SeraCare’s new line of Seraseq oncology reference materials caters to the needs of the oncology IVD developer and clinical pathology laboratory by offering scalability, flexibility, and commutability. The combination of scalability and flexibility offers the unique benefit of being able to customize genetic variants of interest to precise allelic ratios while meeting the demands of complex oncology test methods and platforms.
Biosynthetic DNA and engineered cell lines
The use of biosynthetic DNA and engineered cell lines provides the ability to adjust individual allele frequency or fetal fraction percentages to a given commonly accepted limit of detection. In addition, it enables the capability to customize a set of allele frequencies or fetal fraction percentages to customer requirements.
By using engineered cell lines and biosynthetic DNA targets, SeraCare can produce highly multiplexed reference standards for the demands of highly multiplexed assays that current NGS platforms provide. The ability to produce biosynthetic DNA with sequences that occur only rarely in patient samples solves the problem of sourcing these rare materials in limited supply.
Full process reference materials
SeraCare’s ability to produce stable circulating cell-free DNA in synthetic plasma-like material and formalin-fixed, paraffin-embedded cell lines means that Seraseq oncology products can serve as full-process reference materials, without the concern that any aspect of the sample handling process is not being monitored.
‘Full process’ means that these reference standards can be handled in an identical fashion as a patient sample including:
- Nucleic acid extraction
- NGS library construction
- Template preparation
- Data analysis
- Seraseq™ Tumor Mutation Mix v2 (AF1-10) HC
- Seraseq™ Tumor Mutation Mix v2 (AF1-4) HC
- Seraseq™ Tri-Level Tumor Mutation Mix v2 HC
- Seraseq™ Circulating Tumor DNA-I Mutation Mix Kit (AF5-WT)
- Seraseq™ Circulating Tumor DNA-I Reference Material (AF5)
- Seraseq™ NGS Reference Materials (RUO)
Seraseq’s unique scaling ability
Since the other technology used in the marketplace does not scale in the same manner as Seraseq technology does, it does not use biosynthetic DNA nor engineer cell lines in the same fashion. Also, it is not as flexible, due to inherent limitations in a genome-edited cell line approach mixing and blending cell lines to achieve desired frequencies of mutations.
Count on SeraCare for your oncology reference materials
- Reduce workload of creating your own limited supply of control and reference materials
- Reduce troubleshooting time to better allocate resources to the goal of your lab
- Conserve laboratory budget by running multiplexed reference materials
- Rely on highly accurate and precise products due to digital quantitation methods
- Order oncology reference materials in either a purified format for assay optimization or full-process materials to monitor every step of your lab workflow