Point-of-care diagnostics: an advancing sector with nontechnical issues

Abstract

The particular reasons for the relative lack in development of point-of-care (PoC) diagnostics in a business context were discussed in our sister journal, Expert Review of Medical Devices, over 2 years ago. At that time, it could be seen that the concept of PoC testing was being revisited for at least the fifth time in the last 20 years. There had been important advances in technology but, with changes in global healthcare structures and funding, the overall in vitro diagnostics sector has had sluggish growth. Only molecular diagnostics and PoC testing are growing strongly. PoC testing is now a quarter of the total global in vitro diagnostics market, but largely due to use in diabetes monitoring. An increased focus on areas other than glucose self-testing has created a disturbance in the market. An implementation issue from this disturbance is that of control between central laboratories and the proposed sites for PoC testing. Evidence is presented to show that the first step is likely to be increased use in clinics and outpatient facilities closely linked with the laboratory. The aim will be to control the quality of the test, maintenance of equipment and provide support for the clinician in interpretation. The major problem for effective PoC implementation will be the significant changes to patient pathways that are required. The changes will benefit the patient and clinical outcomes but will require healthcare professionals to change their work patterns. This will be an uphill task!

Keywords::

• diagnostics
• economics
• healthcare
• in vitro diagnostics
• multiplex assays
• point-of-care
• regulatory
• reimbursement
• segmentation
• technology

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.