19 May 2025

AmoyDx® Super-ARMS ESR1 PCR Kit

AmoyDx® Super-ARMS ESR1 PCR Kit is a highly sensitive real-time PCR assay for detecting ESR1 mutations from plasma cfDNA (liquid biopsy).


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.


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

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