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.
“MPO tests, which were originally designed for research purposes only, are not as accurate as what is needed in patient care settings,” Dr. Hazen said. “The CardioMPO blood test developed and marketed by PrognostiX is accurate and reliable in the diagnosis and treatment of patients.”
PrognostiX is housed within the Clinic’s innovation center located at 10265 Carnegie Ave. A Technology Action Fund grant made to The Cleveland Clinic by the State of Ohio helped to support the Clinic’s innovation center, which played a key role in developing PrognostiX as a Cleveland Clinic-owned spin-off company. ExOxEmis, of Little Rock, Ark., is a principal investor in PrognostiX. The Clinic is a shareholder in PrognostiX and members of its staff also have a financial interest in the company.
In addition to CardioMPO, PrognostiX is working to develop several additional technologies for the diagnosis and treatment of cardiovascular and other inflammatory diseases, including asthma.