Bio-Techne's Ella Platform Achieves CE-IVD Marking Expanding Access to Rapid, Cartridge‑Based Immunoassays for European Clinical Laboratories

Rhea-AI Summary

Bio-Techne (NASDAQ: TECH) announced on Feb 16, 2026 that its Ella benchtop immunoassay platform received CE‑IVD marking and is now available for sale in the European Union. The cartridge-based system delivers biomarker results in under 90 minutes with minimal hands-on time.

The CE‑IVD mark supports Ella's use in clinical trials, in-house test development, and validated clinical applications, while Simple Plex assays remain indicated for research use only.

Positive

• CE‑IVD marking obtained enabling sale in the European Union
• Ella provides biomarker results under 90 minutes with low hands-on time
• Compatibility with 390+ analytes via the Simple Plex portfolio supports broad application
• Validated platform for clinical trials and in-house test development in EU labs

Negative

• Simple Plex assays remain for research use only, limiting immediate clinical assay availability
• Diagnostic developers must develop clinical applications on Ella before routine diagnostic use

Key Figures

Time to result: under 90 minutes Assay menu size: more than 390 analytes

2 metrics

Time to result under 90 minutes Ella cartridge-based immunoassay system result time

Assay menu size more than 390 analytes Simple Plex portfolio across multiple therapeutic areas

Market Reality Check

Price: $59.93 Vol: Volume 3,679,594 is above...

normal vol

$59.93 Last Close

Volume Volume 3,679,594 is above the 20-day average of 2,646,297, indicating elevated interest pre-announcement. normal

Technical Price at 59.93 is trading above the 200-day MA of 56.9, reflecting a constructive longer-term trend.

Peers on Argus

Two biotech peers in the momentum scan (MRNA, CORT) were moving up with gains of...

2 Up

Two biotech peers in the momentum scan (MRNA, CORT) were moving up with gains of 3–4%, but there is no evidence that TECH’s move was part of a broader, synchronized sector rotation.

Historical Context

5 past events · Latest: Feb 11 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 11	Leadership change	Neutral	-2.1%	Leadership transition in Diagnostics and Spatial Biology segment announced.
Feb 04	Dividend declaration	Positive	+6.3%	Quarterly cash dividend and fiscal 2025 net sales over $1.2B disclosed.
Feb 04	Earnings release	Positive	+6.3%	Q2 FY2026 results with stronger margins and GAAP income improvement.
Feb 02	Product launch	Positive	+1.8%	Launch of Cultrex Synthetic Hydrogel for 3D stem cell and organoid culture.
Jan 28	Assay launch	Positive	-3.9%	Ultra-sensitive Simple Plex assays on Ella platform for neurological biomarkers.

Pattern Detected

TECH has generally reacted positively to financial and product innovation news, while leadership changes and certain platform launches have seen weaker or negative follow-through.

Recent Company History

Over the last few weeks, Bio-Techne reported flat but profitable results with Q2 FY2026 revenue of $295.9M and adjusted operating margin of 31.1%, alongside a quarterly dividend of $0.08 per share and prior Q1 revenue of $286.6M. Product launches, including Simple Plex ultra-sensitive assays on Ella and Cultrex Synthetic Hydrogel, highlight a focus on innovation. Today’s CE‑IVD certification for Ella extends that trajectory into regulated clinical settings, building directly on recent Ella platform enhancements.

Market Pulse Summary

This announcement extends Bio‑Techne’s Ella platform into regulated clinical use via CE‑IVD marking,...

Analysis

This announcement extends Bio‑Techne’s Ella platform into regulated clinical use via CE‑IVD marking, adding to earlier ultra‑sensitive assay launches and recent earnings showing revenue of $295.9M with margin expansion. The news highlights a push toward precision diagnostics and standardized biomarker workflows in Europe. Investors may track subsequent disclosures on clinical adoption, assay menu expansion beyond the current 390 analytes, and how this complements the company’s broader diagnostics and protein sciences strategy.

Key Terms

immunoassay, biomarker, ce-ivd marking, in vitro diagnostic regulation, +2 more

6 terms

immunoassay medical

"Ella is a compact, cartridge-based immunoassay system that delivers accurate biomarker"

An immunoassay is a laboratory test that uses molecules from the immune system (like antibodies) to find and measure specific substances — such as proteins, hormones, drugs or germs — in blood, saliva or other samples. Think of it like a lock-and-key or Velcro system that only sticks to the target item; accuracy, speed and cost of these tests matter to investors because they drive product demand, regulatory approval, reimbursement and a company’s revenue potential in diagnostics and biopharma markets.

biomarker medical

"system that delivers accurate biomarker results in under 90 minutes with minimal"

A biomarker is a measurable indicator found in the body, such as in blood or tissues, that provides information about health, disease, or how the body responds to treatment. For investors, biomarkers can signal the potential success or risk of medical products or therapies, influencing the value of related companies and industry trends. They act like signals or clues that help assess the progress of medical advancements and their market impact.

ce-ivd marking regulatory

"Ella benchtop instrument is now CE-IVD marked and available for sale in the EU"

CE‑IVD marking indicates that an in vitro diagnostic device (tests, reagents, or equipment used to examine samples outside the body) meets European safety and performance rules and is authorized for sale across the European Economic Area. For investors, the mark reduces regulatory and market-entry risk by showing the product passed a recognized conformity process—like a safety sticker that opens many doors—potentially speeding revenue and lowering compliance costs.

