ENTERIC'S HELICOBACTER PYLORI TEST GETS FDA CLEARANCE.
The new PP-CAP (R) IgA enzyme immunoassay (EIA) kit was cleared by the FDA on November 13, 2000. The product is an in-vitro qualitative test for the detection of IgA antibodies to H. pylori in human serum or plasma. H. pylori, which is estimated to infect from 30-40% of the U.S. population, has been identified as the major cause of peptic ulcers. It has also been linked to gastric cancer and has been classified as carcinogenic by the World Health Organization (WHO). The spiral shaped bacterium, which was first noticed in 1979, is able to live in the highly acidic environment of the stomach by invading the mucus sheathing of the stomach wall. Once in place, the organism appears to trigger an inflammation of the lining characteristic of gastritis, or in severe cases, an erosion of the wall that develops into ulcers.
The PP-CAP (R) assay is to be used as a second line test in the diagnosis of infection for H. pylori in adults with symptoms suggestive of gastrointestinal disease but who may have tested negative for IgG antibodies to the bacterium. The PP-CAP (R) assay should be performed and interpreted in conjunction with the company's HM-CAP (R) EIA test for IgG antibodies to H. pylori. The PP-CAP (R) kit utilizes a proprietary antigen and has demonstrated a sensitivity of 93.1 % and a specificity of 89.0 % when compared to a combination reference method that includes the urea breath test and the HM-CAP (R) test.
According to Anthony A. Lombardo, E-Z-EM's President and CEO, "Our new PP-CAP (R) assay gives the practitioner an important new method of diagnosing H. pylori infection in patients. It essentially provides an additional tool for completing the diagnostic puzzle and will allow for the proper treatment of conditions such as gastric and duodenal ulcers and chronic gastritis.
"The body produces different antibodies, each of which serves as a vital part of its immune system arsenal. Existing blood tests, such as our HM-CAP (R) assay, detect only IgG antibodies. This single-antibody focus may cause some patients to go undiagnosed and untreated. Our new PP-CAP (R) assay will test for another antibody, IgA, and will offer the physician a more complete picture of antibody response when used in conjunction with HM-CAP (R). Being the first to offer a proprietary IgA test for this globally recognized disease fits well into our strategy to become a world leader in the digestive health diagnostics marketplace."
The PP-CAP (R) IgA kit will be marketed both directly and through Sigma Diagnostics and Alexon-Trend in the United States and Europe. The company plans to market this product in Japan through Kyowa Medex Co. Ltd. when Japanese regulatory approvals are received.
E-Z-EM, Inc., is the world's largest manufacturer of diagnostic contrast agents and related imaging accessories for gastrointestinal radiology. The company's wholly-owned subsidiary, AngioDynamics, Inc., manufactures a wide range of products, including angiographic, thrombolytic, vascular access, and drainage products, as well as stents and medical devices for angioplasty. Another subsidiary, Enteric Products, Inc., develops, manufactures and markets tests for detection of the ulcer-causing bacterium Helicobacter pylori.
For additional information, call 1-800-544-4624, ext. 325, or visit http://www.ezem.com.
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|Comment:||ENTERIC'S HELICOBACTER PYLORI TEST GETS FDA CLEARANCE.|
|Date:||Jan 1, 2001|
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