Evaluation and Validation of Diagnostic Tests for Guiding Therapeutic Decisions

¹ Hôpital Necker, Paris, France
² F Hoffmann-La Roche Ltd, Basel, Suisse
³ Afssaps, Saint-Denis, France

Received: 15 October 2008
Accepted: 20 November 2008

Abstract

The term “theranostics” characterizes a particular combination of the coupled use of a drug therapy with a diagnostic test (called “companion diagnostics”). The diagnostic test marks out the technical means used to identify a biomarker which allows for adjusting the use of the new drug.
Theranostics promise a significant step forward for the use of personalized medicine, better tailored for patients in terms of efficacy and tolerance. The development process of theranostics is complex since it requires a proper phasing from development to reimbursement, through a collaborative and controlled approach.
The task force's recommendations should form the basis for reflection and action amongst the different players in the field of the development of theranostics.
All stages of the system meeting heterogeneous and asynchronous rules should be harmonized to allow for simultaneous availability of, and access to the drug and test. Nevertheless, it is necessary to simplify the regulations to enable a better adaptation of theranostics to the speed of innovation.