Aug. 26, 1997 ROCHESTER, MINN. -- An exciting medical advance is allowing ulcer sufferers to breathe a sigh of relief. Until now, biopsy of the stomach lining has been the only certain way to diagnose an active infection which is believed to be a primary cause of peptic ulcer disease. Today the Meretek UBT(tm) Breath Test for H. pylori with Pranactin(tm) diagnostic drug provides a safe, painless, accurate and cost-effective way of determining the presence of this infection. Mayo Medical Laboratories (MML) is the first test center licensed by Meretek to offer this new procedure.
H. pylori (Helicobacter pylori) infection is a primary cause of peptic ulcer disease, which causes pain and expense to millions of patients and their healthcare providers each year. Accurate and direct detection of active H. pylori infection is the first step toward diagnosing the cause of painful symptoms and curing peptic ulcer disease. Previously, this required an endoscopic procedure in which the sedated patient swallowed a tube with a light at its end and samples of stomach lining were obtained. The new test can be administered right in the physician's office, replacing the need for biopsy, a procedure that is invasive, costly and uncomfortable.
"Accurate detection of an active H. pylori infection is crucial for selecting the right treatment for patients with indigestion or upper abdominal pain," said Dr. Michael Camilleri, gastroenterology consultant and professor of medicine and physiology at Mayo Clinic. Treatment of peptic ulcer disease usually involves prescribing antibiotics. Patients who are diagnosed with the H. pylori infection will have this condition treated, and many will experience an end to their painful stomach symptoms. Accurate diagnosis and appropriate treatment of patients with positive tests will also prevent people without ulcers from indiscriminate antimicrobial treatment which may result in development of resistance to antibiotics from unnecessary use.
The Meretek UBT(tm) is as accurate as endoscopy with biopsy in detection of H. pylori infection. In addition, because the test assesses the entire stomach area as opposed to selective, random tissue, the chances of missing an infection are greatly reduced. Finally, it is a direct detection method, unlike serology, which detects antibodies to the bacterium in the blood, but cannot always reliably determine if a patient is currently infected.
The patient drinks a clear, tasteless solution which is non-radioactive and uses only naturally-occurring compounds. The drug solution contains carbon-13 enriched urea and water. In the presence of an active H. pylori infection, urease hydrolyzes the carbon-13 enriched urea to form ammonia and carbon-13 enriched carbon dioxide, which is detectable in the patient's breath samples. Breath samples are collected from the patient before and after the physician administers the Pranactin(tm) diagnostic drug solution. The collected samples are then sent to Mayo Medical Laboratories for analysis.
Mayo Medical Laboratories (MML) is the reference laboratory of Mayo Clinic, located in Rochester, Minn. MML has supported community-based laboratory medicine for over 25 years with reference testing services of high value, accountability and quality. Mayo's staff of nationally recognized laboratory experts, and Mayo Clinic's 1,400 physicians and scientists provide consultation on test selection, utilization and result interpretation. MML's reference services complement and support laboratory services at a local and a regional level.
Meretek is a specialized healthcare company engaged in the development of simple, non-invasive, non-radioactive breath tests using safe diagnostic drugs. The company holds exclusive licenses to patents involving non-radioactive breath test technologies. Meretek is headquartered in Nashville, Tenn., with research and development facilities in Houston, Texas, and breath test centers in Nashville and Houston.
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