Dako and Genentech to seek approval of cancer diagnostic tests

Dako has announced a new alliance with Genentech that will see the firms jointly seeking regulatory clearance for a companion diagnostic testing method for a new breast cancer drug.

The companies will be applying to the US Food and Drug Administration (FDA) for approval of the HercepTest and HER2 FISH pharmDx devices as companion diagnostics for the investigational drug candidate pertuzumab.

It is thought that these testing methods can help to offer insight into which patients would benefit most from treatment using pertuzumab, a therapy specified for advanced HER2-positive breast cancer.

This comes as part of a wider programme by Dako to work alongside pharmaceutical companies to expand its companion diagnostic assay range.

Lars Holmkvist, chief executive officer of Dako, said: "I strongly believe collaborating with Genentech on the joint FDA approval for companion diagnostics for pertuzumab will benefit many breast cancer patients in the future."

This comes after the firm allied with Bristol-Myers Squibb last month to develop a new range of pharmacodiagnostic tests.