Dako wins companion Dx approval for Roche's Kadcyla

FDA OKs test paired with blockbuster-hopeful cancer drug
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Dako's HercepTest identifies patients with HER2-positive breast cancer for Roche's Kadcyla.--Courtesy of Dako

Dako has been on a tear with big-name companion diagnostics partnerships, and its latest one might end up being the most lucrative: The company has received FDA approval for two tests to be paired with Kadcyla, Roche's ($RHHBY) soon-to-explode breast cancer drug.

Kadcyla, née T-DM1, is a recently approved breast cancer treatment that analysts predict will pull in between $2 billion and $5 billion a year. Now, Dako's two assays, HercepTest and HER2 IQFISH pharmDx, are FDA approved to be sold alongside the targeted drug, identifying patients with HER2-positive metastatic breast cancer who would benefit from it.

Dako, a division of Agilent ($A), teamed up with Roche's Genentech last year to develop the tests, submitting them for FDA approval in the fall. Notably, Roche opted against developing the assays in-house, with its multibillion-dollar diagnostics arm, and chose instead to reach out to Dako.

And it's hardly alone in doing so. The Kadcyla pairing is the result of Dako's fourth Big Pharma partnership in a year, as the company has signed on with Pfizer ($PFE), Eli Lilly ($LLY) and Amgen ($AMGN) to develop diagnostics for oncology drugs. 

"At Dako, we focus on advancing cancer diagnostics, because patients' lives depend on it," CEO Lars Holmkvist said in a statement. "Partnering with companies who are also relentless in their commitment to fighting cancer is an important element in achieving this goal."

Agilent snapped up Dako for $2.2 billion last spring, and the company was already a star in the companion diagnostics world, boasting partnerships with AstraZeneca ($AZN), Bristol-Myers Squibb ($BMY) and Quintiles.

- read Dako's announcement

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