NEW YORK (GenomeWeb) – Horizon Discovery Group today announced it and life sciences measurement and testing firm LGC have received a £360,224 ($612,000) research grant to develop novel reference standard materials for clinical diagnostics.
The grant from the UK's Technology Strategy Board will fund a joint project run by the Horizon Diagnostics division in partnership with LGC to establish methods and cross-platform data sets to standardize existing liquid biopsy genetic diagnostic tests. The standards are being developed to determine test sensitivity and to help drive the development of more sensitive systems and training and proficiency testing schemes for pathology laboratories, Horizon said.
Horizon will use its gene editing expertise and Genesis platform to engineer cell lines carrying cancer genetic biomarkers in order to generate reference standard material, including formalin-fixed, paraffin-embedded cell blocks and genomic DNA. LGC will develop methods based on digital PCR for value assignment of reference materials. It will also test the reference standard material produced by Horizon and will develop these methods for highly accurate and sensitive detection of tumor DNA in the bloodstream.
While advances in next-generation sequencing and digital PCR are driving genomic and genetic cancer diagnostics development, the practical application and validation of such tests in the clinic require the availability of reproducible and reliable reference standard material, Horizon said. Current standards, it added, have a high degree of variability, as well as heterogeneity because they are based on clinical samples, tumor-derived research cell lines, or home brew kits using plasmid DNA, "and therefore do not allow comparisons between operators, platforms, or labs."