Corgenix submits Premarket Notification to FDA for AspirinWorks Test Kit for cardiovascular disease

By Lisa Kerner

Charlotte, N.C., July 20 - Corgenix Medical Corp. submitted a Premarket Notification (510k) to the Food and Drug Administration for its AspirinWorks Test Kit, a diagnostic product for cardiovascular disease. The company also has U.S. patent pending on the product.

The quantitative enzyme-linked immunoassay measures levels of 11-Dehydro Thromboxane in urine to gauge an individual's response to aspirin dosage. Physicians can then adjust aspirin dosage or recommend alternative therapy, accordingly.

The AspirinWorks product was developed in conjunction with Corgenix' strategic partners, Creative Clinical Concepts, a Denver-based biotechnology company, and Cayman Chemical Co., an Ann Arbor, Mich. manufacturer of biochemical research products.

Corgenix and Creative Clinical licensed proprietary technology owned by McMaster University in Hamilton, Ont., for the development of diagnostic tests specific to the pathway by which aspirin acts on platelets.

Denver-based Corgenix develops diagnostic kits for immunology disorders, vascular diseases and bone and joint disorders.

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