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FDA Approves Dako Assays as CDx for Genentech's Breast Cancer Treatment

NEW YORK (GenomeWeb News) – Dako announced late on Monday that the US Food and Drug Administration has approved its HercepTest and HER2 FISH pharmDx as companion diagnostics for Genentech's breast cancer drug Perjeta (pertuzumab).

FDA also approved the drug.

Dako's assays will be used to identify patients with HER2-positive metastatic breast cancer who may be eligible for treatment with Perjeta and are available immediately.

"The role of HER2 in diagnosis and clinical decision making continues to evolve with the recent approval of Perjeta, a new targeted biologic therapy for patients with advanced HER2-positive breast cancer," David Hicks, director of surgical pathology at the University of Rochester Medical Center, said in a statement. "It is clear that optimal patient care depends now more than ever on the accurate, reliable, and reproducible assessment of the HER2 status for the full benefit of Perjeta to be derived by the appropriate patient population."

Dako, which is in the process of being acquired by Agilent Technologies for $2.2 billion, and Genentech, a Roche company, announced in late 2011 a partnership to submit Dako's two assays for regulatory approval as companion diagnostics for Perjeta. In addition, the two companies are collaborating on a submission to FDA for the two assays as companion diagnostics for trastuzumab emtansine, an investigational drug candidate for patients with advanced HER2-positive breast cancer.

Dako, based in Denmark, also has similar companion diagnostic deals with Amgen, as well AstraZeneca, and Bristol-Myers Squibb to develop companion diagnostics.

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