If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Breath Test for Detecting Ulcer-Causing Bacterium Cleared by FDA NASHVILLE, Tenn., Sept. 19, 1996 -- Today, Meretek, Inc. announced receipt of market clearance and approval for their innovative diagnostic breath test for detection of the ulcer-causing bacterium, Helicobacter pylori, by the Food and Drug Administration (FDA). The MERETEK UBT(TM) Breath Test for H. pylori is the first and only breath test for diagnosis of H. pylori cleared and approved in the United States utilizing patented non-radioactive technology. The MERETEK UBT Breath Test for H. pylori provides a uniquely simple, non-invasive, accurate and cost effective means for direct detection of an active infection of the H. pylori bacterium so appropriate treatment can be prescribed and an ulcer can be cured. In a multi-center study published earlier this year in the American Journal of Gastroenterology, the MERETEK UBT Breath Test detected the presence or absence of H. pylori with 95 percent accuracy. A Long-Awaited Diagnostic Alternative Until now, the only way to accurately diagnose active H. pylori infection has been endoscopy with stomach biopsy -- a costly, invasive and uncomfortable procedure that involves sedating the patient, inserting a tube into the stomach and removing a sample of the stomach lining for analysis. Blood tests are designed to detect antibodies to the bacterium and are invasive, requiring a needle puncture. These tests can't always reliably determine if a patient is actively infected. Antibodies remain in the blood after a previous exposure or infection for many months and can be detectable via blood test, even if an infection is not present in the stomach. In striking contrast, accurate diagnosis with the MERETEK UBT Breath Test is easily achieved at a fraction of the cost of endoscopy with stomach biopsy. Now a patient can be reliably diagnosed for H. pylori without this invasive procedure. According to Claudia Hitchcock, President and CEO of Meretek, Inc., "This decision by the FDA is a momentous milestone for our company and paves the way for the introduction of this breakthrough technology through our first product. We have initiated our plans to make the product available to physicians later this fall. We are excited by the FDA's clearance of our application. This test provides the missing piece in the disease management model for ulcer disease. People can now be easily tested and treated, which will ultimately provide the predicted cost reductions for this disease." This simple, painless procedure can be performed with Meretek's UBT Breath Test Collection Kit in the doctor's office and takes about 30 minutes to complete. The patient drinks a new non-radioactive diagnostic drug, Pranactin(TM) solution, and then exhales breath samples into a specially-designed collection device. The kit also contains the components to send the breath samples to Meretek for analysis, with results promptly provided to the physician. Meretek has established a centralized testing facility in Nashville, TN, which, along with its Houston, TX, research facility, will provide this service to physicians and healthcare providers. The company anticipates expansion of its facility as well as license opportunities for those clinical settings who may wish to perform the analysis on-site. Patented, Non-Radioactive Breath Test Technology Unlike another manufacturer's breath test which is still in the investigational stage, the MERETEK UBT Breath Test for H. pylori is entirely non-radioactive. Meretek's diagnostic Pranactin drug uses carbon 13 (13 C) enriched urea, a naturally occurring, non-radioactive compound to determine the presence or absence of an active infection. Easy on the Patient Said Bergein F. Overholt, M.D., President of Gastrointestinal Associates, P.C., in Knoxville, TN, "The MERETEK UBT Breath Test provides a long-awaited means for detecting H. pylori infection accurately and cost effectively, in a manner that's safe and painless for the patient. The availability of this significant medical advancement for diagnosis of patients with H. pylori infection has been anticipated within the medical community because of the increasing awareness of the risks associated with this pathogen." The groundbreaking discovery of the causal role of H. pylori in peptic ulcer disease is causing a paradigm shift in how ulcers are diagnosed and treated. Peptic ulcer disease -- a condition characterized by chronic inflammation and painful sores in the lining of the stomach or part of the small intestine -- afflicts millions of Americans every year. An estimated 10 percent of the American population is affected by peptic ulcer disease at some point in their lives, and an estimated 35 percent of the adult population is infected by this bacterium. "Accurate detection of the presence or absence of this infection is critical to successful therapy," said David Y. Graham, M.D., Professor of Medicine and Molecular Virology, Chief of Digestive Diseases at Baylor College of Medicine, Houston, TX, and head of Gastroenterology at Methodist Hospital, Houston. With the approval of the MERETEK UBT Breath Test, we now achieve a conclusive diagnosis with technology that is safe for the patient and easy to use." As stated by Kerry Bush, Vice President and COO of Meretek, Inc., "Today's environment demands medically sound patient care which must be cost effective. Indiscriminate use of antibiotics without proper diagnostic assessment results in greater patient suffering and higher medical costs. This test is the only alternative to endoscopy/biopsy procedures for reliable direct detection of the presence or absence of active H. pylori infection." Meretek is principally engaged in the development of simple, non-invasive, non-radioactive breath tests that result in a better quality of life. The company holds exclusive licenses to patents involving non-radioactive breath test technologies. Meretek is headquartered in Nashville, TN, with research and development facilities in Houston, TX. Customers can call 1-888-MERETEK (1-888-637-3835) for more information about the MERETEK UBT Breath Test for H. pylori.
|
