Companion diagnostic IVD kit or lab developed test?

Speaker: Peter Keeling, CEO, Diaceutics.

Companion diagnostic IVD kit or lab developed test? Why Europe needs a different entry strategy for pharmaceutical companies hoping to create universal access to companion diagnostics.

With the parallel approval of ALK testing and Xalkori and BRAF testing and Zelboraf in the US, the FDA is clearly signaling its preference for regulated companion diagnostics.

However since greater than 60% of all testing in Europe is conducted via laboratory developed tests and up to 40% of oncology Labs in Europe have never purchased an IVD kit for molecular testing, Pharma needs to consider a different strategy in Europe if it seeks to encourage widespread testing.

Results from a Pan EU Delphi study on Laboratory attitudes to companion diagnostics will be presented and unique insights and controversial recommendations for the creation of an "efficient" diagnostic market to support targeted therapy prescribing will be discussed.