In vitro diagnostics in the development and use of cardiovascular medicines.

The list of potential cardiovascular biomarkers has expanded dramatically in recent years; however, the number of regulatory agency-approved diagnostic tests that guide treatment has been relatively unchanged compared with this growth in the discovery of putative biomarkers. Surrogate biochemical endpoints such as LDL and HDL are included in the current guidelines of various regulatory agencies for the management of cardiovascular diseases, as a result of many years of research. Inclusion of tests for these markers, as well as any future tests, in treatment guidelines requires data obtained from large-scale clinical trials comparing these endpoints with 'hard' clinical endpoints, such as morbidity and mortality. Consequently, current guidelines are limited to conventional in vitro tests and incorporate few novel tests for guiding or modifying treatment. Despite the failure to include newer in vitro tests in cardiovascular treatment and prevention paradigms, ongoing biomarker discovery and assay optimization has provided many improvements in drug discovery and development, and has afforded opportunities for the optimized medical treatment of patients with cardiovascular disease.