eBook

Molecular Diagnostics Clinical Utility Strategy: A Six-Part Framework

September 8, 2014

Payers and technology assessments currently evaluate diagnostic tests in terms of three categories of information. These are “analytical validity” (the performance features of the test), “clinical validity” (the correlation between the test result and clinical conditions), and “clinical utility” (the impact of test deployment on healthcare outcomes.)

Unfortunately, this framework has proved too general to facilitate clear communications between innovators and payers, and may often result in unhelpful conclusions (“the test doesn’t have enough clinical utility, and needs more clinical utility.”)

Frueh and Quinn propose a six-part framework, based on six key questions, that will help frame and assess the importance of new diagnostic tests. The framework is applicable to molecular diagnostics, advanced imaging, and other types of diagnostic tests.

Download the full content of Molecular Diagnostics Clinical Utility Strategy: A Six-Part Framework (.pdf)

Access the original publication at the peer-reviewed journal Expert Review in Molecular Diagnostics.