Roche has tasked Horizon Discovery with developing reference standard material that expresses NTRK fusion biomarkers. The agreement supports Roche’s drive to develop immunohistochemistry (IHC) assays that enable doctors to identify patients with NTRK gene rearrangements.
Cambridge, U.K.-based Horizon will apply its gene editing platform to the task. Using the platform, Horizon plans to develop cell lines that include knock-ins of NTRK 1,2 and 3 fusion cDNA. These will each be controlled by multiple promoters. Horizon will supply the cell lines in the formalin-fixed paraffin embedded format, a method it thinks controls variability by mimicking patient samples.
Roche is due to receive the finished materials within 12 months.
Interest in IHC tests capable of identifying patients with NTRK gene rearrangements has increased in line with data on the effect of TRK inhibitors in certain cancer patients. These drugs, notably Loxo Oncology’s larotrectinib, have wowed with data linking them to objective responses in most patients.
Roche has a specific interest in the field.
Nine months ago, Roche’s Ventana Medical Systems signed up to develop a pan-TRK companion diagnostic for Loxo’s larotrectinib. That deal put Roche in charge of further developing an IHC test Loxo had already advanced part way to optimization and validation. Roche’s role is to finish the job using its OptiView DAB detection technology.
In turning to Horizon for support, Roche has built upon a relationship it entered into last year. The original deal also leveraged Horizon’s cell line capabilities to support the development of IHC cancer assays.