ChemTrak files for FDA clearance of H.pylori test.

SUNNYVALE, Calif.--(HealthWire)--Feb. 5, 1996--ChemTrak Inc. (NASDAQ:CMTR) has filed a 510(k) notification to obtain marketing clearance for a Helicobacter pylori (H.pylori) test with the Food and Drug Administration (FDA).

H.pylori infection, one of the most common bacterial infections in humans, is thought to be the primary cause of peptic ulcers.

In 1995, ChemTrak entered into an exclusive distribution and supply agreement for the U.S. market with pharmaceutical innovator Astra Merck. The H.pylori test will be marketed as a companion product to Prilosec(r) (omeprazole), which is commonly used for treatment of ulcers. The company intends to make the test available to physicians first, then to seek FDA 510(k) clearance for a consumer self-test similar to ChemTrak's CholesTrak(tm) Cholesterol Test.

H.pylori, which afflicts an estimated 40% of the U.S. population, is found in approximately 90% of patients with duodenal ulcers and 70% of patients with gastric ulcers. Research shows that once H.pylori is eliminated, the average one-year recurrence rate is approximately 10%, compared to a 50% to 70% recurrence rate for ulcers treated with anti-ulcer drugs alone.

"Each year, there are over 40 million office visits for gastritis in the U.S. alone," said Alene Holzman, vice president of ChemTrak. "Last year, the worldwide market for H2 antagonist ulcer medications exceeded $7 billion. Numbers like these indicate tremendous potential for our H.pylori test."

Currently, H.pylori is detected either through endoscopy procedures performed by physicians, or by experimental breath tests using special equipment. Clinical laboratories now perform a growing number of direct immunoassays for the antibodies to H.pylori in serum samples. The ChemTrak test will be a one-step, whole blood test that will indicate the presence or absence of H.pylori antibodies in minutes during a doctor's office visit.

According to Holzman, "The ChemTrak test is very quick. Other H.pylori tests are much more complicated, involving reagents, venipuncture and other procedural protocols. And, of course, it makes much more sense to administer a simple, accurate test than to perform an endoscopy."

In addition to the H.pylori test, ChemTrak markets CholesTrak(tm), today's only FDA-cleared home cholesterol self-test, to consumers nationwide.

The company has also developed a "good" cholesterol test for High Density Lipoprotein (HDL), which has been cleared by the FDA for professional use. Beyond these innovative tests, ChemTrak is one of three companies to have developed a confidential, anonymous HIV home reference test, which also includes a professional counseling service. FDA clearance is anticipated in 1996.

ChemTrak is a full-service personal diagnostics company that develops and manufactures reliable and easy-to-use home testing systems. ChemTrak test kits are designed to screen and diagnose health conditions with accuracy comparable to physician office and laboratory instrumented tests. The company markets its products to over-the-counter and professional markets worldwide, directly and through strategic alliances with established healthcare and consumer products companies.

NOTE TO EDITORS: Statements in this release that relate to product performance and 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 products and pricing, the timely development and acceptance of new products and medical market conditions.

CONTACT: Freeman/McCue Public Relations

Jon Garner/Daniel McCue, 714/557-3663

or

ChemTrak Inc.

Alene A. Holzman, 408/773-8156