Where Is the Value of Laboratory Medicine and How Do You Unlock It?

Abstract

Abstract Background The innovation pathway by which a newly discovered biomarker is developed into a medical test and used in routine clinical practice comprises a number of different processes split between 2 phases. The first follows on from biomarker discovery and involves the development of a robust analytical method, the accumulation of evidence to show its clinical and cost-effectiveness, and then adoption into clinical pathways. The second phase is one of implementation and sustainability, with active performance management to ensure that the test continues to deliver the benefits promised at the time of its adoption. Content To date there has been much more emphasis on the first phase of discovery and accumulation of evidence to demonstrate effectiveness. Insufficient attention has been paid to the second phase of translating that evidence into routine practice, with little real-world evidence to demonstrate the benefits to all of the stakeholders involved in delivering and receiving care. Changes in healthcare that include a move away from activity-based costing to a more value-based approach require more attention be paid to what happens after a test is adopted, including an understanding of the clinical pathway, the stakeholders within that pathway, and the benefits and “disbenefits” that accrue to these stakeholders. Summary The value proposition provides a guide for successful implementation of a test. Although it can address both adoption and implementation, it highlights that the requirements for test implementation are quite different to those of adoption, with an emphasis on real-world evidence and outcomes.