After publishing The Diagnostics Reimbursement Compass: A 90-Minute Guide to Define, Demonstrate and Capture Diagnostics Value Confidently we have also created some short “explainer” videos.
Check out: #2 – What makes diagnostics solutions special?
The intended use of a test defines its purpose and has major implications on risk classification, regulatory, clinical data requirements and commercialization. It is important to differentiate between manufacturer-developed “commercial kits” or laboratory-developed tests (LDTs) and/or procedures.
The test function and where it plays a role in the patient journey—be it a screening, diagnosis, prognosis, or monitoring tool determines its value proposition.
A broad variety of scientific methods can be used to analyse biological samples in large, point of care or novel digital diagnostic devices by laboratory experts, medical professionals or by patients themselves to generate test results.
Test results can support decision-making in inpatient, outpatient, specialist, general practitioner and/or in-home settings.