Medivation and NanoString Technologies have entered into a collaboration worth up to $22 million with Astellas Pharma to pursue a gene expression signature algorithm from Medivation and create a companion diagnostic assay using NanoString's nCounter® Dx Analysis System.

NanoString will be responsible for developing and validating the diagnostic test, seeking regulatory approval, and commercialization, for which it will be eligible to receive up to $22 million for technology access, near-term milestones, and development funding, with other potential undisclosed downstream payments possible.

The agreement involves NanoString modifying its PAM50-based Prosigna® Breast Cancer Assay for potential use as a companion diagnostic test for enzalutamide for triple negative breast cancer, based on data from a Phase II trial conducted by Medivation and Astellas that evaluated enzalutamide in patients with triple negative breast cancer.

Amy Peterson, M.D., Medivation vice president of clinical development, states, “Triple negative breast cancer has no recognized target and standard therapy is therefore cytotoxic chemotherapy. This diagnostic has the potential to identify patients with triple negative breast cancer appropriate for treatment with enzalutamide.”

Brad Gray, president and CEO of NanoString Technologies, adds, “We're also pleased to have the opportunity to leverage our PAM50-based Prosigna breast cancer franchise, potentially expanding its role in informing breast cancer treatment decisions and enhancing the description of the intrinsic biology of breast cancer to aid in therapeutic treatment decisions.”

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