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src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_700,h_300/https://asuragen.com/wp-content/uploads/2023/11/asu-esr1-exosome-header-700x300-1.png" alt="esr1 gene and exosome" width="700" height="300" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_700/https://asuragen.com/wp-content/uploads/2023/11/asu-esr1-exosome-header-700x300-1.png 700w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2023/11/asu-esr1-exosome-header-700x300-1-300x129.png 300w" sizes="auto, (max-width: 700px) 100vw, 700px" /></p> <p><a class="btn -icon -underline" href="#request" rel="noopener">Request More Information</a></p> <p><a class="btn -icon -underline" href="#posters" rel="noopener">View Scientific Posters</a></p> <h2>Bringing High-Sensitivity <i>ESR1</i> Mutation Testing to qPCR</h2> <p>The Quantidex qPCR <em>ESR1</em> exoMutation Kit is the first multi-analyte liquid biopsy assay tailored for detecting <em>ESR1</em> mutations. Designed to provide highly sensitive detection in 11 of the most prevalent <em>ESR1</em> variants in plasma, the kit offers a novel approach to achieving more meaningful breast cancer insights.</p> <p><strong>Streamlining cfDNA + exoRNA Co-Isolation</strong></p> <p>The QuantideX qPCR <em>ESR1</em> exoMutation Kit is paired with the ExoLution Plus cfDNA + exoRNA Isolation Kit, leveraging proprietary chemistries 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.</p> <p><img loading="lazy" decoding="async" class="alignnone size-large wp-image-195473" src="https://origin.asuragen.com/wp-content/uploads/2024/10/quantidex_esr1-mutation-kit-workflow-1024x274.png" alt="quantidex esr1 mutation kit workflow" width="1024" height="274" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2024/10/quantidex_esr1-mutation-kit-workflow-1024x274.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2024/10/quantidex_esr1-mutation-kit-workflow-300x80.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2024/10/quantidex_esr1-mutation-kit-workflow-768x205.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1536/https://asuragen.com/wp-content/uploads/2024/10/quantidex_esr1-mutation-kit-workflow-1536x410.png 1536w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2048/https://asuragen.com/wp-content/uploads/2024/10/quantidex_esr1-mutation-kit-workflow-2048x547.png 2048w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></p> <p><b>Figure 1: </b>Combined Workflow for the QuantideX qPCR <em>ESR1</em> exoMutation Kit and ExoLution Plus cfDNA and exoRNA Isolation Kit*</p> <p> </p> <p><b>Leveraging Exosomes for a Differentiated Approach</b></p> <p>Whereas cell-free DNA (cfDNA) 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 cfDNA 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 <i>ESR1</i> 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 <i>ESR1</i> exoMutation Kit* is designed to provide highly sensitive detection of 11 of the most prevalent <i>ESR1</i> variants in plasma, offering a novel approach to achieving more meaningful breast cancer insights.</p> <p> </p> <div style="width: 3840px;" class="wp-video"> <video class="wp-video-shortcode" id="video-194633-1" width="3840" height="2160" preload="metadata" controls="controls"><source type="video/mp4" src="https://asuragen.com/wp-content/uploads/2024/04/esr1-mutation-testing-video.mp4?_=1" /><a href="https://asuragen.com/wp-content/uploads/2024/04/esr1-mutation-testing-video.mp4">https://asuragen.com/wp-content/uploads/2024/04/esr1-mutation-testing-video.mp4</a></video></div> <p> </p> <p><b>Optimizing Data Reporting with Automated Software Feature</b></p> <p>The QuantideX qPCR <i>ESR1</i> 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.