Super-ARMS ESR1 PCR Kit

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This article was last updated in August 2025.

ESR1 mutations are a key mechanism of acquired resistance in hormone receptor-positive (HR+)/HER2-negative metastatic breast cancer, impacting patient prognosis and guiding treatment decisions for second-line endocrine therapy. With a detection sensitivity as low as 0.2% mutant allele frequency, this kit enables in-house laboratories to accurately identify 29 ESR1 mutations, helping clinicians monitor endocrine therapy resistance and optimize treatment strategies.

Clinical Utility

• Identify Resistance Mechanisms: ESR1 mutations are present in ~20–40% of HR+/HER2- metastatic breast cancer patients who progress on aromatase inhibitors. Detecting these mutations informs treatment adaptation to overcome endocrine resistance.
• Guide Treatment Selection: ESR1 mutation-positive patients benefit from targeted therapies such as elacestrant, which has been shown to significantly reduce disease progression risk compared to standard treatments.
• Improve Prognostic Assessment: Carrying ESR1 mutations is associated with distinct prognostic characteristics, providing important information for patient stratification and supporting personalized care decisions.

Product Features

• Intended Use: Reseach Use Only
• Technology: Super-ARMS real-time PCR
• Sample Type: Liquid biopsy (cfDNA from plasma)
• Sensitivity: Detects mutant allele frequency as low as 0.2%
• Coverage: 29 ESR1 mutations
• Format: Pre-loaded, ready-to-use reagent tubes
• Automated Analysis: ARAS software for streamlined result interpretation

Why Choose AmoyDx® Super-ARMS ESR1 PCR Kit?

High Sensitivity Aligned with Clinical Conditions: AmoyDx’s performance is validated under clinically relevant sample conditions (~1500 copies), ensuring reliable results for real-world samples.

Rapid Turnaround, In-House Control: By enabling local testing, laboratories can avoid the long turnaround times typical of send-out testing; delivering faster, actionable results.

Validated Performance – Whitepaper Highlights

A new whitepaper published by AmoyDx® further confirms the robust analytical performance of the Super-ARMS ESR1 PCR Kit. The study evaluated samples with 11 ESR1 variants identified in the SERENA-1 clinical study, demonstrating the assay’s value for monitoring endocrine therapy resistance and enabling serial testing via liquid biopsy.

Key findings include:

• High Sensitivity: Achieves a 0.2% Limit of Detection (LOD), surpassing conventional qPCR assays and enabling reliable detection of low-frequency ESR1 mutations in cfDNA.
• Excellent Specificity: Across varying DNA inputs (10–60 ng), the assay consistently demonstrated 100% specificity, ensuring high confidence and minimizing false positives.
• Rapid Turnaround: The entire workflow can be completed in under 3 hours without the need for specialized instruments, supporting routine laboratory adoption.

The whitepaper highlights how the proprietary Super-ARMS technology combines advanced primer design and optimized reaction conditions to preferentially amplify mutant alleles while suppressing wild-type background. This ensures superior analytical performance ideally suited for precision oncology research.

By publishing this study, AmoyDx® reinforces its commitment to providing accurate, accessible, and clinically relevant molecular diagnostics that empower clinicians and researchers to better guide treatment strategies in breast cancer.

Although the AmoyDx® Super-ARMS ESR1 PCR Kit is for Research Use Only (RUO), the EMA approval for elacestrant (ORSERDU™) states that where a CE-IVD assay is not available, a validated assay may be used to guide treatment decisions. You can refer to the EMA product information here: https://www.ema.europa.eu/en/documents/product-information/orserdu-epar-product-information_en.pdf