LAUSR

The world of laboratory medicine is in a state of flux. The publication of the NHS Long Term Plan, for example, promulgates that by 2021, newly formed ‘Pathology Networks’ across England will enable improved test turnaround times, increased access to more complex tests and better career opportunities for healthcare scientists at less overall cost. Appropriately, in 2018, seven Genomic Laboratory Hubs were established with mobilization towards consolidated provision. Such ambitions will undoubtedly necessitate significant transformation in the future provision of pathology services. This, in hand with the promise of the 100,000 Genomes Project, and cautious optimism regards the burgeoning field of precision medicine, may herald a paradigm shift in laboratory diagnostics. At the EU level, May 2017 witnessed publication of the In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746. The IVDR replaces the incumbent In Vitro Diagnostic Medical Device Directive 98/79/EC and will become fully applicable in 2022, allowing a fiveyear transition period to the new Regulations for EU Member States. Notably, the IVDR has expanded the clinical evidence requirements for new In Vitro Diagnostic (IVD) to include evidence of scientific validity (the association of an analyte with a clinical condition or a physiological state), analytical performance (the ability of a device to correctly detect or measure a particular analyte) and clinical performance (the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user). These should support the intended use of the IVD product, for assessment of expected clinical benefits and potential harm. The World Health Organization (WHO) recently published the Model List of Essential In Vitro Diagnostics (EDL) in recognition that IVDs are an essential component to advance universal health coverage, address health emergencies and promote healthier populations. The EDL is also intended to complement the WHO Model List of Essential Medicines and enhance their rational and safe use. The EDL will be reviewed annually through a WHO call for applications to add IVD tests, with applicants required to provide information on clinical accuracy or impact of the proposed IVD. One would foresee that these organizational and regulatory developments may have significant ramifications for laboratory medicine, not least in terms of biomarker evaluation, translation and adoption of medical tests for clinical practice. This happens on the backdrop of an apparent translational inertia within the biomarker development pipeline, where few molecular or ‘omics’-based tests have evidenced progress towards clinical application, despite significant research investment. The problems concerning study design and reporting within the biomarker research pipeline are numerous and well documented, and concerns highlighting questionable analytical performance of commercial