Cleveland HeartLab offers innovative, scientifically proven, and medically relevant biomarkers that are predictive of cardiovascular risk. We offer inflammatory and other advanced biomarker testing that practitioners from across North America, Europe and Asia use in the management and prevention of heart disease. Our novel biomarker technologies are offered through our CAP-accredited and CLIA-certified clinical reference laboratory. We also run a research and development laboratory where next-generation cardiovascular disease biomarkers are being developed for use through our clinical laboratory. This valuable pipeline of tests is part of an exclusive intellectual property portfolio that targets large, under-addressed markets. Additionally, Cleveland Heartlab is ISO 13485 certified and the exclusive providers of Universal CardioMPO™ kits.
Note: At the discretion of the Medical Director, Cleveland HeartLab may solicit other clinical laboratories to perform testing on our behalf. Under these circumstances, the performing lab may be indicated on the final report.
Aid clinicians in identifying risk and reducing cardiovascular events.
To be the premier cardiovascular testing provider.
- Evidence-based science and clinical testing
- Superior quality
- Solutions-oriented attitude
- Integrity in all we do
In support of our mission we have three key areas of focus:
We maintain a robust research and development program that partners with leading academic and medical institutions to bring unique biomarker technologies to market. Our first proprietary biomarker – Myeloperoxidase (MPO) – was the result of research and development at the Cleveland Clinic, and received 510(k) clearance from the FDA within 13 months of discovery. We have an expansive, global intellectual property portfolio that includes over 50 issued and pending patents. We consistently bring new, novel biomarkers to the market and maintain an active pipeline in development.
Cleveland HeartLab is an established, premier inflammation testing laboratory with the most experience in the field. Our scientifically-proven, peer-reviewed multi-marker approach of adding inflammation-specific tests to traditional lipid testing provides additional insight into an individual’s cardiovascular risk. In addition, our approach measures risk across a spectrum, allowing for long-mid-, and near-term assessment. This enables healthcare providers to identify ‘hidden risk’ and treat more aggressively when appropriate. Our testing is supported by over 100 peer-reviewed articles. Most recently, a seminal, peer-reviewed study published in the Journal of Medical Economics shows Cleveland HeartLab’s inflammation testing could reduce the average heart attack and stroke rate by approximately 10%. Over five years, this reduction would avert $187 million in healthcare costs for cardiovascular disease – the number one killer of men and women in the U.S.
We are committed to educating healthcare providers and patients on the advancements in identifying cardiovascular risk. We organize signature CME-accredited events and local medical forums which attract hundreds of medical professionals from across the United States. Our clinical Education Team provides access to peer-to-peer support, the latest articles on the clinical utility of inflammatory biomarkers and individual case management support. We developed and provide a CME website for healthcare professionals (chlcme.com) and a website designed for patients (knowyourrisk.com).
Our team is committed to providing clinical education to our customers and the community. Key members include:
Marc S. Penn, MD, PhD, FACC – Chief Medical Officer
Deborah H. Sun, PhD, DABCC, FACB – Vice President of Laboratory Operations
Lynn Cofer-Chase, MSN, CLS, FAHA, FPCNA, FNLA – Clinical Lipid Specialist/Clinical Education Manager
David DeSantis, PhD – Manager of Educational Affairs
These individuals provide consultation to our customers including information on inflammation biomarkers, latest recommendations on Standard and Advanced Lipids, and individual case management.