</p> <p><a class="btn -icon -underline" href="https://asuragen.com/wp-content/uploads/2024/12/quantidex-qpcr-esr1-exomutation-kit-brochure.pdf" target="_blank" rel="noopener">Download the brochure</a></p> <p><strong>Limit of Detection Demonstrates High Sensitivity</strong></p> <p>Probit analysis of synthetic DNA (0, 1, 3, 5, 10 copies/rxn, 20 replicates of each) titrated in a background of presumed normal DNA (10,000 total copies)</p> <p><img loading="lazy" decoding="async" class="alignnone wp-image-195525" src="https://origin.asuragen.com/wp-content/uploads/2024/11/lod-sensitivity-comparison-synthetic-dna-probit-analysis-1024x781.png" alt="limit of detection sensitivity comparison synthetic dna analysis" width="638" height="486" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2024/11/lod-sensitivity-comparison-synthetic-dna-probit-analysis-1024x781.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2024/11/lod-sensitivity-comparison-synthetic-dna-probit-analysis-300x229.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2024/11/lod-sensitivity-comparison-synthetic-dna-probit-analysis-768x586.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1532/https://asuragen.com/wp-content/uploads/2024/11/lod-sensitivity-comparison-synthetic-dna-probit-analysis.png 1532w" sizes="auto, (max-width: 638px) 100vw, 638px" /></p> <table id="tablepress-9" class="tablepress tablepress-id-9"> <thead> <tr class="row-1"> <th class="column-1">Target</th><th class="column-2">LOD (%VAF)*<br /> </th> </tr> </thead> <tbody class="row-striping row-hover"> <tr class="row-2"> <td class="column-1">D538G</td><td class="column-2">0.082%</td> </tr> <tr class="row-3"> <td class="column-1">S463P</td><td class="column-2">0.066%</td> </tr> <tr class="row-4"> <td class="column-1">Y537S</td><td class="column-2">0.025%</td> </tr> <tr class="row-5"> <td class="column-1">Y537C</td><td class="column-2">0.028%</td> </tr> <tr class="row-6"> <td class="column-1">Y537N</td><td class="column-2">0.025%</td> </tr> <tr class="row-7"> <td class="column-1">Y537D</td><td class="column-2">0.030%</td> </tr> <tr class="row-8"> <td class="column-1">E380Q</td><td class="column-2">0.028%</td> </tr> <tr class="row-9"> <td class="column-1">L536R</td><td class="column-2">0.028%</td> </tr> <tr class="row-10"> <td class="column-1">L536H</td><td class="column-2">0.041%</td> </tr> <tr class="row-11"> <td class="column-1">L536P</td><td class="column-2">0.028%</td> </tr> <tr class="row-12"> <td class="column-1">V422del</td><td class="column-2">0.030%</td> </tr> </tbody> </table>  <p><b>High Analytical Specificity Observed Across Both K<sub>2</sub>EDTA, PAXgene Tubes</b></p> <p>Evaluation of target analytical specificity (exclusivity) was determined on plasma procured from presumed normal samples</p> <p style="text-align: center;"> <table id="tablepress-8" class="tablepress tablepress-id-8"> <thead> <tr class="row-1"> <th class="column-1"><center>Blood Collection Tube</center></th><th class="column-2"><center>Specificity based on Negative Percent Agreement (NPA)</center></th> </tr> </thead> <tbody class="row-striping row-hover"> <tr class="row-2"> <td class="column-1"><center>K<sub>2</sub>EDTA</center></td><td class="column-2"><center>97.1%</center></td> </tr> <tr class="row-3"> <td class="column-1"><center>PAXgene Blood cfDNA Tube</center></td><td class="column-2"><center>97.7%</center></td> </tr> </tbody> </table> </p> <ul> <li>Utilized ExoLution Plus cfDNA + exoRNA Isolation Kit* workflow for nucleic acid isolation</li> <li>Support of multiple collection tubes provides more flexibility to accommodate nuances across laboratory operations</li> </ul> <p><strong>Software Enables Comprehensive, Push-Button Analysis and QC</strong></p> <p><img loading="lazy" decoding="async" class="alignnone size-large wp-image-195536" src="https://origin.asuragen.com/wp-content/uploads/2024/11/esr1-software-1024x575.png" alt="esr1 mutation kit software" width="1024" height="575" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2024/11/esr1-software-1024x575.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2024/11/esr1-software-300x168.