Companion diagnostic tests: breakthroughs and blisters

Abstract

Tumour profiling for the purpose of targeted therapies and personalised medicine has seen a rapid rise in the availability of companion diagnostics. Companion diagnostics can be defined as ‘an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product’ (FDA website http://www.fda.gov). Clinical diagnostic laboratories in Australia are now faced with decisions on whether to develop an in-house in vitro diagnostic device (IVD) or implement where available a companion diagnostic. This choice can be difficult, particularly when a laboratory may have already invested much time and effort in developing, validating and gaining accreditation for an in-house IVD. Confounding factors in this decision making process can be clinical trials with predicated companion diagnostics, and limited evidence for efficacy of the companion diagnostic or an in-house IVD. Issues related to the role of companion diagnostics in the Australian clinical laboratory will be reviewed and, in particular, the role of the laboratory director in choosing an appropriate assay will be discussed.