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The AmoyDx® Super-ARMS ESR1 PCR Kit is a qualitative real-time PCR assay developed for the detection of 29 somatic mutations in the ESR1 gene across exons 4, 5, 6, 7, and 8, using circulating free DNA (cfDNA) extracted from plasma samples. cfDNA, originating from apoptotic and necrotic tumor cells, can be detected in the peripheral blood of breast cancer patients. Plasma-based detection of ESR1 mutations offers a non-invasive method to assess the mutation status in breast cancer patients. However, due to the highly fragmented nature and low concentration of cfDNA in the bloodstream, especially in early-stage breast cancer patients compared to those with advanced disease, peripheral blood testing is more suitable for late-stage cases.
This kit is compatible with the QuantStudio 5 and SLAN-96S  platforms for testing and data collection. Results could be analyzed manually or using ARAS, a tool to aid in the interpretation of AmoyDx® Super-ARMS ESR1 PCR Kit.



Comprehensive ESR1 Gene Coverage




 

White Paper


1. AmoyDx® Super-ARMS ESR1 Performance Evaluation


The AmoyDx® Super-ARMS ESR1 PCR Kit exhibits high sensitivity and specificity in detecting 11 clinically prevalent ESR1 mutations within the Seraseq ESR1 reference panel. Utilizing ultrasensitive Super-ARMS technology, this assay achieves a limit of detection (LOD) of 0.2% with a 30ng DNA input, offering superior detection sensitivity compared to conventional qPCR methods. It provides laboratories with a user-friendly solution compatible with standard molecular equipment. The platform surpasses next-generation sequencing (NGS) in operational simplicity, cost-effectiveness, and rapid turnaround time (TAT), making it an efficient and reliable choice for ESR1 mutation detection.

Covers 29 ESR1 mutations

Covers 29 ESR1 mutations

Limit of detection as low as 0.2%

Limit of detection
as low as 0.2%

Cost-efficient

Cost-efficient

Turnaround time within 5.5 hours

Turnaround time
within 5.5 hours

Specifications

Tests/kit
14
Sample type
cfDNA extracted from plasma sample
Instrument
QuantStudio 5, SLAN-96S

Technology

Super-ARMS® represents an advancement over traditional ARMS technology achieved through enhanced primer and probe design.
With Super-ARMS, efficient amplification occurs when the 3’ base of the primer perfectly matches the mutant template. Conversely, if the 3’ base mismatches with the wild-type template, amplification efficiency is significantly reduced.

The refined primer design significantly enhances both specificity and sensitivity, offering improved performance in mutation detection.

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