June 4, 2007 — Corgenix Medical Corporation, a worldwide developer and marketer of diagnostic test kits, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its AspirinWorks Test Kit, the Company's newest diagnostic product.
More than one million Americans experience new or recurrent heart attacks each year. At risk individuals are eligible for aspirin therapy and should be tested for the presence or absence of the therapy's effect.
The AspirinWorks Test Kit is an enzyme-linked immunoassay (ELISA) to determine levels of 11-Dehydro Thromboxane B2 (11dhTxB2) in human urine, which aids in the qualitative detection of aspirin effect in apparently healthy individuals post ingestion.
"The 510(k) clearance of AspirinWorks is an enormous milestone for our company and important to the health of millions in the U.S. in addition to the rest of the world," said Douglass Simpson, Corgenix President and Chief Executive Officer. "We have significant expectations for this product due to the strong interest it has already attracted from the investment and health care communities. We believe that this product, in the intermediate-to long term, has the potential to generate worldwide revenues equal to or in excess of all of our other products combined."
The AspirinWorks diagnostic test kit targets a potential U.S. market of over 60 million individuals and a potential global market exceeding 200 million individuals.
Simpson said the new test kit, already CE marked and available in Europe, will be sold through Corgenix U.S. sales force and distributed through its established network of laboratories.
"Research has shown that up to 25 percent of individuals may be non-responsive to aspirin's benefits, and are more than three times more likely to die from heart disease," said Corgenix Clinical Affairs Director Gordon Ens. "This test can tell us if the aspirin fails to elicit an effect, thereby allowing physicians to individualize their patient's therapy."
Unlike other platelet aggregation tests, which require freshly drawn blood that must be evaluated within at least 4 hours, the AspirinWorks test requires a urine sample that can easily be obtained in any doctor's office. Ens believes that any doctor should be able to order the AspirinWorks test now that FDA clearance has been received.
"This can not come at a better time considering the recent American Heart Association (AHA) guidelines that suggest that women should consider an aspirin regimen to reduce their potential risk of heart attack and stroke," stated Ens.
For more information visit: www.corgenix.com