PrognostiX, a start-up company based on Cleveland Clinic technology, has received approval from the U.S. Food and Drug Administration to begin selling a diagnostic test capable of identifying patients who are in imminent danger of heart attack or death.
“Receiving FDA approval to market the blood test under the name CardioMPO is a major milestone for the company and The Cleveland Clinic,” said Christopher Coburn, executive director of CCF Innovations, the technology transfer and commercialization arm for the Clinic. “The CardioMPO test will be available for the benefit of physicians and patients in August 2005.”
CardioMPO measures the level of myeloperoxidase (MPO), a disease-fighting enzyme, in the bloodstream. Researchers at The Cleveland Clinic have found that among patients complaining of chest pain or discomfort, an elevated MPO level in blood can signal a person’s near-term risk for having a heart attack, needing bypass surgery or angioplasty, and even their risk for cardiac death, within months.
“One of the most common yet challenging situations in an emergency room or physician office is triaging a patient complaining of chest pain or discomfort,” said Marc Penn, M.D., Ph.D., medical director of the Coronary Intensive Care Unit at The Cleveland Clinic. “In these cases, physicians must quickly identify who is at risk of suffering a heart attack or in need of more aggressive intervention. The CardioMPO test will provide physicians more accurate identification of patients at risk.”
The CardioMPO blood test is based on research studies performed by Stanley Hazen, M.D., Ph.D., section head of Preventive Cardiology and Cardiac Rehabilitation at The Cleveland Clinic, in collaboration with Dr. Penn and Marie-Luise Brennan, Ph.D.