Asuragen – QuantideX ESR1 exoMutation Kit

Last updated: 28th May, 2025

ESR1 Mutations are the Leading Cause of Primary Treatment Resistance in HR+ mBC

ESR1 gene codes for estrogen receptor alpha (ERα), and mutations in its ligand-binding domain trigger constant activation of the receptor, leading to excessive downstream signalling. These mutations have become a critical biomarker for predicting resistance to treatment in patients with hormone receptor-positive (HR+), metastatic breast cancer (mBC). Although extremely rare in patients who have not undergone therapy, ESR1 mutations are found in up to 40% of mBC cases after extended exposure to endocrine therapy (ET), resulting in therapy failure and disease progression. Clinical trials are actively exploring whether switching treatment upon the detection of ESR1 mutations can significantly delay disease progression. Promising new therapies targeting ESR1-mutated cancers are emerging to address this mechanism of resistance to primary treatments.


Bringing High-Sensitivity ESR1 Mutation Testing to qPCR – Asuragen QuantideX® qPCR ESR1 exoMutation Kit (RUO)*

Asuragen QuantideX qPCR ESR1 exoMutation Kit is an in vitro nucleic acid amplification kit for the qualitative detection of variants located in the ligand binding domain of the Estrogen Receptor 1 (ESR1) gene. The Kit is designed for reverse transcription and preamplification on DNA and RNA extracted from the plasma fraction of human whole blood performed on a thermal cycler, followed by qPCR. Data analysis is performed using the QuantideX qPCR ESR1 exoMutation Analysis Module which is designed to report the presence or absence of the targeted variants.


Controls included in the QuantideX qPCR ESR1 exoMutation Kit

Within Sample Control (IC1, IC2 & IC3) Internal Controls An Internal Control (IC) is included in all 3 mixes (A, B & C). Because we don’t require users to quantitate their qPCR input, the IC informs the user if they have added adequate sample into each testing well, removing the requirement to quantitate starting input.
Batch Controls Positive Controls

The Positive Control (CONP) is a DNA based control for 6 of the 11 targeted mutations. Each mix contains 2 mutations as a positive control and the internal control.

  • Mix A: D538G & S463P
  • Mix B: Y537X & E380Q
  • Mix C: L536X & V422del

The Positive Control demonstrates successful qPCR via positive signal in all 3 mixes across 2 mutant channels and in the internal control channel.

Negative Controls The Negative Control (CONN) is an RNA based negative control. It acts as:

  • A batch contamination control.
  • Demonstrates a successful Reverse Transcriptase (RT) reaction within the RT-qPCR workflow via positive signal in all 3 mixes in the internal control channel.

Bring exosome-powered, high-sensitivity ESR1 mutation testing to qPCR

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Visit the Asuragen QuantideX ESR1 Mutation Testing webpage

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* The QuantideX qPCR ESR1 exoMutation Kit is for Research Use Only (RUO) and not for use in diagnostic procedures.

THESE PRODUCTS ARE NOT AVAILABLE FOR PURCHASE BY THE GENERAL PUBLIC.

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