and major pharmaceutical companies. The company has received $6 million from the National Institutes of Health's Small Business Innovative Research grant program to develop medical diagnostic tests. For further information: call 603/598-6960; http://www.metsol.com

About Boston University's Community Technology Fund Community Technology Fund (CTF) provides venture capital and access to Boston University's scientific and technical resources for growing businesses. Boston University, through CTF, was one of the first universities to develop a focused venture capital and technology transfer program. CTF began investing in 1975 and has held equity positions in over 125 companies in the United States, through direct investments in venture deals and as a limited partner in Venture Funds. CTF also manages the Technology Transfer Program at Boston University and assists the University's faculty in identifying, protecting, and commercializing the University's intellectual property. CTF is actively engaged in start-up and spin out companies based on Boston University faculty inventions. For further information: http://www.bu.edu/ctf/