FDA Approves Two Dako A/S (Acquired by Agilent Technologies, Inc.) Assays as Companion Diagnostics for Genentech's Breast Cancer Medicine
Published: Mar 05, 2013
GLOSTRUP, DENMARK--(Marketwire - March 05, 2013) - Dako, an Agilent Technologies Company and worldwide provider of cancer diagnostics, announced today it has received approval from the U.S. Food and Drug Administration 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.
Today's 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.
About Dako - An Agilent Technologies Company
Dako, based in Denmark, is a global leader in tissue-based cancer diagnostics. Hospital and research laboratories worldwide use Dako's reagents, instruments, software and expertise to make accurate diagnoses and determine the most effective treatment for cancer patients. Dako, with 1,200 employees, operates in more than 100 countries. Dako became part of Agilent Technologies on June 21, 2012. Information about Dako is available at www.dako.com.
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is the world's premier measurement company and a technology leader in chemical analysis, life sciences, diagnostics, electronics and communications. The company's 20,500 employees serve customers in more than 100 countries. Agilent had revenues of $6.9 billion in fiscal 2012. Information about Agilent is available at www.agilent.com.
Maia Fredtoft Sochting
Dako Denmark A/S
Tel. +45 25 46 10 83