More competition??
Meretek Commences Shipment of Revolutionary Breath
Test For Detecting Ulcer-Causing Bacterium
Commercial Roll-Out of Non-Radioactive MERETEK UBT(TM) Breath
Test Underway with Product Shipment to Key Gastroenterologists
Nationwide
NASHVILLE, Tenn., March 24 /PRNewswire/ -- 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(TM) 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(TM) 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(TM)
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 percent over endoscopic methods, which cost on
average $1,200 to $1,500. Breath samples are sent to Meretek's Breath Test Centers for
analysis, negating the need for in-office licenses or instrumentation.
The MERETEK UBT(TM) 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 began, "We have long-awaited a safe, reliable
alternative to endoscopy. The MERETEK UBT(TM) Breath Test obtains an accurate diagnosis
of active H. pylori infection in a non-invasive, non-radioactive, and cost-effective manner. With
this breath test, we can confidently prescribe appropriate treatment so the patient can be cured."
Hughes is a Gastroenterologist and Medical Director at Kelsey-Seybold Clinic, a
Houston-based multi-specialty clinic.
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 percent 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.
Meretek has a toll-free number, 1-888-MERETEK, for physicians seeking product information
and test kits.
Meretek is a privately held company. The company is principally engaged in the development of
non-invasive, non-radioactive breath tests that result in a better quality of life. Meretek holds
exclusive licenses to patents involving non-radioactive breath test technology.
The company continues its plans for clinical trials for new applications of the breath test
technology. This includes trials studying the efficacy and safety of Pranactin(TM) diagnostic drug
and the MERETEK UBT(TM) Breath Test procedure for use in pediatric patients. In addition
to the MERETEK UBT(TM) Breath Test for H. pylori, the company has other breath test
products scheduled for clinical trials this year, including one to assess liver function and another
to measure the speed of gastric emptying, a problem associated with diabetes.
Meretek is headquartered in Nashville, Tennessee, with research and development facilities in
Houston, Texas, and breath test centers in Nashville and Houston.
NOTE: B-roll, photography, and background material are available to the media by request.
SOURCE Meretek |
