Report Confirms Multimarker Approach as Definitive Tool

Cleveland Heartlab Press Releases

Report Confirms Multimarker Approach as Definitive Tool to Identify and Help Diminish Cardiovascular Risk

–Cleveland HeartLab and MDVIP Co-Authored, Peer-Reviewed Article Analyzing Biomarker Test Data from 95,000 Patients–

(July 18, 2013, Boca Raton, FL & Cleveland, OH) – A just-published report, co-authored by the medical leadership of Cleveland HeartLab (CHL) and MDVIP for the peer-reviewed journal Future Cardiology (July 2013), clearly demonstrates the utility of a multimarker approach to determine cardiovascular risk. The data that was reviewed came from over 95,000 MDVIP patients who received an annual wellness panel that contains multiple biomarkers that go beyond basic lipid tests. As part of a comprehensive approach to wellness and prevention, MDVIP-affiliated physicians use this advanced testing to drive early detection and highly personalized care.

The new report analyzing one of the largest patient screening data sets validates a significant difference between a multimarker approach, including CHL’s inflammation testing, versus conventional lipid-only testing. The MDVIP biomarker wellness panel proved to be a highly effective tool in risk prediction. This distinction is vitally important due to the fact that at least 50% of patients who present with acute myocardial infarction (heart attack) have “normal” or treated cholesterol levels.

“The report is significant validation for CHL’s multimarker approach to identify arterial inflammation that has been shown to be predictive of risk for future heart attack and stroke, even in seemingly healthy patients,” said Marc Penn, MD, PhD, FACC, Chief Medical Officer of CHL and Director of Cardiovascular Research, Summa Health System, Akron, OH. “We have a strong commitment to detect and diminish cardiovascular risk and further long-term health and well-being through the development of novel tests to define cardiovascular risk.”

Significant data presented in the report:

  • Based on a lipid-only wellness panel, approximately 30% of patients presented as being at risk.
  • Based on a multimarker panel, 70% of patients were found to be at risk, with 40% having more than one marker positive.

“Not only are we identifying more patients at risk in our preventive care model, but we are more specifically determining where those patients are on the spectrum of risk, which has a great impact on clinical care,” added Andrea Klemes, DO, Medical Director of MDVIP, the premier network of affiliated primary care physicians practicing wellness and prevention. “Our physicians are confident that with this approach they are preventing the onset of cardiovascular disease and helping to keep inflammation at bay.”

Additionally, the report went on to compare findings reflected in data on higher acuity markers: Lp-PLA2 and MPO. Independent studies have demonstrated that each of these biomarkers indicates the presence of increased risk for cardiovascular events based on increased risk for plaque vulnerability.

In the additional set, results of Lp-PLA2 and MPO testing of 2,700 patients from executive health and preventive cardiology clinics highlighted the importance of a multimarker strategy to identify risk. The biomarkers analyzed in the report show that approximately 6% of the patients had increased risk (due to an elevated MPO), while 5% of the patients were at risk (due to an elevated Lp-PLA2). However, in this asymptomatic outpatient population only 0.2% showed elevated levels for both markers.

“As we note in the paper, independent of whether these inflammatory pathways are involved in disease progression, by understanding the physiology these markers reflect when elevated, we can garner a deeper understanding of individual patient risk for cardiovascular events and treatment effects through a multimarker approach without redundancy in the case of MPO and Lp-PLA2,” said Dr. Penn. “If one were to take a single marker approach, it would suggest that one is comfortable with assessing only one side of the coin or only half of the patient’s potential for risk,” stated Dr. Penn.

The multimarker screening panel for the report in the Future Cardiology article, “Multimarker Approach for Identifying and Documenting Mitigation of Cardiovascular Risk,” was developed in leadership collaboration between MDVIP and CHL for 95,144 patients who underwent wellness panel screenings performed by their MDVIP physicians in 2011. All analyses were performed on de-identified data, without regard for past medical history, physical examination or medication profile. Analysis was completed at the Cleveland HeartLab, Cleveland, OH.

Highlights – Executive Summary of CHL / MDVIP Report from Future Cardiology (July 2013)


  • Early detection of disease allows the potential for prevention or morbidity and mortality.
  • Success in modulating risk from one pathway often increases the need and utility of risk stratification by other pathways.

Multimarker screening for wellness:

  • Molecular mechanisms of ischemic cardiovascular events are being better defined.
  • Beyond lipids, inflammation has a key role in inducing plaque rupture.
  • No single marker fully defines a patients’ cardiovascular risk profile.

Multimarker approach to assess acuity of risk:

  • A panel of multiple markers that are not synergistic or additive increases costs unnecessarily without improving risk prediction.
  • Understanding the physiology reflected by a given biomarker allows multiple markers to be used in parallel to more fully define risk without redundancy.

Multimarker testing for cardiovascular risk:

  • Using a multimarker approach to identify patients prior to a clinical event has the potential to decrease costs if the event can be prevented.
  • A multimarker approach has the potential to risk stratify and define risk in self-insured populations to a greater extent than is now possible.

About Cleveland HeartLab:

Cleveland HeartLab Inc. is an advanced clinical laboratory and cardiovascular disease management company. Established in 2009, CHL offers an array of proprietary testing and analysis focused on the identification and reduction of cardiovascular inflammation. The company operates a CLIA-certified and CAP-accredited national clinical laboratory. CHL has developed prognostic tests, based on unique molecular biomarkers, which are used by thousands of medical practitioners for better prediction of risk beyond standard risk factors such as cholesterol testing.  CHL also has an innovative research and development group that is tasked with the discovery and commercial development of next-generation cardiovascular biomarkers for utilization through the company’s clinical laboratory. This valuable research-enabled pipeline of tests and testing services is part of CHL’s novel intellectual property portfolio that targets large under-served markets. For more information, visit us at

About MDVIP, Inc:

MDVIP, Inc. is the national leader in affordable personalized healthcare.  With prevention at the center of its program, MDVIP has proven that its carefully chosen affiliated physicians provide exceptional care and achieve exceptional outcomes.  These results include lower hospitalization rates which yield significant cost savings to patients, employers and the healthcare system.  MDVIP-affiliated physicians limit their practices to no more than 600 patients in order to provide a customized wellness and preventive care program.  There are currently over 650 MDVIP-affiliated physicians serving over 200,000 patients throughout the country.  MDVIP, Inc. was founded in 2000 and is headquartered in Boca Raton, Florida.  For more information, visit, or

The abstract and web exclusive, “Multimarker Approach for Identifying and Documenting Mitigation of Cardiovascular Risk” authored by Marc S. Penn and Andrea Klemes, appears in Future Cardiology, July 2013, Vol. 9, No 4.

MDVIP Medical Director Dr. Andrea Klemes and CHL Chief Medical Officer Dr. Marc Penn are available for interviews. 

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Lisa Szabo
Cleveland HeartLab

Nancy Udell

Maryann Palumbo