Corgenix Enters Contract Manufacturing Agreement with Medical Device Company

Corgenix Medical Corporation (Denver, CO, USA) has entered into a 10 year contract manufacturing agreement with EDP Biotech (EDP; Denver South, CO, USA), a medical device company. Under terms of the agreement, Corgenix will manufacture and supply the ColoMarker diagnostic test, a blood test developed to detect early stages of colon cancer.

ColoMarker combines diagnostic applications with use as a patient management tool that could help physicians determine the effectiveness of colon cancer treatment in patients. It is a simple blood test designed to identify potential cases of early stage colon cancer. The test requires no advance preparation by the patient such as fasting or colon cleansing and it can be added easily to the panel of blood tests routinely performed at a patient’s annual physical examination.

“We are pleased to enter into this mutually beneficial relationship with EDP,” said Douglass Simpson, president and CEO of Corgenix. “This reflects our strategic focus on the Contract Services portion of our business for diagnostic products, and it meets the increasing overall demand for contract services in the medical device and biotechnology industries.”

Corgenix develops and manufactures specialized diagnostic kits for immunology disorders, vascular diseases, and bone and joint disorders, including a non-blood-based test for aspirin effect. Corgenix diagnostic products are commercialized for use in clinical laboratories throughout the world. The company currently sells over 50 diagnostic products through a global distribution network and has experience in product submissions to the US Food and Drug Administration (FDA; Silver Spring, MD, USA) and other worldwide regulatory authorities.

EDP Biotech (EDP) is a medical device company, which develops and commercializes human immunodiagnostic tests. EDP has identified and purified proteins present in the early stages of biological changes for production of in vitro diagnostics tests, whose primary target is the development of early detection products.

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Corgenix Medical Corporation
EDP Biotech
FDA