Driver mutations in the EGFR, BRAF, and KRAS genes represent a combined ~60% of all genomic variants driving oncogenesis of many solid tumor diseases, especially lung cancer. SeraCare is expanding its liquid biopsy portfolio with the addition of low-plex (single-gene) reference materials for clinically-validated biomarkers in these genes as ground-truth standards for molecular testing of circulating tumor DNA patient samples by PCR or NGS technologies. These products are designed for validation and standardization of clinical biomarkers in CLIA/CAP-accredited laboratory-developed tests (LDTs).
The Seraseq ctDNA EGFR ex19del Mutation Mix product has an allele frequency of 1%.
Size distribution similar to native cfDNA
Offered as a purified DNA mixture for ease of use during processing
Mutation precisely quantitated with digital PCR
Single well-characterized GM24385 human genomic DNA as background wild-type material
Manufactured in GMP-compliant and ISO 13485-certified facilities