Since the first publication of its study results in the New England Journal of Medicine (NEJM) in October 2003, a technology that detects an enzyme from "culprit lesions" of the heart — developed at The Cleveland Clinic (Cleveland) to determine patients who are in imminent danger of heart attack or death (Diagnostics & Imaging Week, Oct. 30, 2003) — has recently been approved by the FDA.
The in vitro diagnostic, CardioMPO, which will be targeted toward emergency departments for physicians to assess patients presenting with chest pain, detects levels of myeloperoxidase (MPO), an enzyme found in white blood cells. The test is designed to determine whether a patient is in danger of experiencing a heart attack within a 30-day to six-month timeframe.
The diagnostic technology is being commercialized by PrognostiX (Cleveland), a start-up company spawned by The Cleveland Clinic's technology transfer and commercialization arm.
"Receiving FDA approval to market the blood test under the name CardioMPO is a major milestone for the company and The Cleveland Clinic," said Chris Coburn, executive director of CCF Innovations, the technology transfer and commercialization arm for the clinic.
Coburn told Diagnostics & Imaging Week that the FDA approval is "a wonderful achievement," for the clinic. And it validates the work of the technology's developer, Stanley Hazen, MD, PhD, section head of Preventive Cardiology and Cardiac Rehabilitation at the clinic, in collaboration with Marc Penn, PhD, medical director of the Coronary Intensive Care Unit at the clinic, and Marie-Luise Brennan, PhD.
"From the standpoint of the inventor, who's both a clinician and a researcher, in terms of our shop and the institution, [the approval] puts us that much closer to the ultimate realization of the goal" — that is, product marketing.
Coburn said he believes the CardioMPO will be "a stand-alone test" for predictive purposes.
He acknowledged the development of other assays for heart attack biomarkers — such as troponin, myoglobin and C-reactive protein — but used to detect damage to the heart that has already occurred. CardioMPO has the ability to identify "at-risk patients not recognized by current diagnostic laboratory testing," The Cleveland Clinic has said.
"In our view, [CardioMPO] is going to provide to physicians a tool that is not currently available to them," Coburn said.
"There has been a lot of market calibration," he said, for the product, and the technology has been licensed to "other industry players," for predictive uses.
He also said there has been significant discussion with physicians regarding the great need to be able to distinguish between cardiac events and other sources for the chest pain a patient may be experiencing upon arriving at the emergency room. The problem is a serious one for ED physicians, who face potential career setbacks as well as hospital liability if chest pain is misdiagnosed and a patient is sent home only to have a heart attack afterward.
In February, the diagnostics division of Abbott Laboratories (Abbott Park, Illinois) entered a licensing agreement with The Cleveland Clinic for the development of an automated in vitro diagnostic test to detect MPO (D&IW, Feb. 17, 2005). Under the agreement, Abbott obtained non-exclusive rights to the clinic's existing technologies relating to MPO as a risk indicator for cardiovascular disease. Abbott also maintained worldwide rights to commercialize products using the technology.
In October 2003 when The Cleveland Clinic first reported the development, said Hazen, the test's inventor. "We looked at more than 600 sequential patients who came to the emergency room with chest pain. We found that adding MPO testing to current laboratory-based risk assessments increased our ability to predict future cardiac risks over the next 30 days to six months 50% to 95% of the time."
The study included 604 patients who arrived at the emergency room following the onset of chest pain.
Hazen said, "MPO tests, which were originally designed for research purposes only, are not as accurate as what is needed in patient care settings. The CardioMPO blood test developed and marketed by PrognostiX is accurate and reliable in the diagnosis and treatment of patients."
Specifically, according to the NEJM abstract, results demonstrated that initial plasma myeloperoxidase levels predicted the risk of myocardial infarction, even in patients who were negative for troponin T at base line. Troponin is the leading molecular test used in emergency rooms currently, and it is a protein released from heart muscle cells that are dying because deprived of blood flow during a heart attack.
According to the American Heart Association (Dallas), 1.1 million people have heart attacks each year in the U.S. The Centers for Disease Control and Prevention (Atlanta) estimate that 400,000 to 460,000 people in the U.S. die each year of heart attack in the emergency room or before reaching the hospital.