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BIO-TECHNE LAUNCHES ESR1 MUTATION MONITORING ASSAY

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Bio-Techne (NASDAQ: TECH) has launched a new ESR1 mutation monitoring assay through its brand Asuragen. The research-use-only assay includes a qPCR detection kit and an isolation kit for cell-free DNA and exosomal RNA. The technology is designed to detect 11 ESR1 ligand-binding domain mutations with high sensitivity, particularly relevant for hormone receptor-positive (HR+) metastatic breast cancer patients.

The assay combines QuantideX® qPCR ESR1 exoMutation Kit with ExoLution™ Plus cfDNA + exoRNA Isolation Kit, offering enhanced sensitivity through detection of both cell-free DNA and exosomal RNA signals. This advancement is significant as ESR1 mutations appear in up to 40% of HR+ metastatic breast cancer patients following endocrine therapy, indicating treatment resistance.

Bio-Techne (NASDAQ: TECH) ha lanciato un nuovo saggio per il monitoraggio delle mutazioni ESR1 attraverso il suo marchio Asuragen. Il saggio, utilizzabile solo per ricerca, include un kit di rilevamento qPCR e un kit di isolamento per DNA libero e RNA esosomal. La tecnologia è progettata per rilevare 11 mutazioni nel dominio di legame del ligando ESR1 con alta sensibilità, particolarmente rilevante per i pazienti con cancro al seno metastatico con recettori ormonali positivi (HR+).

Il saggio unisce il QuantideX® qPCR ESR1 exoMutation Kit con l'ExoLution™ Plus cfDNA + exoRNA Isolation Kit, offrendo una sensibilità migliorata attraverso la rilevazione di segnali sia di DNA libero che di RNA esosomal. Questo progresso è significativo poiché le mutazioni ESR1 si riscontrano in fino al 40% dei pazienti con cancro al seno metastatico HR+ dopo terapia endocrina, indicando resistenza al trattamento.

Bio-Techne (NASDAQ: TECH) ha lanzado un nuevo ensayo para el monitoreo de mutaciones ESR1 a través de su marca Asuragen. El ensayo, diseñado solo para investigación, incluye un kit de detección qPCR y un kit de aislamiento para ADN libre y ARN exosomal. La tecnología está diseñada para detectar 11 mutaciones en el dominio de unión al ligando ESR1 con alta sensibilidad, siendo especialmente relevante para pacientes con cáncer de mama metastásico con receptores hormonales positivos (HR+).

El ensayo combina el QuantideX® qPCR ESR1 exoMutation Kit con el ExoLution™ Plus cfDNA + exoRNA Isolation Kit, ofreciendo una sensibilidad mejorada a través de la detección de señales tanto de ADN libre como de ARN exosomal. Este avance es significativo ya que las mutaciones ESR1 aparecen en hasta el 40% de los pacientes con cáncer de mama metastásico HR+ después de la terapia endocrina, lo que indica resistencia al tratamiento.

Bio-Techne (NASDAQ: TECH)는 Asuragen 브랜드를 통해 새로운 ESR1 변이 모니터링 검사법을 출시했습니다. 이 연구용 검사법은 qPCR 탐지 키트와 세포자유 DNA 및 외소RNA 분리를 위한 키트를 포함하고 있습니다. 이 기술은 호르몬 수용체 양성(HR+) 전이성 유방암 환자에게 특히 관련성이 높은, 높은 감도로 11개의 ESR1 리간드 결합 도메인 변이를 검출하도록 설계되었습니다.

이 검사법은 QuantideX® qPCR ESR1 exoMutation KitExoLution™ Plus cfDNA + exoRNA Isolation Kit를 결합하여 세포자유 DNA와 외소RNA 신호를 모두 검출함으로써 감도를 향상시킵니다. 이 발전은 ESR1 변이가 내분비 치료 후 최대 40%의 HR+ 전이성 유방암 환자에서 나타나며, 이는 치료 저항성을 나타냅니다.

Bio-Techne (NASDAQ: TECH) a lancé un nouvel essai de surveillance des mutations ESR1 à travers sa marque Asuragen. Cet essai, destiné uniquement à la recherche, comprend un kit de détection qPCR et un kit d'isolement pour l'ADN libre et l'ARN exosomal. La technologie est conçue pour détecter 11 mutations dans le domaine de liaison au ligand ESR1 avec une haute sensibilité, particulièrement pertinente pour les patients atteints de cancer du sein métastatique récepteurs hormonaux positifs (HR+).

L'essai combine le QuantideX® qPCR ESR1 exoMutation Kit avec le ExoLution™ Plus cfDNA + exoRNA Isolation Kit, offrant une sensibilité accrue grâce à la détection à la fois de l'ADN libre et des signaux d'ARN exosomal. Cette avancée est significative car les mutations ESR1 apparaissent chez jusqu'à 40 % des patients atteints de cancer du sein métastatique HR+ après une thérapie endocrinienne, indiquant ainsi une résistance au traitement.

Bio-Techne (NASDAQ: TECH) hat einen neuen ESR1-Mutationsüberwachungsassay unter der Marke Asuragen eingeführt. Der nur für Forschungszwecke verwendbare Assay umfasst ein qPCR-Nachweiskit sowie ein Isolationskit für zellfreies DNA und exosomales RNA. Die Technologie wurde entwickelt, um 11 Mutationen im Ligandbindungsdomäne von ESR1 mit hoher Sensitivität zu detektieren, was insbesondere für Patienten mit hormonrezeptorpositivem (HR+) metastasierten Brustkrebs relevant ist.

