Dako gains FDA blessing for breast cancer antibody Dx agent

Dako's push to grow its molecular diagnostics business continues apace. The Danish company gained FDA clearance to start selling a new monoclonal antibody for breast cancer diagnostics.

The antibody is known formally by the super-long name FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor alpha, Clone EP1, or just Clone EP1 for short. And like plenty of diagnostics and devices, it was sold in Europe for quite a while before reaching the U.S. market. Epitomics developed Clone EP1, and Dako, a diagnostic tools company, is selling it as part of a 2011 collaboration deal.

Its use helps determine the status of estrogen receptors in breast cancer. Estrogen, progesterone or both can fuel tumor growth. And Clone EP1 is used to gauge the presence of nuclear estrogen receptor without cytoplasmic staining, which helps closely manage anti-hormonal breast cancer therapy as part of the process.

The launch is yet another example of Dako's advance in light of Agilent Technology's $2.2 billion purchase of the company in May 2012. Since then, Dako has plowed ahead, inking a number of companion diagnostic partnerships with companies including Roche ($RHHBY), Eli Lilly ($LLY) and Pfizer ($PFE), and continued deals with companies such as Quintiles, Bristol-Myers Squibb ($BMY) and AstraZeneca ($AZN).

- read the release

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