Corgenix seeks US OK for AspirinWorks:
This article was originally published in Clinica
Executive Summary
Denver, Colorado company Corgenix Medical has submitted to the US FDA a 510(k) application to market its urine test kit for assessing the effectiveness of aspirin when used as a preventive therapy for cardiovascular disease. The AspirinWorks kit, a quantitative ELISA test that determines levels of 11-dehydro thromboxane B2, measures an individual's response to aspirin dose and allows physicians to adjust the dose or recommend alternative therapy, said the firm. The company added that recent reports indicate that up to 25% of individuals may be non-responsive to aspirin's benefits, and are over three times more likely to die from heart disease. The kit, which was launched outside the US a few weeks ago, was developed jointly by Corgenix, fellow Denver firm Creative Clinical Concepts and Ann Arbor, Michigan-based Cayman Chemical Company.
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