Dako and Amgen expand collaboration

“Instant quality (IQ) FISH is a new proprietary technology developed by Dako which we introduced in 2012,” says Henrik Winther, vice president of global CDx business development for Agilent Technologies. “It allows a FISH biomarker assessment test to be performed in just 3.5 hours as compared to the usual 17-hour test turnaround time and without compromising on the quality of the test results.”

“We are pleased to continue our work with Amgen, particularly within the molecular arena,” said Jacob Thaysen, vice president and general manager for Agilent’s diagnostics and genomics business. “We are excited to expand this collaboration into even more projects.”

In a statement, Dako claims that the cutting-edge IQFISH hybridization buffer enables pathology labs—for the first time—to run DNA-based hybridization assays quickly, with distinct and higher fluorescent signal intensity compared to traditional FISH assays. This ability represents a major advance for pathologists, oncologists and ultimately patients.

High quality and fast turnaround time is of major importance within molecular diagnostic testing, Winther notes. “The high quality of the technology enables laboratories worldwide to perform safe, reliable and robust testing of cancer biomarker expression and the extreme fast turnaround time allows—in this case—the pathologists to report their results to the oncologists within the same day, meaning patients can begin cancer treatment sooner than ever,” Winther states.

The new technology is based on the development of a different and innovative hybridization buffer, which allows for the very fast turnaround time, Winther explains. “Apart from speed, the new buffer system also avoids the use of toxic formamide, which is used in the traditional hybridization buffers. The IQFISH hybridization buffer is hence environmentally friendly and does not require a fume hood during use, allowing for a more elegant workflow,” he notes.

Addressing the ongoing development of Dako’s relationship with Amgen, Winther notes that “In our companion diagnostic projects with Amgen, our assays (tests) are developed to detect the biomarker expression either at the genetic or at the protein level or at both levels depending on the correlation or lack of same between the biomarker expression and the patient outcome data. At Dako we use ISH (including IQFISH) system solutions to detect DNA and IHC (immunohistochemistry) system solutions to detect protein, and hence all our IHC and ISH system solutions are used in the collaboration with Amgen.”

Companion diagnostics are becoming increasingly important in treating disease. They provide a way to both improve patient care and reduce healthcare costs by matching specific therapies to the individuals most likely to benefit from them, since all patients do not respond in the same way.

Dako has partnered with top-tier pharma companies for the development of companion diagnostics with a record of successful long-term relationships with companies such as Bristol-Myers Squibb and Genentech and, most recently, Eli Lilly, Pfizer and, in an agreement announced earlier this year, with Merck KGaA.

“Our collaboration with Merck KGaA is under a master framework agreement similar to the agreement we announced last year with Eli Lilly and described in the February 2013 issue of ddn [the previous name of DDNews],” Winther explains. “The framework setting makes it possible to easily move into a project-execution mode on our companion diagnostic development in relation to the Merck KGaA oncology therapeutic pipeline. Currently, the companion diagnostic projects being executed under this agreement apply the Dako core technologies of IHC and ISH (including IQFISH and CISH), but going forward technologies from the Genomics and Life Sciences part of Agilent are also to be considered.”

Dako 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 became part of Agilent Technologies in 2012.