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 the purpose of validation and standardization of clinical testing of these biomarkers in CLIA/CAP-accredited laboratory developed tests (LDTs), starting with the EGFR T790M variant.
This specific Seraseq ctDNA EGFR T790M product has an allele frequency of 0.1%.
Size distribution similar to native ctDNA
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