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2024/11/esr1-software-768x431.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1536/https://asuragen.com/wp-content/uploads/2024/11/esr1-software-1536x862.png 1536w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2048/https://asuragen.com/wp-content/uploads/2024/11/esr1-software-2048x1149.png 2048w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></p> <p>QuantideX qPCR <em>ESR1</em> exoMutation Analysis Module</p> <ul> <li>Automated variant calling</li> <li>Batch Control QCs</li> <li>Click on the “+” on the left side of table to drill down to Ct (Cq) values</li> <li>Export results in LIMS-compatible format (CSV)</li> </ul> <p><b><i>ESR1</i></b><b> Mutations are the Leading Cause of Primary Treatment Resistance in HR+ </b><b>mBC</b></p> <p>The <i>ESR1</i> 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. <i>ESR1</i> mutations have emerged as a key biomarker in determining resistance 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 <i>ESR1</i> mutations results in marked improvements in reduction of disease progression. Emerging novel therapies targeting <i>ESR1</i>-mutant disease offer a promising solution to overcoming this mechanism of primary therapy resistance.</p> <nav class="solutions-nav stacked"> <a href="#us-1">Resources</a> <a href="#us-3">Product Description</a> <a href="#us-4">Contact Us</a> <a href="#us-5">Disclaimer</a> </nav> <div id="us-1" class="solutions-detail-content"> <h3 class="solution-subtitle">Resources</h3> <p><a href="https://info.bio-techne.com/amp-2024-esr1-workshop.html">Watch the Workshop: ESR1 & Beyond: Leveraging Exosomes for Highly-Sensitive Variant Detection on qPCR</a> | Presented at the Association for Molecular Pathology Annual Meeting 2024</p> <p><a href="https://asuragen.com/wp-content/uploads/2024/12/oncology-verification-cell-free-dna-exosomal-rna-assay-esr1-mutations.pdf">SABCS Poster: Verification of a Highly Sensitive, Circulating Cell-Free DNA and Exosomal RNA RT-qPCR Assay System to Monitor <em>ESR1 </em>Mutations from a Liquid Biopsy</a> | Kevin Kelnar, Blaine Caughron, Holli Dale….SABCS 2024</p> <p><a href="https://asuragen.com/wp-content/uploads/2024/11/genetics-liquid-biopsy-surveillance-treatment-resistant-esr1-mutations-amp-2024.pdf">View the Poster: Verification of an RT-qPCR Assay System for Liquid Biopsy Surveillance of Treatment-Resistant ESR1 Mutations</a> | Presented at the Association for Molecular Pathology Annual Meeting & Expo 2024</p> <p><a href="https://info.bio-techne.com/ESR1WhitePaper.html">View the Whitepaper: With Exosome Analysis, Highly Sensitive Monitoring of <em>ESR1</em> Mutations is Possible</a></p> <p><a href="https://www.bio-techne.com/diagnostics/exosome" target="_blank" rel="noopener">Learn more about the Power of Exosomes</a></p> <p><a href="https://www.bio-techne.com/resources/literature/cfdna-harnessing-power-of-exosomes" target="_blank" rel="noopener">Learn more about the Exosome Platforms capabilities for Cancer Mutation Detection</a></p> <p id="posters">Other Scientific Posters</p> <p><a href="https://asuragen.com/wp-content/uploads/2024/09/oncology-exosome-based-esr1-monitoring-esmo-2024.pdf">An Exosome-based <em>ESR1 </em>Monitoring RT-qPCR Kit That Rapidly and Accurately Detects Acquired Resistance Variants at ≤ 0.1% Frequency in Liquid Biopsy Samples</a> | Sarah Statt, Julie R Thibert, Melissa Church, Jamie Myers1, Holli Dale, Blaine Caughron, Kevin Kelnar, and Brian Haynes</p> <p><a href="https://asuragen.com/wp-content/uploads/2023/11/oncology-exosome-based-detection-ct-acquired-resistance-variants-esr1-amp-2023.pdf">Development of a Novel Exosome-based, Multiplexed RT-qPCR Technology for Rapid and Accurate Detection of Circulating Tumor Acquired Resistance Variants in <em>ESR1</em> at ≤ 0.1% Frequency</a> | Julie R Thibert, Sarah Statt, Liangjing Chen, Melissa