cfDNA Reference Standards
A major clinical goal, especially for oncology, is to achieve non-invasive disease assessment and progression monitoring. The analysis of cell free DNA (cfDNA), also known as circulating tumor DNA (ctDNA) is currently the most promising technical advances to provide an alternative to tumor biopsy. Translating the application of cfDNA detection into the clinic requires stringent procedures to enable both accurate and precise measurements. Meanwhile cfDNA detection methodologies face new challenges due to the low quantity of highly-fragmented material available from biofluids. Analysis of cfDNA is often intended to identify very low allele frequency mutations, including 0.1% and lower, that push the detection limits of current technologies. Until now, the availability of reference standards or a universal control to assess cfDNA/ctDNA analytical workflows has broadly been limited to variable clinical specimens. In response to this need, Horizon has developed the cfDNA Reference Standard range to support the innovation and standardization of this valuable technology. Derived from engineered human cell lines, the reference standards are provided as fragmented human genomic DNA (average size 160 bp) resembling cell tumor DNA derived from human plasma. The reference standards are provided at allelic frequencies down to 0.1% across a range of variants with a matched wild type. Copy number concentrations and expected allelic frequencies of each product are provided, ideal to support the breath and quality of data you need for validation. These reference standards will help to drive forward the development, validation and demonstration of the performance of cfDNA assays and platforms on a routine basis.
Horizon Discovery Latest cfDNA Reference Standards:
Myeloid Cancer Panel cfDNA Reference Standard
Now available in cell-free DNA format to validate minimal residual disease assays
The Myeloid Cancer Panel cfDNA reference standard is a well-characterized cell line-derived control which contains 15 clinically-relevant variants across 14 genes. This cell-free DNA reference material allows labs to perform reliable and cost-effective validations of myeloid cancer liquid biopsy assays. QC pipelines are supported by controls manufactured under ISO:13485 with low allele frequencies, designed specifically to replicate cell-free patient samples in minimal residual disease (MRD) and liquid biopsy assays.
Prostate Cancer Panel cfDNA Reference Standard
15 variants across 9 genes clinically relevant to prostate cancer
The Prostate Cancer Panel cfDNA Reference Standard is a well characterized, cell line-derived control material manufactured under ISO:13485 that contains 15 variants across 9 genes clinically relevant to prostate cancer. This exciting new Multigene Multiplex product allows labs to perform fast, more reliable, and cost-effective validation of prostate cancer sequencing assays - saving the user time and money to achieve their quality assurance goals faster and allowing the user to assess the performance of cfDNA assays.
Consistency in end-to-end workflow validation and routine monitoring with patient-like molecular material
Horizon Discovery reference standards are cell line-derived, which means they maintain genomic complexity whilst mimicking patient material from sample preparation to downstream analysis. Suitable for Next Generation Sequencing, droplet-digital and Real-Time PCR as well as Sanger sequencing, Horizon reference standards are platform-agnostic for easy implementation into any quality control workflow.
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