Monday March 3 8:30 AM EDT
Highly accurate one-step H.pylori test cleared
SUNNYVALE, Calif.--(BUSINESS WIRE)--March 3, 1997-- Chemtrak Inc Monday announced that it has received FDA 510(K)
clearance for improved performance claims on its professional use H.pylori test which screens for the bacterium now believed to
cause 90 percent of duodenal ulcers.
Peptic ulcers affect approximately five million Americans each year and it is estimated that over ten percent of the population will
develop an ulcer during their lifetime.
Information supplied by the company to the FDA included data from a new ten-site independent study conducted to determine the
test's overall accuracy when compared with other methodologies. According to the results, ChemTrak's AccuMeter(r) H.pylori
system demonstrated a relative sensitivity of 91 percent in biopsy positive specimens, a relative specificity of 98 percent in biopsy
negative specimens and a relative agreement of 95 percent using fingerstick specimens compared with ELISA.
Until recent development of ChemTrak's whole blood single-use screening system, the detection of H.pylori antibodies (now
recognized as associated with a variety of gastrointestinal diseases including chronic gastritis and ulcers) often required invasive
clinical methods performed by trained personnel using sophisticated equipment. The most common invasive procedure involves
endoscopy and the collection of multiple biopsy samples.
Now, serological detection of H.pylori antibodies can be done in a non-invasive manner with ChemTrak's AccuMeter test. Distributed
by Astra Merck Inc., under the brand name Hp Chek(tm), the new screening system will soon be available for professional
applications. This FDA clearance will trigger a milestone payment to ChemTrak from Astra Merck Inc. based on the terms of their
distribution contract.
Hp Chek is a fast, accurate, one-step and user-friendly non-instrumented test. It combines the simplicity of a visual result and a
proven immunoassay method with the convenience of a single unit low-cost cassette. The AccuMeter cassette contains all the
chemistry necessary to produce test results similar to laboratory screenings. ChemTrak Inc. and Astra Merck Inc. entered into an
agreement in 1995 allowing for the distribution and supply of the company's H.pylori test in the United States and Puerto Rico. Hp
Chek will be marketed by Astra Merck's sales force. Astra Merck also markets Prilosec(tm), the prescription medication used for the
treatment of several acid-related disorders including active duodenal ulcers.
"While H.pylori bacteria afflict 40 percent of the U.S. population, in developing countries the estimate is 80 percent. Hence, this
ChemTrak test may have global applications," said ChemTrak President and Chief Executive Officer Edward F. Covell. The H.pylori
test was originally filed in a 510(K) notification to the FDA in 1996 solely for physician use. ChemTrak will be conducting consumer
test trials in order to re-submit data to the FDA for consumer use of the test. ChemTrak has also licensed the marketing rights to
Astra Merck Inc. for distribution of this important product directly to consumers.
"This latest ChemTrak screening system addresses the trend towards the introduction of highly sophisticated diagnostic technologies
to the home test arena. We are confident in Astra Merck's ability to market the product," Covell added.
Separately, Covell noted that Roger Richeal, senior vice president, will return to his prior status as a consultant to ChemTrak. He will
continue to shepherd emerging technologies and future product development through the FDA process and manufacturing scale-up.
In addition, Alene A. Holzman, vice president, will leave the company to pursue another business opportunity. Her role in the investor
relations area will be assumed by a soon-to-be-named CFO.
Currently, ChemTrak's CholesTrak Home Cholesterol Test, the first FDA-approved product of its kind, is available internationally and
in most retail pharmacies and mass merchandise outlets in the United States. While the company awaits final FDA clearance for its
Aware(tm) home HIV test system, ChemTrak recently announced the U.S. retail market entry of ColoCARE(tm), a non-invasive
home test to detect the early warning signs of colorectal disease.
"This newest ChemTrak product, along with Hp Chek, illustrates the company's prompt response to the growing personal diagnostics
market," Covell concluded.
Statements in this release that relate to product performance, customer acceptance, market conditions, and new product plans are
forward-looking statements. Actual results might differ materially from these statements due to risks and uncertainties -- including
determinations by the FDA, the impact of competitive product and pricing, and the timely development and acceptance of new
products, and medical market conditions.
CONTACT: ChemTrak, Sunnyvale
E. Covell, 408/773-8156
or
D. McCue, 714/557-3663
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