The scientific literature abounds with the reports of new hormones and related biomarkers and their preliminary application to clinical situations. A small proportion of such discoveries translate into service delivery because initial studies are not substantiated and/or the economics of commercial method development are not favourable. There is a spectrum of endocrine biomarker assay provision from research assay, to specialised service assay to routine service assay. In general assay quality improves across this spectrum.
The introduction of new methods for measuring endocrine biomarkers of established clinical value is driven by the desire to improve specificity and other quality indices. The introduction of tandem mass spectrometry for the measurement of steroid hormones and catecholamines illustrate this trend.
Anti-mullerian hormone and adiponectin are endocrine biomarkers that have recently become established in clinical practice. Anti-thyroid peroxidase is an old endocrine biomarker that has had a new lease of life arising from clinical discovery.
Tests that target the molecular basis of endocrine disease are numerous and useful in understanding the aetiology of the disorder but they have tended to be of limited value in routine clinical practice. In the future such tests may be used in combination with biomarkers and clinical parameters in algorithms to predict the risk of polygenic endocrine disorders or to optimise the individual response to pharmaceutical treatment.
Evidence-based clinical guidelines are an established part of endocrinology. Such guidelines usually include recommendations on the harmonization of practice through the rational use of routine and specialist biomarker tests. Recent examples of evidence-based guidelines include the investigation of Cushings syndrome and primary hyperaldosteronism.
The UK has a reputation for being slow to introduce new tests into service. Initiatives are under way to try to speed up this process through the proposed introduction of a national programme of diagnostic test evaluation.