Bio-Techne Launches ESR1 Mutation Monitoring Assay: Stock to Gain?

Bio-Techne Corp. TECH has launched a highly sensitive ESR1 mutation monitoring assay through its Asuragen brand. ESR1 gene mutations are known to be linked to hormone receptor-positive (HR+) metastatic breast cancer.

The research-use-only assay, which includes a qPCR detection kit and an isolation kit for cell-free DNA and exosomal RNA, will also be featured at the ongoing San Antonio Breast Cancer Symposium. The latest development is expected to bolster the company’s Diagnostics and Spatial Biology segment.

TECH Stock Likely to Gain From the Development

Since the announcement on Dec. 10, Bio-Techne’s shares dipped 0.4%, closing at $76.81 in yesterday’s session.  On a promising note, Bio-Techne’s deep expertise in developing highly sensitive, qPCR-based assays with capabilities in extracting data from exosomes makes it uniquely positioned to provide a high-quality, streamlined and multiplexed ESR1 mutation assay for broad use in clinical research laboratories. Accordingly, we expect the latest development to boost the market sentiment toward TECH stock.

Bio-Techne has a market capitalization of $12.25 billion. The Zacks Consensus Estimate for the company’s fiscal 2025 earnings indicates a 5.1% year-over-year increase on a 5.6% revenue improvement. In the trailing four quarters, it delivered an average earnings surprise of 1.55%. 

Importance of Bio-Techne’s New Assay

While ESR1 gene mutations are extremely rare in cancer patients before treatment, the use of endocrine therapies causes these mutations to emerge in as many as 40% of patients with HR+ metastatic breast cancer. Detecting these mutations quickly is vital for clinicians to spot the early warning signs of treatment resistance and adjust course as appropriate. However, most molecular testing technologies lack the sensitivity needed to detect these mutations, reliably and cost-effectively

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Asuragen's new ESR1 mutation assay, featuring 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 previously attainable with much more expensive, cumbersome, or lower plex technologies.

Industry Prospects Favoring TECH

Per a Fact.MR research report, the global Cell-free DNA mutation diagnostics market was valued at $7.07 billion in 2023 and is expected to grow at a compound annual rate of 24.9% through 2034. Higher incidence rates of cancer, together with higher uptake of personalized medicine and greater awareness about non-invasive diagnostic techniques, ensure a strong growth trajectory in this market.

More Updates From TECH

Last month, Bio-Techne announced a partnership with Leader Life Sciences, granting them distribution rights to Bio-Techne's portfolio across the Gulf Cooperation Council (GCC) countries — Bahrain, Oman, Qatar, Saudi Arabia and the United Arab Emirates. In addition, the company announced a strategic partnership with ALZpath, Inc to accelerate breakthroughs in neurodegenerative disease research and treatment, including Alzheimer's disease.

TECH Stock Price Performance

In the past year, TECH shares have jumped 3.8% against the industry’s fall of 5.6%.

TECH’s Zacks Rank and Key Picks

Bio-Techne currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Penumbra PEN, Haemonetics HAE and Phibro Animal Health PAHC, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Penumbra shares have risen 10.5% in the past year. Estimates for the company’s 2024 earnings per share have jumped 0.7% to $2.81 in the past 30 days. PEN’s earnings beat estimates in three of the trailing four quarters and missed on one occasion, the average surprise being 10.54%. In the last reported quarter, it posted an earnings surprise of 23.19%.

Estimates for Haemonetics’ fiscal 2025 earnings per share have remained constant at $4.59 in the past 30 days. Shares of the company have decreased 3.6% in the past year against the industry’s growth of 17.3%. HAE’s earnings surpassed estimates in three of the trailing four quarters and missed in one, the average surprise being 2.82%. In the last reported quarter, it delivered an earnings surprise of 2.75%.

Estimates for Phibro Animal Health’s fiscal 2025 earnings per share have increased 2.5% to $1.61 in the past 30 days. Shares of the company have surged 113.5% in the past year compared with the industry’s 17.3% rise. PAHC’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 25.47%. In the last reported quarter, it delivered an earnings surprise of 52.17%.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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