Gencurix announced that its liquid biopsy breast cancer ESR1 mutation diagnostic product has demonstrated high reliability in a multi-center study conducted in Germany. The study showed a 96.8% concordance rate compared to high-sensitivity next-generation sequencing (NGS) technology.
The study used Gencurix’s digital PCR-based Droplex ESR1 Mutation Test v2 and analyzed data from approximately 6,000 cancer patients. The research was conducted at several institutions, including Charité University Hospital in Germany and the Hamburg Institute of Pathology.
Results revealed that the detection rate of ESR1 mutations in liquid biopsies from 354 metastatic breast cancer patients who received endocrine therapy (ET) reached 43%.
Furthermore, low-frequency mutations with a variant allele frequency (VAF) of roughly 0.5% were consistently found. They demonstrated a high concordance rate when 32 patient plasma circulating free DNA (cfDNA) samples were directly compared using the Dropplex product and a high-sensitivity NGS assay.
ESR1 mutations are linked to resistance to endocrine therapy. Early detection and subsequent treatment adjustments can potentially more than double progression-free survival (PFS). In light of this, the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) recommend regular liquid biopsy-based testing for ESR1 mutations.
Gencurix explained that the Dropplex product can be a cost-effective alternative in clinical settings. It also stated that it has clinical value as a companion diagnostic technology for US Food and Drug Administration (FDA) and European Medicines Agency (EMA)-approved treatments and new drugs under clinical development.
Liquid biopsy-based digital PCR analysis offers rapid ESR1 mutation detection, providing same-day results faster than NGS tests. This approach facilitates repeat testing and real-time monitoring while reducing patient costs.
Meanwhile, Gencurix provides a diagnostic platform with digital PCR-based high-sensitivity analysis technology. The Dropplex ESR1 mutation test has obtained European in vitro diagnostic device certification (CE-IVD) and is currently used for routine diagnostic testing in the European market, starting with Germany.
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