BIO-TECHNE LAUNCHES ESR1 MUTATION MONITORING ASSAY

Rhea-AI Summary

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.

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

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 10^th.

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

 

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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.