in vitro diagnostic regulation regulatory

"complies with the European Union's In Vitro Diagnostic Regulation (IVDR, Regulation"

A set of government rules and oversight that determine how laboratory tests run on samples outside the body are evaluated, approved, labeled and monitored for safety and accuracy. Like building codes for diagnostic tests, these regulations shape how quickly a test can reach the market, what evidence companies must produce, and what costs and legal risks they face—factors that directly affect a medical-device or biotech company’s sales potential and investment risk.

ivdr regulatory

"complies with the European Union's In Vitro Diagnostic Regulation (IVDR, Regulation"

A medical-device regulation that sets safety, performance and market-entry rules for in vitro diagnostic tests — the lab tests and kits used to analyze blood, tissue or other samples outside the body. It matters to investors because it shapes which products can be sold, how long approvals take, and how much companies must spend to comply; like a new building code, tighter rules can raise costs and delay launches but also raise barriers for competitors.

clinical trials medical

"use in clinical trials and in-house test development"

Clinical trials are carefully controlled studies that test whether a new drug, device or treatment is safe and effective in people, moving through successive stages that increase the number of participants and the rigor of testing. Investors care because trial outcomes determine whether a product can be approved and sold, shaping a company’s future revenue, valuation and risk profile—think of it as proof-of-concept testing that decides if a prototype becomes a market-ready product.

AI-generated analysis. Not financial advice.

• Ella benchtop instrument is now CE-IVD marked and available for sale in the EU
• Enables diagnostic assay developers to leverage a simplified platform that delivers speed and reproducible results with minimal hands-on time
• Provides confidence for use in clinical trials and in-house test development   

MINNEAPOLIS , Feb. 16, 2026 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH), a global provider of life science tools, reagents, and diagnostic products, today announced that the Ella benchtop immunoassay platform has received CE-IVD marking¹ and is now available for sale in the European Union. This achievement brings Ella's hallmark ease of use, speed and reproducibility to clinical settings, helping laboratories streamline workflows and support timely decision-making.

Ella is a compact, cartridge-based immunoassay system that delivers accurate biomarker results in under 90 minutes with minimal hands-on time. By simplifying the manual steps of traditional immunoassays, Ella reduces operator variability and provides high-quality, reproducible data suitable for both translational research and clinical applications.

The platform is compatible with Simple Plex™ assays, which remain for research use only, and are powered by R&D Systems antibodies and proteins. With more than 390 analytes across neuroscience, immunology, oncology, and cell and gene therapy, the Simple Plex portfolio enables researchers to maintain consistency and data quality while working efficiently across a wide range of applications.

"Ella's CE-IVD certification marks a significant step forward in advancing precision diagnostics," said Will Geist, President of Bio-Techne's Protein Sciences Segment. "It reflects our commitment to providing innovative tools that enhance clinical decision-making and improve patient outcomes."

With CE-IVD marking now in place, hospitals, clinical laboratories, or other European organizations may use Ella as a validated platform for in-house test development, clinical trials, or other translational activities. Diagnostic assay developers may also develop clinical applications on the Ella CE-IVD validated platform. The certification enhances confidence in Ella's performance and supports Bio-Techne's long-term goal to advance precision medicine by providing dependable, standardized solutions for biomarker detection.

Learn more about the Ella CE-IVD mark and the Ella platform by visiting bio-techne.com/Ella.

^{1 CE-IVD marking signifies that a product complies with the European Union's In Vitro Diagnostic Regulation (IVDR, Regulation (EU)2017/746), confirming its safety, performance, and reliability for clinical use.}

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 over $1.2 billion in net sales in fiscal 2025 and has approximately 3,100 employees worldwide. For more information, visit https://www.bio-techne.com or follow the Company on social media at LinkedIn, X and YouTube.

 

Media Contacts:
Corporate Communications
media.relations@bio-techne.com

David Clair, Vice President, Investor Relations
IR@bio-techne.com

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SOURCE Bio-Techne Corporation

FAQ

What does Bio-Techne's (TECH) Feb 16, 2026 CE‑IVD mark for Ella mean for EU clinical labs?

It permits sale and validated clinical use of Ella in the European Union, enabling clinical test development. According to the company, CE‑IVD confirms compliance with IVDR safety and performance requirements, allowing hospitals and labs to use Ella for clinical trials and in-house assay validation.

How fast does the Ella platform deliver results and what does that mean for TECH customers?

Ella delivers biomarker results in under 90 minutes with minimal hands-on time. According to the company, the cartridge-based workflow reduces operator variability and speeds translational research and clinical decision-making in laboratory settings.

Are Simple Plex assays on Ella cleared for clinical use after TECH's CE‑IVD approval?

No, Simple Plex assays remain for research use only and are not clinically cleared. According to the company, Simple Plex continues as RUO products while the Ella platform holds CE‑IVD marking for developers to build clinical applications on the validated system.

Can diagnostic assay developers build clinical tests on the TECH Ella CE‑IVD platform now?

Yes, developers may create clinical applications on the Ella CE‑IVD validated platform for use in the EU. According to the company, the certification enhances confidence in performance and supports assay development for clinical trials and in-house testing.

Will Bio‑Techne (TECH) sell the Ella platform outside the EU after the Feb 16, 2026 CE‑IVD marking?

The announcement confirms Ella is available for sale in the European Union following CE‑IVD marking. According to the company, CE‑IVD permits EU clinical availability; no details were provided about sales or regulatory status outside the EU.