Church… AMP 2023</p> <p><a href="https://asuragen.com/wp-content/uploads/2023/04/oncology-exosome-based-esr1-monitoring-aacr-2023.pdf">An Exosome-based <em>ESR1</em> Monitoring RT-qPCR Technology That Rapidly and Accurately Detects Circulating Tumor Acquired Resistance Variants at ≤ 0.1% Frequency in Liquid Biopsy Samples</a> | Sarah Statt, Julie R. Thibert, Liangjing Chen… AACR 2023</p> <p><a href="https://asuragen.com/wp-content/uploads/2024/12/oncology-amp-2024-leveraging-exosomes-highly-sensitive-variant-detection.pdf">AMP 2024 Workshop Slides: <em>ESR1 </em>& Beyond: Leveraging Exosomes for Highly – Sensitive Variant Detection on qPCR</a></p> </div> <div id="us-3" class="solutions-detail-content"> <h3 class="solution-subtitle">Product Description</h3> <table id="tablepress-6" class="tablepress tablepress-id-6"> <thead> <tr class="row-1"> <th class="column-1">Category</th><th class="column-2">Description</th> </tr> </thead> <tbody class="row-striping row-hover"> <tr class="row-2"> <td class="column-1">Coverage</td><td class="column-2">11 ligand-binding domain mutations: E380Q; V422del; S463P; L536H/P/R (X); Y537S/N/C/D (X); D538G<br /> </td> </tr> <tr class="row-3"> <td class="column-1">Capacity</td><td class="column-2">50 samples</td> </tr> <tr class="row-4"> <td class="column-1">Analyte</td><td class="column-2">cfDNA + exoRNA</td> </tr> <tr class="row-5"> <td class="column-1">Sample</td><td class="column-2">2mL Plasma</td> </tr> <tr class="row-6"> <td class="column-1">NA Isolation</td><td class="column-2">ExoLution™ Plus<br /> </td> </tr> <tr class="row-7"> <td class="column-1">Assay Sensitivity</td><td class="column-2">0.03-0.08% VAF (~5 copies/mL)</td> </tr> <tr class="row-8"> <td class="column-1">Workflow</td><td class="column-2">Sample-to-answer in <8 hours</td> </tr> <tr class="row-9"> <td class="column-1">Within Sample Control (IC1, IC2 & IC3)</td><td class="column-2">An <b>Internal Control (IC)</b> is included in all 3 mixes (A, B & C)<br /> Because we don’t require users to quantitate their qPCR input, the IC informs the user if they have added adequate sample into each of the testing wells</td> </tr> <tr class="row-10"> <td class="column-1">Batch Controls</td><td class="column-2">The <b>Positive Control (CONP)</b> is a DNA based control for 6 of the 11 targeted mutations Each mix contains 2 mutations as a positive control. <br /> <ul><br /> <li>Mix A: D538G & S463P</li> <br /> <li>Mix B: Y537X & E380Q</li><br /> <li>Mix C: L536X & V422del</li><br /> </ul>The Positive Control demonstrates successful qPCR via positive signal in all 3 mixes across 2 mutant channels<br /> </td> </tr> <tr class="row-11"> <td class="column-1">Batch Controls</td><td class="column-2">The <b>Negative Control (CONN)</b> is an RNA based negative control. It acts as:<br /> <ul><br /> <li>A batch contamination control and</li><br /> <li>Demonstrates a successful Reverse Transcriptase (RT) reaction within the RT-qPCR workflow via positive signal in all 3 mixes in the internal control channel</li><br /> </ul></td> </tr> </tbody> </table>  <p> </p> </div> <div id="us-4" class="solutions-detail-content"> <h3 class="solution-subtitle">Contact Us</h3> <p id="request">Contact us to learn more about the QuantideX qPCR <em>ESR1</em> ExoMutation Kit</p> <p><script src="https://info.bio-techne.com/js/forms2/js/forms2.min.js"></script></p> <form id="mktoForm_10857"></form> <p><script>MktoForms2.loadForm("//info.bio-techne.com", "584-XSF-168", 10857);</script></p> </div> <div id="us-5" class="solutions-detail-content"> <h3 class="solution-subtitle">Disclaimer</h3> <p>*For Research Use Only. Not for use in diagnostic procedures</p> <ol> <li>Breast Cancer Res. 2021 Aug 15;23(1):85. 2. Lancet Oncol. 2022 Nov;23(11):1367-1377.