GALEAS™ uPCR: ESR1

ESR1 Mutation Detection in ER+/HER2- Breast Cancer

High-Sensitivity Detection of ESR1 Mutations in Liquid Biopsy Samples

GALEAS™ uPCR: ESR1 enables ultrasensitive detection of ESR1 mutations, a key driver of resistance to endocrine therapy in ER+/HER2- metastatic breast cancer. Using Nonacus proprietary ultrasensitive PCR (uPCR) technology, this assay offers improved sensitivity and specificity over standard qPCR, ensuring no wild-type bleed-through and delivering results comparable to digital PCR—without requiring specialist equipment.

The table of contents

Why ESR1 Mutation Testing Matters?

Up to 40% of ER+/HER2- metastatic breast cancer patients harbor ESR1 mutations, which contribute to endocrine therapy resistance
Clinical guidelines increasingly recommend ESR1 testing in metastatic breast cancer to guide treatment decisions
Liquid biopsy provides a minimally invasive method for detecting ESR1 mutations in real time

Key Features of GALEAS™ uPCR: ESR1

Detects 11 of the most prevalent mutations associated with endocrine therapy resistance
Developed for use with cell-free DNA (cfDNA)
Superior sensitivity and specificity over standard qPCR (≥98% specificity, ≥90% sensitivity)
No wild-type bleed-through, ensuring highly accurate mutation detection
Rapid results in under 3 hours with a simple workflow
Requires no specialist equipment, ideal for molecular diagnostic labs

Comprehensive ESR1 Mutation Coverage

High-Prevalence Mutations
E380Q, D53G, Y537S, Y537N
Low-Prevalence Mutation
S463P, Y537C, L536H, L536R, P535H, L536Q, Y537D

Performance

Tested using synthetic controls and reference standards
≥98% specificity and ≥90% sensitivity at mutant allele frequencies (MAF) between 0.04% and 0.33%
No wild-type bleed-through, ensuring precise detection of low-frequency mutations

Streamlined Workflow, Results in Under 3 Hours

From sample to data in less than 3 hours
Simple qPCR protocol that integrates seamlessly into existing workflows
No digital (dPCR) required, making it a cost-effective and more-accessible solution

Why Choose GALEAS™ uPCR: ESR1?

Accurate and sensitive

Key variants covered

Results in under 3 hours

Detect mutations in ESR1 with a specificity of ≥98% and a sensitivity of ≥90% at MAFs between 0.04% and 0.33%

Detect 11 actionable variants in the ESR1 gene from cell-free DNA in plasma

A fast, simple qPCR protocol that requires no specialist equipment and can be deployed in almost any molecular laboratory

Product Specifications

Method	Qualitative qPCR Test
Number of Targets	11 ESR1 variants
Sample Type	Cell-free DNA (cfDNA)
Input Amount	1-25 ng
Kit Format	32 Reactions per Multiplex (accommodates 29 samples when running x 3 controls)
Controls	3 positive and 1 negative
Protocol Length	Under 3 hours