The UK’s innovation agency, the Technology Strategy Board, has issued a research grant of more than $600,000 to two firms that will partner to standardize “liquid biopsy” tests for cancer diagnosis and monitoring.
More than half of the funding will go to Horizon Discovery Group plc, Cambridge, UK, an international life science company supplying research tools to organizations engaged in genomics research and the development of personalized medicines. Partnering on the grant is LGC, Teddington, UK, an international life sciences measurement and testing company.
The grant was awarded under the Technology Strategy Board’s collaborative research and development project, “Improving Cell and Tissue Analysis for Stratified Medicine,” and will fund a joint project run by Horizon’s 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 datasets 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.
“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,” said Paul Morrill, PhD, senior vice president of reagent products at Horizon. “Horizon is committed to investing in new, innovative areas related to cancer and diagnostics, supporting the increased implementation of stratified and personalized intervention strategies.”
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. In addition, the technique offers the potential for detection of metastasis and residual disease, as well as 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 such 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. Such standards do not allow for 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.
“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,” said Carole Foy, PhD, principal scientist of LGC’s molecular and cell biology department. “These standardization tools will be invaluable in ensuring the accuracy of the results when detecting tumor DNA in the bloodstream.”
For additional information visit Horizon Discovery.