QClamp Liquid Biopsy Technology (QLBT) Rapid Sensitive Detection of Somatic Mutations in Tumor Derived DNA from Whole Blood

摘要

Distant tumor metastases harbor unique genomic characteristics not detectable in the corresponding primary tumor of the same patient and metastases located at different sites show a considerable intra-patient heterogeneity. Thus, the mere analysis of the resected primary tumor alone (current standard practice in oncology) or, if possible, even reevaluation of tumor characteristics based on the biopsy of the most accessible metastasis may not reveal sufficient information for treatment decisions. This dilemma can be solved by a new diagnostic concept: liquid biopsy, that is, analysis of therapeutic targets and drug resistance-conferring gene mutations on circulating tumor cells (CTC) and cell-free circulating tumor DNA (ctDNA) released into the peripheral blood from metastatic deposits. To meet the unmet clinical need, we have developed QClamp liquid biopsy technology (QLBT). The technology is unique in that we utilize a synthetic sequence specific xeno-nucleic acid (XNA) clamping probe to suppress amplification of wild-type template in the sample and only mutant templates are amplified in the qPCR reaction. The technology is particularly suited to 'liquid biopsy' applications for the detection of tumor derived cell-free DNA in whole blood, plasma or urine, which enables CTCs and ctDNA to be effective biomarkers in clinical oncology.