Horizon Discovery Group has entered into an agreement with Roche Diagnostics to assist in the development of immunohistochemistry (IHC) assays. Under the terms of the agreement, Horizon will develop and provide reference standard material expressing neurotrophic tropomyosin receptor kinase (NTRK) fusion biomarkers.
Recently, NTRK gene rearrangements have emerged as promising targets for cancer therapy, and a number of novel compounds have been developed against the fusion proteins that arise from these molecular alterations. Their effective application, however, depends on the accurate determination of the genotype of patients, which is primarily carried out through IHC-based diagnostic testing.
Horizon’s reference standards will be derived from cell lines generated using the company’s gene editing platform to include knock-ins (KI) of NTRK 1,2 and 3 fusion cDNA (each under the control of multiple promoters), to achieve low to high levels of protein expression in selected cell lines. The cells will be supplied in formalin-fixed, paraffin wax-embedded (FFPE) format, thereby mimicking real patient samples for better control of variability across the complete diagnostic workflow. The project is expected to be completed within 12 months.