Seraseq® Endometrial Cancer DNA Mix

Endometrial cancer, a malignancy of the uterine lining, is the sixth most common cancer in women worldwide. It is one of the few cancers with rising mortality rates, primarily driven by higher incidence of high-risk subtypes, lifestyle changes, and aging population. Current clinical practice is shifting from traditional histopathological classification towards molecular profiling to guide prognosis, treatment decisions, and clinical trial eligibility. Guidelines from international organizations like NCCN, ESGO, ESMO and WHO, recommend molecular stratification as part of standard of care for patients with endometrial cancer.

The molecular framework for endometrial cancer is divided into four major subtypes as defined by The Cancer Genome Atlas (TCGA): POLE-mutated, mismatch repair deficient (MMRd), p53-abnormal (copy number high) and NSMP (no specific molecular profile, copy number low). As genomic profiling becomes increasingly central to clinical decision-making, there is a growing need for well-characterized, highly multiplexed reference material to support confident detection of mutations across these key subtypes.

To support this need, LGC has developed the Seraseq®️ Endometrial Cancer DNA mix, containing a defined set of clinically relevant mutations spanning the major molecular subtypes including POLE, TP53, PTEN, PIK3CA, and MMR genes. This multiplexed reference material enables labs to develop, validate, and monitor assay performance, ensuring reliable and consistent variant detection, ultimately supporting high quality genomic testing outcomes.

FEATURES and BENEFITS 

- 32 variants in 16 genes, covering hotspot mutations from the four major

molecular subtypes, including 11 pathogenic POLE variants

- All variants are targeted at a VAF of 10% and CNV at +3 copies

- Mutation targets quantified by highly sensitive digital PCR and orthogonally validated by NGS

- Blended with well-characterized GM24385 human genomic DNA as background wildtype material

- Manufactured under GMP-compliance and ISO 13485-certified facilities