Specialty Laboratories
Supporting precision medicine programs across all phases of drug diagnostic co-development
ICON Specialty Laboratories partners with clients to design, verify and validate assays for exploratory research through translational studies to clinical validation—providing robust, data-driven insights that accelerate decision-making and enhance therapeutic success.
Biomarker services
We deliver biomarker services spanning the full spectrum of drug development—from early exploratory research through translational studies to clinical validation—providing robust, data-driven insights that accelerate decision-making and enhance therapeutic success.
We support biomarker development at every stage:
Exploratory biomarkers: Support for discovery-phase research, including novel target identification, mechanism-of-action studies, and early proof-of-concept.
Translational biomarkers: Bridging preclinical findings to clinical relevance, including pharmacodynamic (PD) markers, disease progression indicators, and patient selection tools.
Clinical biomarkers: Validated assays for regulatory submission, companion diagnostics, and clinical endpoints.
We offer comprehensive biomarker development and testing services— tailored to your therapeutic area, drug development phase, and regulatory goals. Whether you're targeting early phase stratification or late phase endpoints, we adapt to your needs, addressing the major challenges in biomarker development.
Scientific guidance
Scientific Affairs and RnD teams build strong partnerships with clients, ensuring our customised solutions meet the unique needs of each program.
Trial-integrated design
Close collaboration with sponsors to embed biomarkers directly into study protocols, defining endpoints, validation plans, and data interpretation frameworks.
Regulatory support
Regulatory approval driven by alignment with global standards and best practices, supported by expert guidance at every stage to strengthen confidence in decision-making.
Robust design controls
Design controls help reduce errors, control risks, and provide traceability from the initial concept through testing and final use.
Biomarkers services offering
- Genomics Robust technical proficiency in genomics for retrospective and prospective biomaker analysis.
- Immunohistochemistry (IHC) Custom IHC assay development and validation.
- Multiplex immunofluorescence From slide to strategy: Accelerate decisions with multiplexed insight.
- Flow cytometry Customised flow cytometry solutions. Engage assay experts with extensive experience and expertise.
- Biomarker test menu Enabling faster, data-driven decisions within your clinical trials.
Genomics
Robust technical proficiency in genomics for retrospective and prospective biomaker analysis.
Immunohistochemistry (IHC)
Custom IHC assay development and validation.
Multiplex immunofluorescence
From slide to strategy: Accelerate decisions with multiplexed insight.
Flow cytometry
Customised flow cytometry solutions. Engage assay experts with extensive experience and expertise.
Biomarker test menu
Enabling faster, data-driven decisions within your clinical trials.
The importance of early engagement
We believe that early engagement is key to overall success. Our RnD teams work collaboratively with sponsors to:
- Understand the biomarker needs and requirements
- Share scientific knowledge to design robust assays
- Increase efficacy in custom testing solutions
- Anticipate unique testing requirements in pipeline
Our approach emphasises precision, regulatory readiness, and customised solutions that meet the unique needs of each program.
Beyond the lab: Biomarkers powering tomorrow’s therapies
Biomarkers aren’t just supporting drug development, they’re driving it. This expert-led report produced in conjunction with Drug Target Review explores how biomarker science is advancing trial design, accelerating clinical decisions and driving the future of precision medicine.