</li> </ol> </div> </div> <div class="solution-description" id="solution-non-us"> <h1>QuantideX<sup>®</sup> qPCR <em>ESR1</em> exoMutation Kit*<br> ExoLution™ Plus cfDNA + exoRNA Isolation Kit*</h1> <p><img loading="lazy" decoding="async" class="alignnone size-full wp-image-194708" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_700,h_300/https://asuragen.com/wp-content/uploads/2023/11/asu-esr1-exosome-header-700x300-1.png" alt="esr1 gene and exosome" width="700" height="300" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_700/https://asuragen.com/wp-content/uploads/2023/11/asu-esr1-exosome-header-700x300-1.png 700w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2023/11/asu-esr1-exosome-header-700x300-1-300x129.png 300w" sizes="auto, (max-width: 700px) 100vw, 700px" /></p> <p><a class="btn -icon -underline" href="#request" rel="noopener">Request More Information</a></p> <p><a class="btn -icon -underline" href="#posters" rel="noopener">View Scientific Posters</a></p> <h2>Bringing High-Sensitivity <i>ESR1</i> Mutation Testing to qPCR</h2> <p>The Quantidex qPCR <em>ESR1</em> exoMutation Kit is the first multi-analyte liquid biopsy assay tailored for detecting <em>ESR1</em> mutations. Designed to provide highly sensitive detection in 11 of the most prevalent <em>ESR1</em> variants in plasma, the kit offers a novel approach to achieving more meaningful breast cancer insights.</p> <p><strong>Streamlining cfDNA + exoRNA Co-Isolation</strong></p> <p>The QuantideX qPCR <em>ESR1</em> exoMutation Kit is paired with the ExoLution Plus cfDNA + exoRNA Isolation Kit, leveraging proprietary chemistries 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.</p> <p><img loading="lazy" decoding="async" class="alignnone size-large wp-image-195473" src="https://origin.asuragen.com/wp-content/uploads/2024/10/quantidex_esr1-mutation-kit-workflow-1024x274.png" alt="quantidex esr1 mutation kit workflow" width="1024" height="274" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2024/10/quantidex_esr1-mutation-kit-workflow-1024x274.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2024/10/quantidex_esr1-mutation-kit-workflow-300x80.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2024/10/quantidex_esr1-mutation-kit-workflow-768x205.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1536/https://asuragen.com/wp-content/uploads/2024/10/quantidex_esr1-mutation-kit-workflow-1536x410.png 1536w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2048/https://asuragen.com/wp-content/uploads/2024/10/quantidex_esr1-mutation-kit-workflow-2048x547.png 2048w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></p> <p><b>Figure 1: </b>Combined Workflow for the QuantideX qPCR <em>ESR1</em> exoMutation Kit and ExoLution Plus cfDNA and exoRNA Isolation Kit*</p> <p> </p> <p><b>Leveraging Exosomes for a Differentiated Approach</b></p> <p>Whereas cell-free DNA (cfDNA) 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 cfDNA 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 <i>ESR1</i> 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 <i>ESR1</i> exoMutation Kit* is designed to provide highly sensitive detection of 11 of the most prevalent <i>ESR1</i> variants in plasma, offering a novel approach to achieving more meaningful breast cancer insights.</p> <p> </p> <div style="width: 3840px;" class="wp-video"><video class="wp-video-shortcode" id="video-194633-2" width="3840" height="2160" preload="metadata" controls="controls"><source type="video/mp4" src="https://asuragen.com/wp-content/uploads/2024/04/esr1-mutation-testing-video.mp4?_=2" /><a href="https://asuragen.com/wp-content/uploads/2024/04/esr1-mutation-testing-video.mp4">https://asuragen.com/wp-content/uploads/2024/04/esr1-mutation-testing-video.mp4</a></video></div> <p> </p> <p><b>Optimizing Data Reporting with Automated Software Feature</b></p> <p>The QuantideX qPCR <i>ESR1</i> 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.