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Dako, Genentech Partner on Regulatory Submission of CDx for Second Breast Cancer Drug

NEW YORK (GenomeWeb News) – Dako has signed an agreement with Genentech to partner on the regulatory submission of companion diagnostic tests for a breast cancer drug.

Under the agreement announced today, the companies will collaborate on the US Food and Drug Administration submission of Dako's HercepTest and HER2 FISH pharmDx as companion diagnostics for Genentech's trastuzumab emtansine, an investigational drug candidate for patients with advanced HER2-positive breast cancer.

The tests are for identifying patients who may be eligible for treatment with Genentech's drug.

Dako and Roche business Genentech are also collaborating on the regulatory submission of Dako's HercepTest and HER2 FISH pharmDx as a companion diagnostic for Genentech's pertuzumab, an investigational drug candidate for breast cancer.

In late 2010, the FDA cleared Dako's two tests to expand their intended use to include patients with metastatic gastric or gastroesophageal junction adenocarcinoma. The tests are used to help guide treatment of patients for whom Genentech's Herceptin (trastuzumab) is being considered.

The deal is also the third drug-firm partnership announced by Dako since the start of the year to develop companion diagnostics. Earlier, it announced two deals with Amgen directed at undisclosed cancer drug candidates.

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