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Dako, an Agilent Technologies Company, and ONO PHARMACEUTICAL CO., LTD. Announce Collaboration on Development of PD-L1 Companion Diagnostic Test for Investigational Cancer Drug Opdivo® (Nivolumab)


Dako, an Agilent Technologies company (“Agilent”) and a worldwide provider of cancer diagnostics, and ONO PHARMACEUTICAL CO., LTD. (“ONO”) announced a new partnership to develop a potential diagnostic test specifically for use with Opdivo in the treatment of non-small cell lung cancer (NSCLC). This test is being investigated for its diagnostic utility to determine which patients are most likely to respond to Opdivo.

Lung cancer is the most common cause of cancer-related mortality worldwide, and is responsible for more than 1.5 million deaths per year(1). The demand for personalized medicine continues to increase, as it may provide a way to both improve patient care and better manage health care costs by targeting treatment to the individuals most likely to benefit from it.

“We are pleased to be chosen as ONO’s partner for the development of a companion diagnostic test for this promising drug,” said Jacob Thaysen, president of Agilent’s Diagnostics and Genomics Group. “Today’s announcement follows several other collaborative agreements in the companion diagnostics area by Agilent’s Dako business.”

“We are delighted to collaborate with Dako, a global leader in diagnostics, and this partnership contributes to value maximization of Opdivo,” said Gyo Sagara, president, representative director and CEO, ONO.

The financial details of the agreement were not disclosed.

About Opdivo® (nivolumab)

Cancer cells may exploit “regulatory” pathways, such as checkpoint pathways, to hide from the immune system and shield the tumor from immune attack. Opdivo is an investigational PD-1 (programmed cell death-1) immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 expressed on activated T-cells. On July 4, 2014, ONO announced that Opdivo received manufacturing and marketing approval in Japan for the treatment of patients with unresectable melanoma, and sales of Opdivo started in Japan on Sept. 2, 2014. Opdivo is the world’s first approved and launched immune checkpoint inhibitor targeting PD-1.

About the Bristol-Myers Squibb and ONO PHARMACEUTICAL Collaboration

In 2011, through a collaboration agreement with ONO, Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where ONO had retained all rights to the compound at the time. On July 23, 2014, Bristol-Myers Squibb and ONO PHARMACEUTICAL further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies - as single agents and combination regimens - for patients with cancer in Japan, South Korea and Taiwan.


ONO PHARMACEUTICAL, headquartered in Osaka, Japan, is an R&D-oriented pharmaceutical company committed to creating innovative medicines that meet unmet medical needs at the frontline of healthcare, focusing especially on the areas of diabetes and oncology. For more information, please visit the company’s website at

About Agilent Technologies and Dako

Agilent Technologies Inc. (NYSE: A), a global leader in life sciences, diagnostics and applied chemical markets, is the premier laboratory partner for a better world. Agilent works with customers in more than 100 countries, providing instruments, software, services and consumables for the entire laboratory workflow. Agilent generated revenues of $4.0 billion in fiscal 2014. The company employs about 12,000 people worldwide. In 2012, Agilent acquired Dako, a well-known provider of reagents, instruments, software and expertise to make accurate diagnoses and determine the most effective treatment for cancer patients. Information about Agilent is available at and information about Dako products is available at

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(1) Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from:, accessed on Nov. 21, 2014. 



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