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FDA Approves Dako Assays as CDx for Genentech Breast Cancer Drug

Dako today said that the US Food and Drug Administration has approved two assays for use as companion diagnostics for a Genentech drug targeting HER2-positive metastatic breast cancer. FDA simultaneously approved Dako's HercepTest and HER2 IQFISH pharmDx assays and Genentech's drug Kadcyla (ado-trastuzumab emtansine). Kadcyla is for patients with HER2-positive metastatic breast cancer who have been previously treated with Genentech's Herceptin (trastuzumab) and a taxane chemotherapy. Dako, an Agilent company, and Genentech, a Roche company, have been collaborating on the development of companion diagnostics for Genentech's drugs for a few years. In May 2012 the two firms inked a pact to collaborate on the FDA submission of Dako's assays for Kadcyla. A month later the HercepTest and HER2 FISH pharmDx were approved by FDA as companion diagnostics for Genentech's breast cancer drug Perjeta (pertuzumab). In late 2011, FDA gave the thumbs up to Dako's H...

Agilent to Acquire Dako for $2.2 Billion Acquisition is Next Step in Agilent's Growing Role in Clinical Diagnostics

Dako is one of the leading global providers of cancer diagnostics tools. --Acquisition will strategically complement Agilent's research technologies and will accelerate growth in rapidly expanding segments of diagnostic markets. --Significantly increases base of recurring revenues. --All-cash deal is largest in Agilent's history. Expected to be immediately accretive to Agilent earnings on a non-GAAP basis. Agilent Technologies Inc. and EQT, the Sweden-based private equity group, today announced the execution of a definitive agreement for Agilent to acquire Dako, the Denmark-based cancer diagnostic company. The $2.2 billion acquisition (on a debt-free basis) is the largest in Agilent's history. Dako's products are sold in more than 100 countries, and in 2010 its annual revenue was approximately $340 million (USD). The company employs more than 1,000 people, primarily in Denmark, in Carpinteria, Calif., and other parts of the world. The acquisition is...