| Background and Introduction

Cell-free DNA (cfDNA) found in the plasma or serum is derived from multiple sources, including tumor cells. The fraction of cfDNA derived from tumor cells is termed circulating tumor DNA (ctDNA). The analysis of circulating tumour DNA(ctDNA) is currently one of most promising technical advances to provide an alternative to tumour biopsy. Translating the application of ctDNA detection into the clinic requires stringent procedures to enable both accurate and precise measurements. 

GeneWell's ctDNA reference standards are highly-characterized, biologically-relevant reference materials used to assess the performance of cfDNA assays that detect somatic mutations, including quantitative PCR, next-generation sequencing, and other novel assays.

ctDNA controls are developed using clinically-relevant mutations in an artificial matrix to give you full control of your cfDNA workflow, reducing the likelihood of a false negative or positive due to incorrect assay loading.Genomic DNA has been fragmented to 160 bp to closely resemble cfDNA derived from patient samples.
The ctDNA Reference Standards covers multiple engineered single nucleotide variants (SNVs/SNPs) with clinically-relevant mutations  such as EGFR, KRAS, ALK, BRAF etc. Batch-specific copy number values measured via ddPCR are provided.

These ctDNA controls contain a series of multiple and single nucleotide variants products. Onco SNV Multiplex ctDNA Reference Standard Set have a range of precisely defined allelic frequencies can help determine a true limit of detection and reduce the risk of false positives.

| ctDNA fragments distributions

DNA fragments distributions figure of two ctDNA reference standards and the free DNA fragments in real plasma:

| Key Features

● Cell line-derived sample for the closest representation of the  patient sample. 

● Fragment size of 160 bp. 

● Mutations are provided in a wide range of allelic frequencies, together with matched wildtypes. 

● ddPCR validation for multiple variants with defined allelic frequencies. 

● Enzyme fragmentation also available upon request.

| Product List