SeraCare Life Sciences, Milford, Mass, has launched Seraseq Circulating Tumor DNA v2 reference materials, aimed to closely mimic the performance attributes of ctDNA derived from clinical specimens.
SeraCare developed a unique patent-pending technology that produces a DNA fragment size-distribution that closely mimics native cfDNA, while decreasing DNA damage relative to ultrasonicated material. The result is a renewable source of characterized material that exhibits similar performance when treated identically to a patient sample. The Seraseq ctDNA v2 requires no special workflow considerations to generate informative data. This is especially important for validation studies that require strict adherence to standard operating procedures.
The product contains 40 somatic mutations, including such important alterations for ctDNA analysis as BRAF V600E, EGFR T790M, an EGFR exon 19 deletion, and KRAS G12D. Variants are present against a single well-characterized genomic background across a range of allele frequencies down to 0.125%, which ensures utility for assays with different limits of detection.
“One of the biggest challenges in developing highly sensitive ctDNA assays is the lack of reference materials that perform like real-world samples and contain all of the relevant variants,” says Jason Myers, CEO at ArcherDX. “Seraseq ctDNA reference materials resemble native cfDNA, from preanalytic assessment of DNA quality through sequencing. We expect these new references will greatly facilitate our assay development, and they also potentially will help our customers execute an effective QC strategy. Our longstanding relationship with SeraCare continues to result in products that fit previously unmet needs for next-generation liquid biopsy analysis.”
“As an industry leader for clinical genomics reference materials, we have spent significant time with subject experts to thoroughly understand the challenges ctDNA technologies face, and what is needed to effectively accelerate assay development and adoption in the clinic,” says Russell Garlick, PhD, chief scientific officer at SeraCare.