Specialty Biomarker Laboratories

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.

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.

Cambridge, Boston, US: The Cambridge Specialty Laboratory combines deep scientific expertise with advanced technology to deliver flexible, high-quality molecular biomarker testing solutions. With more than 12 years of next-generation sequencing (NGS) experience, the team supports sponsors through custom assay development, validation, and testing across a wide range of sample types, helping address biomarker needs that may not be met by standard commercial panels. Supported by a broad suite of NGS platforms, comprehensive quality control processes, and expert scientific review, the laboratory generates reliable, high-confidence data for clinical trials. Investments in automation and workflow optimization further enhance efficiency, enabling faster turnaround times, scalable testing strategies, and cost-effective solutions, while maintaining the highest standards of quality and scientific rigor.

Portland, Oregon. US: The Portland Specialty Laboratory offers advanced automation, flexible extraction technologies, and rigorous quality standards to deliver efficient, cost-effective specialty testing solutions for clinical trials. By leveraging a suite of magnetic bead-based DNA and RNA extraction platforms and automated liquid handling systems, the laboratory supports a wide range of sample types and volumes while reducing manual intervention and improving consistency. These technology investments enhance workflow efficiency, accelerate turnaround times, and provide scalable, study-specific solutions tailored to sponsor needs. Supported by robust sample tracking and data integrity measures, Portland’s flexible operational model enables accelerated timelines and high-quality results without compromising scientific excellence.

We believe that early engagement is key to overall success. Our R&D 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.