</p> <p><a class="btn -icon -underline" href="https://asuragen.com/wp-content/uploads/2024/12/quantidex-qpcr-esr1-exomutation-kit-brochure.pdf" target="_blank" rel="noopener">Download the brochure</a></p> <p><strong>Limit of Detection Demonstrates High Sensitivity</strong></p> <p>Probit analysis of synthetic DNA (0, 1, 3, 5, 10 copies/rxn, 20 replicates of each) titrated in a background of presumed normal DNA (10,000 total copies)</p> <p><img loading="lazy" decoding="async" class="alignnone wp-image-195525" src="https://origin.asuragen.com/wp-content/uploads/2024/11/lod-sensitivity-comparison-synthetic-dna-probit-analysis-1024x781.png" alt="limit of detection sensitivity comparison synthetic dna analysis" width="638" height="486" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2024/11/lod-sensitivity-comparison-synthetic-dna-probit-analysis-1024x781.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2024/11/lod-sensitivity-comparison-synthetic-dna-probit-analysis-300x229.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2024/11/lod-sensitivity-comparison-synthetic-dna-probit-analysis-768x586.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1532/https://asuragen.com/wp-content/uploads/2024/11/lod-sensitivity-comparison-synthetic-dna-probit-analysis.png 1532w" sizes="auto, (max-width: 638px) 100vw, 638px" /></p> <table id="tablepress-9-no-2" class="tablepress tablepress-id-9"> <thead> <tr class="row-1"> <th class="column-1">Target</th><th class="column-2">LOD (%VAF)*<br /> </th> </tr> </thead> <tbody class="row-striping row-hover"> <tr class="row-2"> <td class="column-1">D538G</td><td class="column-2">0.082%</td> </tr> <tr class="row-3"> <td class="column-1">S463P</td><td class="column-2">0.066%</td> </tr> <tr class="row-4"> <td class="column-1">Y537S</td><td class="column-2">0.025%</td> </tr> <tr class="row-5"> <td class="column-1">Y537C</td><td class="column-2">0.028%</td> </tr> <tr class="row-6"> <td class="column-1">Y537N</td><td class="column-2">0.025%</td> </tr> <tr class="row-7"> <td class="column-1">Y537D</td><td class="column-2">0.030%</td> </tr> <tr class="row-8"> <td class="column-1">E380Q</td><td class="column-2">0.028%</td> </tr> <tr class="row-9"> <td class="column-1">L536R</td><td class="column-2">0.028%</td> </tr> <tr class="row-10"> <td class="column-1">L536H</td><td class="column-2">0.041%</td> </tr> <tr class="row-11"> <td class="column-1">L536P</td><td class="column-2">0.028%</td> </tr> <tr class="row-12"> <td class="column-1">V422del</td><td class="column-2">0.030%</td> </tr> </tbody> </table>  <p><b>High Analytical Specificity Observed Across Both K<sub>2</sub>EDTA, PAXgene Tubes</b></p> <p>Evaluation of target analytical specificity (exclusivity) was determined on plasma procured from presumed normal samples</p> <p style="text-align: center;"> <table id="tablepress-8-no-2" class="tablepress tablepress-id-8"> <thead> <tr class="row-1"> <th class="column-1"><center>Blood Collection Tube</center></th><th class="column-2"><center>Specificity based on Negative Percent Agreement (NPA)</center></th> </tr> </thead> <tbody class="row-striping row-hover"> <tr class="row-2"> <td class="column-1"><center>K<sub>2</sub>EDTA</center></td><td class="column-2"><center>97.1%</center></td> </tr> <tr class="row-3"> <td class="column-1"><center>PAXgene Blood cfDNA Tube</center></td><td class="column-2"><center>97.7%</center></td> </tr> </tbody> </table> </p> <ul> <li>Utilized ExoLution Plus cfDNA + exoRNA Isolation Kit* workflow for nucleic acid isolation</li> <li>Support of multiple collection tubes provides more flexibility to accommodate nuances across laboratory operations</li> </ul> <p><strong>Software Enables Comprehensive, Push-Button Analysis and QC</strong></p> <p><img loading="lazy" decoding="async" class="alignnone size-large wp-image-195536" src="https://origin.asuragen.com/wp-content/uploads/2024/11/esr1-software-1024x575.png" alt="esr1 mutation kit software" width="1024" height="575" srcset="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1024/https://asuragen.com/wp-content/uploads/2024/11/esr1-software-1024x575.png 