Gene editing and gene modulation technology company Horizon Discovery Group has entered into an agreement with Roche Diagnostics to assist in the development of immunohistochemistry (IHC) assays, it announced on Monday.
The AIM-traded firm said that under the terms of the agreement, Horizon would develop and provide reference standard material expressing neurotrophic tropomyosin receptor kinase (NTRK) fusion biomarkers.
NTRK gene rearrangements have recently emerged as promising targets for cancer therapy, and a number of novel compounds have been developed against the fusion proteins that arise from those molecular alterations, the Horizon board explained.
It said their effective application, however, depended upon the accurate determination of the genotype of patients, which was primarily carried out through IHC-based diagnostic testing.
Horizon's reference standards would be derived from cell lines generated using the company's industry-leading 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 would be supplied in formalin-fixed paraffin embedded (FFPE) format, thereby mimicking real patient samples for better control of variability across the complete diagnostic workflow.
Horizon said the project was expected to be completed within 12 months.
It added that the agreement built on the Horizon-Roche partnership announced in September 2016, which comprised the development, manufacture and commercialisation of cell line derivative materials for use as IHC reference standards in cancer tissue diagnostics, to support the development and validation of IHC assays.
"Horizon continues to establish itself as a leading supporter of the development and validation of molecular diagnostics by providing reliable and high quality reference standards to assay developers," said Horizon chief executive Dr Darrin M Disley.
"We are very pleased to announce this agreement, further strengthening our ongoing partnership with Roche, and we look forward to continuing to work alongside them as they develop additional important diagnostic assays in areas of significant need."