Seraseq® ctDNA MRD 0.05% Tumor

MRD monitoring typically involves measuring signs of a cancer in order to inform decisions about treatment escalation and de-escalation. Typically, this can be facilitated by use of less invasive techniques such as liquid biopsy (ctDNA), to monitor cancer-specific somatic variants. A patient-derived approach to the application of ctDNA-based MRD monitoring starts with a tumor profiling analysis to identify clinically relevant tumor variants that constitute the patient’s genomic profile. Following this, a targeted panel/assay containing a subset of the gene variants can be designed for disease monitoring by detecting presence or absence of circulating tumor (ct) DNA variants in the patient’s blood sample. These patient-derived MRD analyses represent a paradigm shift in disease monitoring and are rapidly being developed by many assay vendors while best clinical practices are being developed in parallel.

SeraCare has developed a novel ctDNA MRD mutation mix designed to support the development, validation and clinical deployment of a ctDNA-based patient-derived MRD monitoring NGS assays. The new Seraseq ctDNA MRD Mix product is constructed from a combination of a diseased human cell line, its SNP-matched normal cell line, and biosynthetic DNA containing variants commonly targeted by therapeutic drugs. The blended DNA is fragmented, sized to mimic ctDNA fragment sizes, and serially diluted to tumor fraction (TF) of 0.05%.