Biomarker Services

Build a Biomarker Strategy That Advances With Your Program

Biomarkers can help you understand disease biology, confirm mechanism of action, evaluate safety and efficacy, and connect preclinical findings with clinical development. WuXi Biology and Testing provides integrated biomarker services from discovery through preclinical and clinical studies, helping you select relevant biomarkers and generate data suited to each program decision.

Our scientific and regulatory teams support feasibility assessment, assay development, qualification, validation, transfer, and sample analysis. By aligning the biomarker, analytical approach, matrix, and level of validation with the intended use, we help you build a practical strategy that can evolve as your program advances.

Biomarker Strategy Across Development

The value of a biomarker depends on the question it is intended to answer. Early discovery studies may use exploratory biomarkers to characterize pathways, disease progression, therapeutic response, or metabolic and toxicity signals. As a program moves forward, translational biomarkers can support cross-species interpretation, PK/PD relationships, and continuity between preclinical and clinical studies.

We work with you to define the intended use, sample types, performance requirements, and development pathway before selecting or developing an assay. This decision-based approach helps avoid overdevelopment in early research while preparing methods for greater rigor when regulatory or clinical use requires it.

Assay Development and Validation

Biomarker identification and feasibility assessment
Assay development, optimization, and characterization
Fit-for-purpose qualification for exploratory and translational studies
Bioanalytical validation aligned with study and regulatory expectations
Cross-species and matrix bridging from preclinical to clinical development
Method transfer, sample analysis, data reporting, and archival support

Fit-for-Purpose Analytical Approaches

Platform selection should follow the biology and intended use of the biomarker—not the instrument available. Key considerations include analyte type, sample matrix, required sensitivity, dynamic range, sample volume, multiplexing needs, throughput, and development stage.

Our platform-agnostic capabilities include LC-MS/MS; ligand-binding immunoassays such as ELISA, MSD, and Simoa; and molecular methods including qPCR, flow cytometry, and tissue-based or pathology approaches. Single-analyte and multiplex methods can be applied as appropriate to provide scientifically meaningful and decision-ready data.

Small Molecule Biomarkers

Large Molecule Biomarkers

Biomarker Types and Applications

Biomarker programs may include soluble proteins, enzymes, cytokines, metabolites, lipids, cell-based markers, gene-expression markers, signaling markers, and tissue-based endpoints. Samples can include cell cultures, serum, plasma, urine, cerebrospinal fluid, and tissue extracts, depending on the scientific objective and study design.

These biomarkers can support pathway and mechanism studies, PK/PD assessment, disease and therapy-response monitoring, safety evaluation, translational research, and companion diagnostic development. Targeted and multiplex approaches can also help characterize complex biological responses when multiple analytes or cell populations must be evaluated together.

Therapeutic Areas and Modalities

Our biomarker capabilities support programs across oncology, immunology, central nervous system, cardiovascular, metabolic, infectious disease, toxicology, and other research areas. We also support biomarker strategies for small molecules, large molecules, oligonucleotide therapeutics, peptides, antibody-drug conjugates, and other emerging modalities.

Assay design is tailored to the biology, modality, species, matrix, and development stage so that the data remain relevant to the decisions your team needs to make.

Discovery-to-Clinical Continuity

Maintaining continuity requires more than repeating the same assay at each stage. Biomarker methods may need to bridge species, matrices, laboratories, and validation levels as a program advances. Our teams can plan for these transitions early, helping you preserve biological relevance while adapting performance requirements and quality controls to the intended use.

Integrated support can include method transfer, clinical sample analysis, pathology, flow cytometry, molecular testing, sample management, data management, and reporting. This coordinated approach helps reduce avoidable gaps between discovery, preclinical, and clinical development.

Clinical and Laboratory Support

Capabilities can be combined based on the scope and stage of your biomarker program.

Clinical biomarker sample analysis
Histopathology and molecular pathology
Flow cytometry and immune profiling
Molecular biomarker testing
Companion diagnostic development support
Sample management and clinical trial logistics
Project setup, laboratory manuals, and site support
Controlled data management, transfer, reporting, and archives

Existing Methods and Custom Assay Development

Start with an existing qualified or validated biomarker method when it meets your scientific and regulatory needs, or work with us to develop a proprietary assay for your program. Our teams can help you evaluate feasibility, select the appropriate platform, and define a development plan aligned with the intended use.

Explore our Small Molecule Biomarkers and Large Molecule Biomarkers pages for more detailed assay information, or contact us to discuss a custom biomarker strategy.