Where do you get your infomation that CMTR will begin shipping the HP test in April? Their 4thQ report stated that: "We look forward to shipping the new HpChek test to Astra Merck this quarter and working hand-in-hand with them on this U. S. launch," said Edward F. Covell.".
Since the end of this quarter is Monday (I believe), I don't think that Chemtrak will meet their own deadline. Though this is a bit worrysome, the 3/3 press release regarding FDA substantiation of effectiveness claims may have been a prerequsite for Astra Merck's distribution. At the very least it did generate a milestone payment.
Here is a piece of the press release:
"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. "
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I certainly hope that you are correct that the H. pylori test will begin shipping in the very near future but a broken deadline from someone with a lot more information that us is a bit of a concern.
Ed |