1024w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_300/https://asuragen.com/wp-content/uploads/2024/11/esr1-software-300x168.png 300w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_768/https://asuragen.com/wp-content/uploads/2024/11/esr1-software-768x431.png 768w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_1536/https://asuragen.com/wp-content/uploads/2024/11/esr1-software-1536x862.png 1536w, https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img,w_2048/https://asuragen.com/wp-content/uploads/2024/11/esr1-software-2048x1149.png 2048w" sizes="auto, (max-width: 1024px) 100vw, 1024px" /></p> <p>QuantideX qPCR <em>ESR1</em> exoMutation Analysis Module</p> <ul> <li>Automated variant calling</li> <li>Batch Control QCs</li> <li>Click on the “+” on the left side of table to drill down to Ct (Cq) values</li> <li>Export results in LIMS-compatible format (CSV)</li> </ul> <p><b><i>ESR1</i></b><b> Mutations are the Leading Cause of Primary Treatment Resistance in HR+ </b><b>mBC</b></p> <p>The <i>ESR1</i> 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. <i>ESR1</i> mutations have emerged as a key biomarker in determining resistance 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 <i>ESR1</i> mutations results in marked improvements in reduction of disease progression. Emerging novel therapies targeting <i>ESR1</i>-mutant disease offer a promising solution to overcoming this mechanism of primary therapy resistance.</p> <nav class="solutions-nav"> <a href="#non-us-1">Resources</a> <a href="#non-us-2">Videos</a> <a href="#non-us-3">Product Description</a> </nav> <div id="non-us-1" class="solutions-detail-content"> <h3 class="solution-subtitle">Resources</h3> <p><a href="https://info.bio-techne.com/amp-2024-esr1-workshop.html">Watch the Workshop: ESR1 & Beyond: Leveraging Exosomes for Highly-Sensitive Variant Detection on qPCR</a> | Presented at the Association for Molecular Pathology Annual Meeting 2024</p> <p><a href="https://asuragen.com/wp-content/uploads/2024/12/oncology-verification-cell-free-dna-exosomal-rna-assay-esr1-mutations.pdf">SABCS Poster: Verification of a Highly Sensitive, Circulating Cell-Free DNA and Exosomal RNA RT-qPCR Assay System to Monitor <em>ESR1 </em>Mutations from a Liquid Biopsy</a> | Kevin Kelnar, Blaine Caughron, Holli Dale….SABCS 2024</p> <p><a href="https://asuragen.com/wp-content/uploads/2024/11/genetics-liquid-biopsy-surveillance-treatment-resistant-esr1-mutations-amp-2024.pdf">View the Poster: Verification of an RT-qPCR Assay System for Liquid Biopsy Surveillance of Treatment-Resistant ESR1 Mutations</a> | Presented at the Association for Molecular Pathology Annual Meeting & Expo 2024</p> <p><a href="https://info.bio-techne.com/ESR1WhitePaper.html">View the Whitepaper: With Exosome Analysis, Highly Sensitive Monitoring of <em>ESR1</em> Mutations is Possible</a></p> <p><a href="https://www.bio-techne.com/diagnostics/exosome" target="_blank" rel="noopener">Learn more about the Power of Exosomes</a></p> <p><a href="https://www.bio-techne.com/resources/literature/cfdna-harnessing-power-of-exosomes" target="_blank" rel="noopener">Learn more about the Exosome Platforms capabilities for Cancer Mutation Detection</a></p> <p id="resources">Scientific Posters</p> <p><a href="https://asuragen.com/wp-content/uploads/2023/11/oncology-exosome-based-detection-ct-acquired-resistance-variants-esr1-amp-2023.pdf">Development of a Novel Exosome-based, Multiplexed RT-qPCR Technology for Rapid and Accurate Detection of Circulating Tumor Acquired Resistance Variants in <em>ESR1</em> at ≤ 0.1% Frequency</a> | Julie R Thibert, Sarah Statt, Liangjing Chen, Melissa Church… AMP 2023</p> <p><a href="https://asuragen.com/wp-content/uploads/2023/04/oncology-exosome-based-esr1-monitoring-aacr-2023.pdf">An Exosome-based <em>ESR1</em> Monitoring