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Methods of value demonstration in IVD technology

This article was originally published in Clinica

Executive Summary

As evidentiary requirements in the in vitro diagnostic (IVD) market increase, manufacturers are under greater pressure to demonstrate the value of their products as soon as they enter the market in order to ensure routine coverage by healthcare insurers. "Value" in this case has a broad definition, covering both clinical and economic applications, with individual requirements often hinging on a combination of product price, market size and clinical impact. Thus far, no specific prescription for value seems applicable to all IVD technologies, making data development both a guessing game and a financial risk for manufacturers.

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