Dako, a manufacturer of cancer diagnostics solutions, has received approval from the US Food and Drug Administration to market HercepTest and Her2 Fish pharmDx kit as co diagnostics for pertuzumab (Perjeta), a Genentech cancer drug.
Dako's HercepTest and HER2 FISH pharmDx Kit are used to recognise cancer patients with HER2-positive metastatic breast cancer, who may be eligible for Perjeta treatment.
Pertuzumab, which received approval from FDA, will be marketed under the name of Perjeta.
Dako CEO Lars Holmkvist said,"Dako supports laboratories and doctors in the process of identifying HER2-positive breast cancer and this way we make vital treatment available to patients battling this aggressive disease."
Source:
http://laboratoryinstrumentation.pharmaceutical-business-review.com/news/fda-clears-dako-herceptest-and-her2-fish-pharmdx-kit-120612