Seraseq® ctDNA MRD Panel Mix

INTRODUCTION

MRD monitoring typically involves measuring signs of a cancer in order to determine if it is disappearing (progression) or returning (relapse). 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 have been adopted by leading liquid biopsy NGS vendors such as Natera’s Signatera® platform and Archer/Invitae’s Personalized Cancer Monitoring (PCM) assay.

LGC SeraCare has developed a novel ctDNA MRD mutation mix panel designed to support the development, validation and clinical deployment of ctDNA-based patient-derived MRD monitoring NGS assays. The new Seraseq ctDNA MRD Panel Mix product is constructed from combination of a diseased human cell line, its SNP-matched normal cell line, and biosynthetic DNA containing variants commonly targeted by therapeutic drugs (see list below). The blended DNA is fragmented, sized to mimic ctDNA fragment sizes, and serially diluted to tumor fractions (TF) of 0%, 0.5%, 0.05% and 0.005%.

FEATURES AND BENEFITS

• Combination of diseased human cancer cell line, its SNP-matched normal and biosynthetic DNA variants.
• Fragmented, sized (ctDNA), and blended at four tumor levels: 0% (WT), 0.5%, 0.05% and 0.005%.
• Develop, validate and routinely determine presence/absence of patient-derived disease variants with high precision (against a matched normal (WT) background).
• Variant detection and VAF analysis by digital PCR and targeted cfDNA NGS assay.
• Available as a purified DNA mix ready for targeted sequencing library prep.
• Manufactured in GMP-compliant and ISO 13485-certified facilities.

Specifications

Documents

• Seraseq® ctDNA MRD Mix (Product Sheet)
• Seraseq ctDNA MRD Panel Mix - Datasheet (Data Sheet)
• Seraseq ctDNA MRD Mix - Package Insert (Package Insert)
• Seraseq ctDNA MRD Panel Mix Non-Requirement Letter (SDS Non-Requirement Letter)

Ordering Information