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SEATTLE—NanoString Technologies Inc. has launched a collaboration agreement with Merck & Co., known as MSD outside of the United States and Canada, through a subsidiary. The agreement will focus on the development and commercialization of a novel diagnostic assay to predict patient response to Merck's anti-PD-1 therapy, Keytruda. Per the terms of the agreement, NanoString will assume responsibility for seeking regulatory approval for and commercialization of the diagnostic test, and in turn could receive up to $24 million for technology access and near-term milestones, as well as development funding and other potential regulatory milestone payments. The terms of the expanded collaboration agreement stipulate that NanoString will retain the flexibility to independently develop and commercialize additional indications for the resulting diagnostic assay.
 
"We look forward to working with NanoString on the development of their diagnostic assay to help identify patients who are most likely to benefit from KEYTRUDA in multiple additional tumor types," Dr. Eric Rubin, vice president of oncology early-stage development at Merck Research Laboratories, commented in a press release.
 
This is not the companies' first time working together; NanoString and Merck previously worked together under a research collaboration to develop an assay to evaluate the potential to predict benefit from treatment with Keytruda. This expanded collaboration is for the development and commercialization of the selected gene expression signature on NanoString's nCounter Dx Analysis System as a diagnostic assay to predict response to Keytruda in several different tumor types.
 
"We are excited to expand our collaboration with Merck to develop this novel assay for predicting response to anti-PD-1 therapies such as KEYTRUDA. We believe this gene signature has the potential to become the basis for a universally available assay that serves as the 'gold standard‘ for informing treatment with immuno-oncology therapies," Brad Gray, president and CEO of NanoString Technologies, commented in a statement on the deal. "This collaboration solidifies NanoString's position as the leader in immuno-oncology biomarker signatures, and builds on our ongoing research collaborations with MD Anderson and the Cancer Immunotherapy Trials Network."
 
NanoString also shared its financial results for the fourth quarter and full-year 2015. For Q4 2015, the company saw total revenue of $22.3 million, 43 percent higher than the same quarter last year, with a net loss of $8.8 million. For the full year 2015, the company's total revenue was $62.7 million, up 32 percent, while its net loss was $45.6 million. For 2016, NanoString is forecasting total revenue in the range of $86 million to $90 million, with operating expenses between $94 million and $99 million and net loss per share in the range of $2.30 to $2.45.

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