Mutated human oncogene recombinant nucleosomes as reference materials for liquid biopsy

突变人癌基因重组核小体作为液体活检参考材料

基本信息

批准号：
10090714
负责人：
金额：
$ 1.35万
依托单位：
VOLITION DIAGNOSTICS UK LIMITED
依托单位国家：
英国
项目类别：
Collaborative R&D
财政年份：
2024
资助国家：
英国
起止时间：
2024 至无数据
项目状态：
未结题

来源：
https://gtr.ukri.org/projects?ref=10090714
关键词：
Mutated human oncogene recombinant nucleosomes

项目摘要

Circulating tumour DNA (ctDNA) sequencing of plasma samples is becoming commonplace in clinical oncology practice and holds the promise to revolutionise cancer disease diagnosis and management. This promise is impeded by poor standardisation of ctDNA sequencing workflows, particularly in the pre-analytical phase. Limited control materials are currently available and published approaches often apply synthetic oligonucleotides. However, ctDNA does not circulate as free nucleic acid but predominantly as nucleosomes (DNA-histone protein complexes).Volition is the world leader in the production of recombinant-nucleosomes. These are single nucleoprotein complexes designed with the same structure in which mutated ctDNA circulates in the blood of cancer patients. These materials have the potential to fulfil the requirements of the International Liquid Biopsy Standardization Alliance for reference materials to control, monitor and standardise liquid biopsy end-to-end process from pre-analytic cell-free DNA (cfDNA) extraction through technology/assay validation and for QC of clinical sample collection and analysis.The proposed project will involve the characterisation of recombinant-nucleosome materials in terms of quantity, purity, aggregation, integrity and stability as well as their commutability with respect to native patient nucleosomes.

血浆样品的循环肿瘤DNA（CTDNA）测序在临床肿瘤学实践中变得司空见惯，并有望改变癌症疾病诊断和管理。 CTDNA测序工作流程的标准化不佳，尤其是在分析前阶段，这会阻碍这种承诺。目前可以使用有限的控制材料，并且已发表的方法通常采用合成寡核苷酸。然而，ctDNA并不是作为游离核酸循环，而是主要作为核小体（DNA - 固定蛋白复合物）循环。VOLITION是重组核小体产生的世界领导者。这些是具有相同结构的单核蛋白复合物，其中突变的ctDNA在癌症患者的血液中循环。 These materials have the potential to fulfil the requirements of the International Liquid Biopsy Standardization Alliance for reference materials to control, monitor and standardise liquid biopsy end-to-end process from pre-analytic cell-free DNA (cfDNA) extraction through technology/assay validation and for QC of clinical sample collection and analysis.The proposed project will involve the characterisation of recombinant-nucleosome materials in terms of quantity, purity, aggregation, integrity and stability as以及它们相对于天然患者核小体的可接合性。