Der Assay kombiniert das QuantideX® qPCR ESR1 exoMutation Kit mit dem ExoLution™ Plus cfDNA + exoRNA Isolation Kit und bietet durch die Detektion von sowohl zellfreier DNA als auch exosomalem RNA-Signalen eine verbesserte Sensitivität. Dieser Fortschritt ist bedeutend, da ESR1-Mutationen in bis zu 40% der HR+ metastasierten Brustkrebspatienten nach einer endokrinen Therapie auftreten und damit auf eine Behandlungsresistenz hinweisen.

Positive
  • Developed highly sensitive assay capable of detecting 11 ESR1 mutations
  • Compatible with widely available qPCR technology, reducing implementation costs
  • Achieves superior sensitivity through dual detection of cell-free DNA and exosomal RNA
Negative
  • Product to research use only, not approved for diagnostic procedures

Insights

The launch of Bio-Techne's ESR1 mutation monitoring assay represents a significant advancement in breast cancer research diagnostics. The technology combines qPCR detection with isolation capabilities for both cell-free DNA and exosomal RNA, enabling detection of 11 ESR1 ligand-binding domain mutations with enhanced sensitivity. The 40% mutation rate in HR+ metastatic breast cancer patients post-endocrine therapy underscores the clinical significance. This assay's compatibility with existing qPCR platforms offers cost-effective implementation without requiring new infrastructure investments. The dual detection approach (cfDNA + exoRNA) achieves superior sensitivity compared to conventional methods, potentially accelerating treatment resistance identification and improving patient outcomes through earlier intervention.

This product launch strengthens Bio-Techne's position in the precision oncology diagnostics market. The timing aligns with increasing clinical trials for ESR1-targeted therapies, creating potential market expansion opportunities. The assay's compatibility with widely-available qPCR technology reduces barriers to adoption and positions it competitively against more expensive alternatives. While currently to research use only, the technology platform could eventually support diagnostic applications, representing future growth potential. The focus on breast cancer, a major oncology segment and the ability to monitor treatment resistance provides a clear value proposition for research laboratories and pharmaceutical companies conducting clinical trials.

Company will showcase new assay at the upcoming San Antonio Breast Cancer Symposium

MINNEAPOLIS, Dec. 10, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that Asuragen, a Bio-Techne brand, launched a highly sensitive ESR1 mutation monitoring assay. ESR1 gene mutations are known to be linked to hormone receptor-positive (HR+) metastatic breast cancer. The research-use-only assay, which consists of a qPCR detection kit as well as an isolation kit for cell-free DNA and exosomal RNA, will be featured in the Asuragen booth (#1429) at the San Antonio Breast Cancer Symposium beginning on December 10th.

While mutations in the ESR1 gene are exceedingly rare in cancer patients prior to treatment, the use of endocrine therapies leads to the emergence of ESR1 mutations in as many as 40% of patients with HR+ metastatic breast cancer. Identifying these mutations as quickly as possible is crucial for clinicians to spot the early warning signs of treatment resistance and adjust course as appropriate. Unfortunately, most molecular testing technologies lack the sensitivity needed to reliably and cost-effectively detect these mutations.

Asuragen's new ESR1 mutation assay, which consists of the QuantideX® qPCR ESR1 exoMutation Kit paired with the ExoLution™ Plus cfDNA + exoRNA Isolation Kit, was designed to detect 11 ESR1 ligand-binding domain mutations in samples at very high sensitivity. It can be used with widely available qPCR technology for easy implementation without the added cost of adopting a new platform. By detecting the molecular signal from both cell-free DNA and exosomal RNA, the assay achieves sensitivity levels that were previously only attainable with much more expensive, cumbersome, or lower plex technologies.

"With a growing number of candidate drugs targeting ESR1 mutations in clinical trials, it is more important than ever for laboratory scientists to be able to spot the emergence of these mutations among individuals who have been treated with aromatase inhibitors and other endocrine therapies," said Dr. Matt McManus, President of Bio-Techne's Diagnostics and Spatial Biology Segment. "Pairing our deep expertise in developing highly sensitive, qPCR-based assays with our capabilities in extracting data from exosomes, puts Bio-Techne in a unique position to provide a high-quality, streamlined, and multiplexed ESR1 mutation assay for broad use in clinical research laboratories."

For more product information, please visit https://asuragen.com/portfolio/oncology/quantidex-esr1-exomutation-kit/.

Asuragen's ESR1 mutation assay is intended for research use only and is not meant for use in diagnostic procedures.

About Bio-Techne

Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With hundreds of thousands of products in its portfolio, Bio-Techne generated approximately $1.2 billion in net sales in fiscal 2024 and has approximately 3,100 employees worldwide. For more information on Bio-Techne and its brands, please visit http://www.bio-techne.com or follow the Company on social media at Facebook, LinkedIn, Twitter or YouTube.

About Bio-Techne Corporation (NASDAQ: TECH)
Contact: David Clair, Vice President, Investor Relations & Corporate Development
david.clair@bio-techne.com
612-656-4416

BT Logo (PRNewsfoto/Bio-Techne Corporation)

 

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SOURCE Bio-Techne Corporation

FAQ

What is the new ESR1 mutation monitoring assay launched by Bio-Techne (TECH)?

Bio-Techne launched a highly sensitive research-use-only assay combining QuantideX® qPCR ESR1 exoMutation Kit and ExoLution™ Plus cfDNA + exoRNA Isolation Kit to detect ESR1 mutations in breast cancer patients.

How many ESR1 mutations can Bio-Techne's (TECH) new assay detect?

The assay can detect 11 ESR1 ligand-binding domain mutations with high sensitivity.

What percentage of HR+ metastatic breast cancer patients develop ESR1 mutations after endocrine therapy according to Bio-Techne (TECH)?

According to Bio-Techne, up to 40% of patients with HR+ metastatic breast cancer develop ESR1 mutations following endocrine therapy.

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