Cleveland HeartLab announced its newly launched Universal MPO (myeloperoxidase) test has received CE marking in Europe and has been certified to the standards and requirements of both ISO 13485 and the Canadian Medical Device Conformity Assessment System (CMDCAS). These benchmarks achieved by CHL will dramatically increase access to MPO cardiovascular disease testing and benefit patients with cardiovascular disease (CVD) risk around the globe.
The new Universal MPO assay is a TIA (turbidimetric immunoassay) that provides high quality and automated results on various laboratory chemistry analyzers. For the first time, this allows international laboratories the ability to offer this state-of-the-art technology within their current laboratory systems making it easier to adopt this valuable technology in broader markets.
A recent publication in the Journal of Medical Economics demonstrated the use of MPO testing along side of LP-PLA2 and hsCRP and in combination with standard lipid testing could reduce heart attacks and strokes by approximately 10% compared to traditional cholesterol testing alone, not only saving lives but also hundreds of millions of healthcare dollars. MPO within the bloodstream is a vascular-specific marker for vulnerable plaque formation.
Vulnerable plaque occurs when arterial narrowing is exacerbated by inflammation, the body’s natural response to injury. In 2001, researchers at the Cleveland Clinic were the first to document the association between MPO levels and risk of coronary artery disease. MPO has been licensed exclusively from the Cleveland Clinic to Cleveland HeartLab and there are now over 30 issued and pending patents globally.
“The new availability to measure MPO in Europe will catalyze further research into cardiovascular health,” said Stephan Baldus, MD, Professor of Medicine at The Heart Center of the University Hospital of Cologne. “CVD is a global health threat of enormous concern and MPO testing can have a meaningful positive effect.”
Dr. Baldus has published several studies on the role of inflammation in heart disease and the potential value of MPO in diagnosing arterial inflammation. A recent study showed CVD is the single greatest cause of death among Europeans, killing more people each year than any other disease. In some regions of Europe, CVD kills twice as many people as cancer.
“Expanding the use of MPO could not come at a better time,” said Stephen Nicholls, MBBS, PhD, Professor of Cardiology, University of Adelaide and Cardiologist at the Royal Adelaide Hospital. “According to the World Health Organization, CVD is the leading cause of death worldwide, responsible for an estimated 17.5 mil deaths in 2012, or 31% of all fatalities worldwide. As obesity and diabetes are reaching epidemic levels in developing regions of the world, CVD has become a global crisis with dramatic increases in China, India and Latin America.” Dr. Nicholls is the lead author of the IVUS study, Myeloperoxidase levels predict accelerated progression of coronary atherosclerosis in diabetic patients: insights from intravascular ultrasound.
“As a demonstration of our continuous commitment to innovation, quality and patient care, CHL achieved ISO 13485 and CMDCAS certifications after completing a rigorous audit of our quality and management system,” said Jake Orville, CEO of CHL. “Both certifications set global standards for quality. Achieving both of these certifications, as well as launching the next generation CE-mark Universal MPO assay is another example of our ability to bring high value advanced diagnostics to market. Achieving ISO and CMDCAS certification not only demonstrates that our organization adheres to the highest standards of quality and excellence, it also allows us to expand access into global markets—another vital distinction for CHL.”
The International Organization of Standardization (ISO) 13485 is the globally accepted standard for the implementation of comprehensive quality management systems applied to all facets of the medical technology industry, including the development, manufacture, quality control and sale of medical devices.
According to the U.S. Department. of Health and Human Services, Americans suffer 1.5 mil heart attacks and strokes each year. CVD—including heart disease and stroke—is the leading cause of death in the U.S. Every day, 2,200 people die from CVD—that’s nearly 800,000 Americans each year, or 1 in every 3 deaths. According to the American Heart Association, half of those who suffer heart attacks and strokes have “normal” cholesterol levels, so new tools are desperately needed to improve our ability to assess CVD risk in patients whose risk is not revealed by cholesterol testing alone. The U.S. spends approximately $4 tril on healthcare annually, one-sixth of which is spent treating CVD, according to the Centers for Disease Control and Prevention.