RT-qPCR Technology That Rapidly and Accurately Detects Circulating Tumor Acquired Resistance Variants at ≤ 0.1% Frequency in Liquid Biopsy Samples</a> | Sarah Statt, Julie R. Thibert, Liangjing Chen… AACR 2023</p> <p><a href="https://asuragen.com/wp-content/uploads/2024/12/oncology-amp-2024-leveraging-exosomes-highly-sensitive-variant-detection.pdf">AMP 2024 Workshop Slides: <em>ESR1 </em>& Beyond: Leveraging Exosomes for Highly – Sensitive Variant Detection on qPCR</a></p> <p> </p> </div> <div id="non-us-2" class="solutions-detail-content"> <h3 class="solution-subtitle">Videos</h3> <p><a href="https://info.bio-techne.com/PowerofExosomesCancerMutationVideo.html" target="_blank" rel="noopener">Unlocking the Power of Exosomes: Revolutionizing Cancer Mutation Detection</a></p> <p> </p> <p> </p> </div> <div id="non-us-3" class="solutions-detail-content"> <h3 class="solution-subtitle">Product Description</h3> <table id="tablepress-6-no-2" class="tablepress tablepress-id-6"> <thead> <tr class="row-1"> <th class="column-1">Category</th><th class="column-2">Description</th> </tr> </thead> <tbody class="row-striping row-hover"> <tr class="row-2"> <td class="column-1">Coverage</td><td class="column-2">11 ligand-binding domain mutations: E380Q; V422del; S463P; L536H/P/R (X); Y537S/N/C/D (X); D538G<br /> </td> </tr> <tr class="row-3"> <td class="column-1">Capacity</td><td class="column-2">50 samples</td> </tr> <tr class="row-4"> <td class="column-1">Analyte</td><td class="column-2">cfDNA + exoRNA</td> </tr> <tr class="row-5"> <td class="column-1">Sample</td><td class="column-2">2mL Plasma</td> </tr> <tr class="row-6"> <td class="column-1">NA Isolation</td><td class="column-2">ExoLution™ Plus<br /> </td> </tr> <tr class="row-7"> <td class="column-1">Assay Sensitivity</td><td class="column-2">0.03-0.08% VAF (~5 copies/mL)</td> </tr> <tr class="row-8"> <td class="column-1">Workflow</td><td class="column-2">Sample-to-answer in <8 hours</td> </tr> <tr class="row-9"> <td class="column-1">Within Sample Control (IC1, IC2 & IC3)</td><td class="column-2">An <b>Internal Control (IC)</b> is included in all 3 mixes (A, B & C)<br /> Because we don’t require users to quantitate their qPCR input, the IC informs the user if they have added adequate sample into each of the testing wells</td> </tr> <tr class="row-10"> <td class="column-1">Batch Controls</td><td class="column-2">The <b>Positive Control (CONP)</b> is a DNA based control for 6 of the 11 targeted mutations Each mix contains 2 mutations as a positive control. <br /> <ul><br /> <li>Mix A: D538G & S463P</li> <br /> <li>Mix B: Y537X & E380Q</li><br /> <li>Mix C: L536X & V422del</li><br /> </ul>The Positive Control demonstrates successful qPCR via positive signal in all 3 mixes across 2 mutant channels<br /> </td> </tr> <tr class="row-11"> <td class="column-1">Batch Controls</td><td class="column-2">The <b>Negative Control (CONN)</b> is an RNA based negative control. It acts as:<br /> <ul><br /> <li>A batch contamination control and</li><br /> <li>Demonstrates a successful Reverse Transcriptase (RT) reaction within the RT-qPCR workflow via positive signal in all 3 mixes in the internal control channel</li><br /> </ul></td> </tr> </tbody> </table>  <p> </p> </div> </div> </div> </div> <div class="sidebar"> <div class="sidenav"> <h4>Asuragen Oncology</h4> <div class="solutions-image"> <img decoding="async" src="https://sp-ao.shortpixel.ai/client/to_webp,q_glossy,ret_img/https://asuragen.com/wp-content/uploads/2023/10/quantidex-logo-updated-500x250-1-290x0-c-default.png" alt="QuantideX<sup>®</sup> qPCR <em>ESR1</em> exoMutation Kit*<br> ExoLution™ Plus cfDNA + exoRNA Isolation Kit* Logo" /> </div> <nav> <div class="menu-asuragen-oncology-container"><ul id="menu-asuragen-oncology" class="menu"><li id="menu-item-642" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-642"><a 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