FDA Approves Two Dako Assays as Companion Diagnostics for Genentech’s New Breast Cancer Medicine Kadcyla

Dako, an Agilent Technologies Company and worldwide provider of cancer diagnostics, announced it has received approval from the U.S. Food and Drug Administration (FDA) for the addition of Kadcyla in the labeling of two Dako companion diagnostic assays.

Kadcyla (ado-trastuzumab emtansine) is Genentech’s new medicine for patients with HER2-positive metastatic breast cancer who have received prior treatment with Genentech’s cancer medicine Herceptin (trastuzumab) and a taxane chemotherapy.

The two assays are Dako’s HercepTest and HER2 IQFISH pharmDx. The announcement is the result of a collaboration between Dako and Genentech, a member of the Roche Group. The collaboration was initiated in early 2012, and later the same year Dako submitted applications to the FDA requesting approval of the two Dako assays as companion diagnostics for Genentech’s drug candidate for patients with HER2-positive metastatic breast cancer.

Genentech’s Kadcyla, an antibody-drug conjugate, and Dako’s HercepTest and HER2 IQFISH pharmDx have received simultaneous approvals from the FDA. Dako’s HercepTest and HER2 IQFISH pharmDx will serve as diagnostic tools to identify cancer patients with HER2-positive metastatic breast cancer who may be eligible for Kadcyla treatment.

“At Dako, we focus on advancing cancer diagnostics, because patients’ lives depend on it,” said Lars Holmkvist, CEO of Dako and senior vice president, Agilent. “Partnering with companies who are also relentless in their commitment to fighting cancer is an important element in achieving this goal. Today’s FDA approval is the result of excellent collaboration between Dako and Genentech.”

Dako’s ongoing strategy is to combine its strength in developing companion diagnostics with its proven ability to partner with pharmaceutical companies to increase the number of companion diagnostic assays and ultimately improve personalized medicine.