| If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| | | ![]() Meretek Commences Shipment of H. Pylori Breath Test NASHVILLE, Tenn., March 24, 1997 -- Meretek announced the company has commenced initial U.S. roll-out of the Meretek UBT(TM) Breath Test for H. pylori, with product shipment now under way to key customers in the physician marketplace. With this milestone, the revolutionary diagnostic test for the bacterial infection associated with peptic ulcer disease is commercially available for the first time. Cleared and approved by the Food and Drug Administration in September 1996, the Meretek UBT Breath Test with Pranactin(TM) diagnostic drug is the first and only non-invasive, non-radioactive diagnostic to directly detect the presence or absence of active H. pylori infection as accurately as endoscopy with stomach biopsy -- an invasive and costly procedure that involves passing an instrument fitted with a camera through the patient's mouth into the stomach area. A striking contrast to endoscopic methods, the painless, non-invasive and non-radioactive Meretek UBT Breath Test involves having the patient exhale one or two strong breaths into a patented breath collection device before and after drinking the new Pranactin diagnostic drug solution. The test can be performed in the doctor's office in about 30 minutes -- at a savings of approximately 70 to 80% over endoscopic methods. Breath samples are sent to Meretek's Breath Test Centers for analysis, negating the need for in-office licenses or instrumentation. The Meretek UBT Breath Test is the only diagnostic technology of its kind for H. pylori to utilize a non-radioactive drug. "This product provides an added benefit because it avoids any concerns associated with radioactive tests," said Gary Falk MD, Gastroenterologist at the Cleveland Clinic. "Meretek has commenced shipment to physician practices," said Claudia Hitchcock, President and CEO of Meretek. On a parallel track, Meretek's proactive efforts with physicians and the payer community to establish coverage for the breath test have made great strides, according to Kerry Bush, Chief Operating Officer for the company. "Physicians and payers have been very enthusiastic as the test can demonstrate improved patient outcomes," said Bush. Said John I. Hughes, MD, one of the first gastroenterologists to incorporate the breath test procedure into clinical practice since shipping Said Terry Litchfield, Executive Director of Kelsey-Seybold Foundation, "The foundation was very excited to be a research partner in the development and trials of this new test. We feel this important new test will change the way people perceive stomach disorders." In a national multi-center study published in the American Journal of Gastroenterology, the Meretek UBT(TM) Breath Test was shown to detect the presence or absence of H. pylori with 95% accuracy. Stomach biopsy selects only certain samples for testing. With Pranactin(TM) diagnostic drug, the Meretek UBT(TM) Breath Test assesses the entire stomach area, reducing the chance of missing an H. pylori infection. Unlike serology or blood tests, the breath test is a direct detection method for active infection. Serology or blood tests cannot always reliably detect active infection.
|