BOND Research to BOND Clinical Translation Guide

Why Develop on the BOND RX and BOND RX^m Research Systems?

Researchers require flexibility to explore biomarkers, investigate novel workflows, and optimize assay performance. Clinical systems, by design, operate within a more controlled environment intended to support diagnostic laboratory workflows. When the research platform and the intended clinical deployment environment differ substantially, teams may face redevelopment, revalidation, workflow redesign, retraining, readiness delays, and increased cost.

The key benefit of developing within the BOND ecosystem is not that transfer is automatic. Instead, the research and clinical pathway can be planned against shared technology foundations, common workflow principles, and a related reagent and protocol environment from the beginning.

Shared Technology Foundations

Common Staining Technology

The Leica Biosystems BOND research platforms and BOND clinical platforms are positioned around common staining technology foundations. This includes comparable workflow principles, fluidics design philosophy, reagent ecosystem, and protocol execution framework. By enabling assay development within the broader BOND ecosystem, researchers can focus on scientific innovation while maintaining awareness of future clinical deployment objectives.

Shared Applications

• Immunohistochemistry (IHC)
• In Situ Hybridization (ISH)
• Chromogenic multiplex assays
• Fluorescent multiplex assays
• Translational biomarker studies
• Companion diagnostic feasibility programs
• Laboratory Developed Test (LDT) development

Common Software Foundation

BOND Research and BOND Clinical software applications are built upon a common software foundation.

The primary differences between research and clinical software environments relate to:

• User permissions
• Protocol editing capabilities
• Available workflow features
• Research-specific functionality
• Clinical workflow controls

Research and Clinical Environment Comparison

Shared Reagent Ecosystem

Many Leica Biosystems reagents are available across both BOND research and clinical environments, including:

• BOND Ready-to-Use antibodies
• BOND Detection Systems
• BOND Epitope Retrieval Solutions
• BOND Wash Solutions
• BOND Ancillary Reagents

Choosing clinically relevant IVD reagent families during development can reduce avoidable changes when transitioning from research to clinical implementation. Unlike RUO reagents, IVD reagents are supported by documented performance characteristics and controlled product information—such as stability, shelf-life and lot-to-lot consistency data—providing greater confidence when planning a future clinical assay.

Designing for Future Clinical Translation

Organizations intending to transfer assays from research into a clinical environment should consider future deployment requirements during assay development.

Early consideration of transfer requirements may reduce downstream redevelopment effort and help avoid unnecessary technical challenges.

Examples include:

Research-to-Clinical Assay Development Pathway

A typical translational development pathway may include:

The exact pathway will depend on:

• Intended use
• Regulatory pathway
• Geographic market
• Assay complexity
• Sponsor quality requirements

Leica Biosystems: Enabling and Supporting Clinical Translation

Leica Biosystems supports clinical translation in two complementary ways.

1. A clinical-ready ecosystem
   The BOND ecosystem provides access to established clinical platforms and a broad portfolio of detection systems, antibodies, retrieval solutions, wash solutions and ancillary reagents. Selecting clinically relevant platform components early may reduce avoidable changes, redevelopment and technical uncertainty when an assay moves toward clinical implementation.
2. A development partner for clinical and companion diagnostic programs
   Beyond supplying platforms and reagents, Leica Biosystems can collaborate with customers throughout the development pathway—from early feasibility and assay optimisation to clinical development, evidence generation, regulatory planning and commercial deployment. Our clinical and companion diagnostic development capabilities enable customers to engage the expertise, infrastructure and support needed at each stage of the journey.

Leica Biosystems can work with customers to identify factors that may influence future transfer strategies and implementation planning.

Factors That May Affect Transferability

BOND research and clinical systems share relevant foundations, but transferability of a specific assay depends on the details of assay design and the sponsor’s intended clinical application.

Factors that may require additional assessment include:

Identifying these factors early can simplify future deployment planning.

Clinical Translation Expertise in Practice

RNAscope Technology Translation

A practical example of research-to-clinical translation within the BOND ecosystem is Leica Biosystems' collaboration with Bio-Techne Spatial (original partnership with Advanced Cell Diagnostics). Research users may perform RNAscope workflows on BOND RX staining system using research reagents, like the RNAscope 2.5 LSx Reagent Kit (Brown, while related RNAscope-based solutions are also available within the BOND clinical ecosystem through BOND RNAscope Detection Reagents – Brown*.

This example demonstrates how technologies initially deployed within research environments can subsequently be adapted for clinical workflow deployment when appropriate development, validation, and regulatory activities are completed.

*BOND RNAscope products intended use and regulatory status depends on the specific product and region.

Clinical Adoption of the BOND Ecosystem

The BOND clinical ecosystem has been used with FDA-cleared and approved products.

Examples include:

BOND Oracle HER2 IHC System

The BOND Oracle HER2 IHC System is FDA PMA approved for use on BOND-MAX clinical instruments and represents one example of a clinically deployed assay within the BOND ecosystem.

BOND MMR Antibody Panel

The BOND MMR Antibody Panel received FDA 510(k) clearance (K213348) for use on BOND-MAX and BOND-III clinical systems.

Companion Diagnostic Collaborations

Leica Biosystems has publicly disclosed collaborations with pharmaceutical and biotechnology organizations for companion diagnostic development and commercialization.

These examples demonstrate adoption of BOND clinical platforms but do not imply regulatory approval or clearance of customer-developed assays.

Important Regulatory Considerations

BOND research staining systems are Research Use Only (RUO) instruments and are not intended for diagnostic procedures. Transfer of an assay from a research platform to a clinical platform does not eliminate sponsor-specific responsibilities relating to:

• Verification
• Validation
• Risk management
• Regulatory submissions
• Intended-use claims
• Quality system compliance

Customers should consult Leica Biosystems regarding specific transfer strategies, implementation planning, and regulatory considerations.

Conclusion

BOND RX and BOND RX^m research systems provide researchers with the flexibility needed to innovate while remaining aligned with the Leica Biosystems clinical staining ecosystem.

Through common technology foundations, shared reagent frameworks, aligned protocol architectures, and established clinical deployment platforms, BOND research systems can serve as an effective starting point for translational research, laboratory-developed tests, and companion diagnostic programs.

By considering future clinical objectives early in assay development and collaborating with Leica Biosystems throughout the process, organizations can reduce technical uncertainty and establish a potential pathway from biomarker discovery through to clinical implementation.

BOND-MAX and BOND-III are For In Vitro Diagnostic Use.
BOND RX^m and BOND RX are For Research Use Only. Not for use in diagnostic procedures.