Skip to main content
Premium Trial:

Request an Annual Quote

Dako, Genentech Partner on Companion Dx FDA Submission for Pertuzumab

NEW YORK (GenomeWeb News) – Cancer diagnostics firm Dako said today it is collaborating with Genentech on the regulatory submission in the US of two Dako tests as companion diagnostics for Genentech's investigational drug candidate for breast cancer.

The companies will partner on submitting Dako's HercepTest and Her2 FISH pharmDx to the US Food and Drug Administration as companion diagnostics for Genentech's pertuzumab as a treatment for patients with advanced HER2-positive breast cancer.

Terms of the deal were not disclosed.

"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," Lars Holmkvist, CEO of Dako, said in a statement.

A year ago Dako's two tests were cleared by FDA as a tool to help guide treatment of patients with Genentech's Herceptin (trastuzumab) in combination with chemotherapy for HER2-positive metastatic cancer of the stomach or gastroesophageal junction in men and women who have not received prior medicines for their metastatic disease.