Point-of-care diagnostics: will the hurdles be overcome this time?

Abstract

Point-of-care diagnostics have been proposed as the latest development in clinical diagnostics several times in the last 30 years; however, they have not yet fully developed into a business sector to match the projections. This perspective examines the reasons for past failures and the failure of technology to meet user needs. Advances have taken place in the last few years that effectively remove technology as a barrier to the development of point-of-care testing. Even regulatory issues regarding how products are developed and claims supported have been absorbed, understood and now accepted. The emphasis here is on the possible favorable aspects that are novel this time around. These changes have arisen as a result of the situation with global healthcare economics and the pressure from patients to be treated more like customers. The final hurdles relate to the conflict between diagnosis with the patient present and treated as soon as the point-of-care result is available and the entrenched positions of the central laboratory, the suppliers and their established distribution chains, and the way in which healthcare budgets are allocated. The ultimate hurdle that encapsulates all of these issues is reimbursement, which is the final barrier to a significant point-of-care diagnostics market--without reimbursement there will be no market.