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NanoString, Merck Partner to Develop CDx for Anti-PD-1 Therapy

NEW YORK (GenomeWeb) – NanoString Technologies announced today that it has signed a collaboration agreement with Merck to develop a companion diagnostic to the pharmaceutical company's anti-PD-1 cancer therapy Keytruda (pembrolizumab).

Under the terms of the deal, NanoString will be responsible for developing, commercializing, and seeking regulatory approval for a diagnostic assay on NanoString's nCounter Dx Analysis System to predict patient response to Keytruda. The company will receive funding from Merck for the development of the diagnostic, and will be eligible for up to $24 million for completing certain near-term milestones, as well as possible additional regulatory milestone payments.

The companies signed a collaboration agreement in May 2015 to develop an assay to evaluate the potential to predict Keytruda's benefit to patients.

"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," said NanoString President and CEO Brad Gray in a statement. "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."

Merck also recently signed a similar collaboration deal with Myriad and Tesaro to use Myriad's myChoice HRD companion diagnostic in a clinical trial of an investigational drug therapy combining Tesaro's PARP inhibitor, niraparib, with Keytruda. The pharmaceutical companies will use the Myriad diagnostic to identify potential responders and evaluate treatment response in patients with triple negative breast cancer or ovarian cancer.

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