QuantideX® qPCR ESR1 exoMutation Kit*†
ExoLution™ Plus cfDNA + exoRNA Sample Preparation Kit*
Bringing High-Sensitivity ESR1 Mutation Testing to qPCR
ESR1 Mutations are the Leading Cause of Primary Treatment Resistance in HR+ mBC
The ESR1 gene encodes for estrogen receptor alpha (ERα), and mutations in its ligand-binding domain result in constitutive activation of the estrogen receptor, causing overactive downstream signaling. ESR1 mutations have emerged as a key biomarker in determining resistence to therapy in hormone receptor-positive (HR+), metastatic breast cancer (mBC) patients. While these mutations are exceptionally rare in treatment-naïve patients, they are prevalent in up to 40% of mBC patients with prolonged exposure to endocrine therapy (ET) and lead to treatment failure and ultimately, disease progression. Recent and ongoing clinical trials aim to demonstrate that changing therapy at the first appearance of ESR1 mutations results in marked improvements in reduction of disease progression. Emerging novel therapies targeting ESR1-mutant disease offer a promising solution to overcoming this mechanism of primary therapy resistance.
Leveraging Exosomes for a Differentiated Approach
Whereas circulating tumor DNA (ctDNA) is released exclusively from dying cells and is in relatively low abundance, these same cells actively secrete tens of thousands of exosomes daily. Exosomes contain exosomal RNA (exoRNA), which provides a dynamic snapshot of the body’s transcriptome. By co-analyzing exoRNA with ctDNA via liquid biopsy, we can unlock highly sensitive, minimally invasive biomarker detection using established qPCR testing technologies. Utilizing this approach, Asuragen has developed the first, multi-analyte, qPCR-based liquid biopsy assay for the detection of ESR1 mutations from plasma, empowering molecular laboratories to participate in this new frontier of clinical research and push the boundaries of conventional qPCR. The QuantideX qPCR ESR1 exoMutation Kit* is designed to provide highly sensitive detection of 11 of the most prevalent ESR1 variants in plasma, offering a novel approach to achieving more meaningful breast cancer insights.
Learn more about the Power of Exosomes
Streamlining cfDNA + exoRNA Co-Isolation
The QuantideX qPCR ESR1 exoMutation Kit is paired with the ExoLution™ Plus cfDNA + exoRNA Sample Preparation Kit, leveraging proprietary chemistries from Exosome Diagnostics™ to co-isolate cfDNA + exoRNA in a single workflow. ExoLution Plus includes all necessary reagents and consumables for high-quality, multi-analyte isolation to power downstream mutation testing.
Figure 1: Combined Workflow for the QuantideX qPCR ESR1 exoMutation Kit and ExoLution Plus cfDNA and exoRNA Sample Preparation Kit*
Optimizing Data Reporting with Automated Software Feature
The QuantideX qPCR ESR1 exoMutation Kit’s ready-to-use design doesn’t stop at the bench. Our push-button, automated software, created to run on commonly used operating systems, takes the guesswork and hands-on time out of data analysis. The software module is included with the assay and does not require separate purchases or licenses.
Resources
An Exosome-based ESR1 Monitoring RT-qPCR Technology That Rapidly and Accurately Detects Circulating Tumor Acquired Resistance Variants at ≤ 0.1% Frequency in Liquid Biopsy Samples
Product Description
| Category | Description |
|---|---|
| Coverage | 11 ligand-binding domain mutations: E380Q; V422del; S463P; L536H/P/R (X); Y537S/N/C/D (X); D538G |
| Capacity | 50 samples |
| Analyte | ctDNA + exoRNA |
| Sample | 2mL Plasma |
| NA Isolation | ExoLution™ Plus |
| Assay Sensitivity | <0.1% MAF (~5 copies/mL) |
| Workflow | Sample-to-answer in <8 hours |
Interested in becoming an Early Access Site?
Enrollment for early access sites will begin in Spring 2024.
Disclaimer
*For Research Use Only. Not for use in diagnostic procedures
†This product is under development; performance characteristics and final product features to be determined.
- Breast Cancer Res. 2021 Aug 15;23(1):85. 2. Lancet Oncol. 2022 Nov;23(11):1367-1377.
QuantideX® qPCR ESR1 exoMutation Kit*†
ExoLution™ Plus cfDNA + exoRNA Sample Preparation Kit*
Bringing High-Sensitivity ESR1 Mutation Testing to qPCR
ESR1 Mutations are the Leading Cause of Primary Treatment Resistance in HR+ mBC
The ESR1 gene encodes for estrogen receptor alpha (ERα), and mutations in its ligand-binding domain result in constitutive activation of the estrogen receptor, causing overactive downstream signaling. ESR1 mutations have emerged as a key biomarker in determining resistence to therapy in hormone receptor-positive (HR+), metastatic breast cancer (mBC) patients. While these mutations are exceptionally rare in treatment-naïve patients, they are prevalent in up to 40% of mBC patients with prolonged exposure to endocrine therapy (ET) and lead to treatment failure and ultimately, disease progression. Recent and ongoing clinical trials aim to demonstrate that changing therapy at the first appearance of ESR1 mutations results in marked improvements in reduction of disease progression. Emerging novel therapies targeting ESR1-mutant disease offer a promising solution to overcoming this mechanism of primary therapy resistance.
Leveraging Exosomes for a Differentiated Approach
Whereas circulating tumor DNA (ctDNA) is released exclusively from dying cells and is in relatively low abundance, these same cells actively secrete tens of thousands of exosomes daily. Exosomes contain exosomal RNA (exoRNA), which provides a dynamic snapshot of the body’s transcriptome. By co-analyzing exoRNA with ctDNA via liquid biopsy, we can unlock highly sensitive, minimally invasive biomarker detection using established qPCR testing technologies. Utilizing this approach, Asuragen has developed the first, multi-analyte, qPCR-based liquid biopsy assay for the detection of ESR1 mutations from plasma, empowering molecular laboratories to participate in this new frontier of clinical research and push the boundaries of conventional qPCR. The QuantideX qPCR ESR1 exoMutation Kit* is designed to provide highly sensitive detection of 11 of the most prevalent ESR1 variants in plasma, offering a novel approach to achieving more meaningful breast cancer insights.
Learn more about the Power of Exosomes
Streamlining cfDNA + exoRNA Co-Isolation
The QuantideX qPCR ESR1 exoMutation Kit is paired with the ExoLution™ Plus cfDNA + exoRNA Sample Preparation Kit, leveraging proprietary chemistries from Exosome Diagnostics™ to co-isolate cfDNA + exoRNA in a single workflow. ExoLution Plus includes all necessary reagents and consumables for high-quality, multi-analyte isolation to power downstream mutation testing.
Figure 1: Combined Workflow for the QuantideX qPCR ESR1 exoMutation Kit and ExoLution Plus cfDNA and exoRNA Sample Preparation Kit*
Optimizing Data Reporting with Automated Software Feature
The QuantideX qPCR ESR1 exoMutation Kit’s ready-to-use design doesn’t stop at the bench. Our push-button, automated software, created to run on commonly used operating systems, takes the guesswork and hands-on time out of data analysis. The software module is included with the assay and does not require separate purchases or licenses.