Benchmarks for the Assessment of Novel Cardiovascular Biomarkers

Abstract

The investigation of novel circulating serum and plasma biomarkers in patients with cardiovascular disease has been accelerating at a remarkable pace. For example, a Medline search that uses the terms “biomarkers” and “acute coronary syndromes” (ACS) reveals an approximate tripling in the number of published reports during the 2-year interval from 2003 to 2004 compared with the period from 2001 to 2002, and this number more than doubled from 2005 to 2006. Although this expanding body of research has established firm evidence for the value of biomarkers, such as for diagnosis and risk assessment among patients with suspected ACS,1 it has also deluged the clinical and research communities with candidate biomarkers, very few of which are likely to survive the test of time as useful clinical tools.2,3 It is thus increasingly important for researchers, manufacturers, regulators, and clinicians to critically appraise the value of new biomarkers as they emerge as candidates for further investigation and possible clinical application. The superb report by Wollert and colleagues4 in the present issue of Circulation on growth differentiation factor-15 (GDF-15) as a biomarker for prognostic assessment in ACS provides an opportunity to outline a basic set of benchmarks against which new markers can be evaluated. Article p 962 Assessment of the clinical potential of a novel biomarker5 may be structured around 3 fundamental questions (Figure): (1) Can the clinician measure it? (2) Does it add new information? (3) Does it help the clinician to manage patients? A, Criteria for assessment of novel cardiovascular biomarkers for clinical use. Statements in bold font are given the highest priority. B, Clinical applications of cardiovascular biomarkers. To be clinically useful, analytical methods must be available that allow reliable measurement, optimally with capability for high throughput tests, prompt turnaround time, and reasonable cost. Evaluation of …