Horizon Discovery™ Group plc has announced, together with LGC that they have been offered a research grant of £360,224 ($608,000 USD) by the UK’s innovation agency, the Technology Strategy Board, of which Horizon will receive more than half of the funding.
The grant is awarded under the Technology Strategy Board’s Collaborative Research and Development (CR&D) project ‘Improving Cell and Tissue Analysis for Stratified Medicine’ and will fund a joint project run by the Company’s Horizon Diagnostics division in partnership with LGC.
The project will fund the research and development of a portfolio of novel reference standard materials in order to serve a high need area of clinical diagnostics. The program will establish methods and cross platform data sets to standardize existing ‘liquid biopsy’ genetic diagnostic tests, to determine test sensitivity, and to help drive the development of new more sensitive systems as well as training and proficiency testing schemes for pathology laboratories.
Minimally invasive ‘liquid biopsies’ of tumor cells and tumor DNA from the bloodstream can enable earlier primary and secondary diagnosis compared to solid tumor biopsies, as well as detection of metastasis and/or residual disease, and ‘real time’ monitoring of treatment effectiveness that isn’t possible with solid biopsy methods. Standardization within and between facilities and across geographies will enable the uptake of minimally invasive cancer diagnostics as a routine clinical procedure.
Advances in next generation sequencing (NGS) and digital PCR (dPCR) are driving the next generation of genomic and genetic cancer diagnostics, however the practical application and validation of these diagnostic tests in the clinic requires availability of reproducible, reliable reference standard material.
Currently used ‘standards’ actually have a high degree of variability and heterogeneity as 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.
Horizon will use its gene editing expertise and GENESIS™ platform (comprising rAAV, CRISPR/Cas9 and ZFN technologies) to precisely engineer cell lines carrying cancer genetic markers. These cell lines will be used to generate reference standard material including formalin-fixed paraffin embedded (FFPE) cell blocks and genomic DNA (gDNA).
LGC, which is the UK’s designated National Measurement Institute (NMI) for chemical and bioanalytical measurement, is developing methods using digital PCR for accurate value assignment of reference materials, and will test the reference standard material produced by Horizon. LGC is also developing these methods for highly accurate and sensitive detection of tumor DNA in the bloodstream.
Dr Paul Morrill, Senior Vice President of Reagent Products, Horizon commented: “We are delighted to receive this grant from the Technology Strategy Board that will enable Horizon, in partnership with LGC, to continue to drive developments in the cancer diagnostics field. Horizon is committed to investing in new, innovative areas related to cancer and diagnostics, supporting the increased implementation of stratified and personalized intervention strategies.”
Carole Foy, Principal Scientist from LGC’s Molecular and Cell Biology department, added: “The combination of Horizon’s reference materials and LGC’s assays - PCR primers and probes - gives the potential for development of kits that clinical laboratories can use with their existing platforms. These standardization tools will be invaluable in ensuring the accuracy of the results when detecting tumor DNA in the bloodstream.”