Bioanalytical Services
Biomarker services for clinical development
Crux Biolabs provides biomarker testing and analysis services to support clinical research and drug development. We help sponsors generate fit-for-purpose biomarker data that can inform pharmacodynamics, target engagement, disease biology and treatment response.
From established assays to customised method development, our scientists work with you to define a biomarker approach aligned with your study objectives, sample requirements and intended use.
Biomarker testing and analysis
Biomarkers are measurable biological characteristics that can provide insight into biological processes, disease activity and response to treatment. They may include proteins, cytokines, chemokines, hormones and other soluble analytes measured in biological samples.
Crux Biolabs takes a fit-for-purpose approach to biomarker analysis. We consider the scientific question, analyte characteristics, biological matrix, sample volume, expected concentration range and required data outputs to select or develop an appropriate assay strategy.
Our services support exploratory biomarker research and clinical programs requiring reliable, well-documented sample analysis and data delivery.
Designed around your study
Every biomarker program has different scientific, analytical and operational requirements. We work with you to define an approach that reflects the biomarker’s intended use, the study objectives and the practical realities of the available samples.
| Study consideration | How Crux approaches it |
|---|---|
| Biomarker and scientific question | Define the analyte, biological rationale and data required to support the study objective |
| Context of use | Align method selection and performance expectations with exploratory research, pharmacodynamics, target engagement, safety monitoring or patient-response assessment |
| Sample matrix and volume | Consider the relevant biological matrix, available sample volume, collection conditions and sample stability requirements |
| Sensitivity and reporting range | Select an assay approach appropriate for expected biomarker concentrations and required reporting range |
| Multiplexing requirements | Determine whether individual-analyte measurement or multiplex analysis best supports the study |
| Method lifecycle | Support assay feasibility, transfer or verification, development, qualification or validation, sample analysis and reporting |
Platforms for soluble biomarker analysis
Crux Biolabs uses established ligand binding and LC-MS/MS platforms to support quantitative measurement of soluble and small-molecule biomarkers in clinical-study samples. Platform selection is guided by the analyte, biological matrix, required sensitivity and selectivity, sample availability, expected concentration range, and whether single-analyte or multiplex analysis is required.
Meso Scale Discovery
Meso Scale Discovery (MSD) electrochemiluminescence assays support sensitive singleplex and multiplex measurement of proteins and other soluble biomarkers. MSD is well suited to studies requiring high sensitivity, broad dynamic range or efficient use of limited sample volume. It can be particularly useful when low-abundance biomarkers need to be measured from small-volume clinical samples.
ELISA
ELISA is a flexible, widely used and cost-effective option for individual biomarker measurement, including proteins, hormones, inflammatory mediators and custom targets. It is often well suited where a single analyte is required and an established assay or commercially available kit meets the study requirements. Crux Biolabs can assess commercially available kits, support method verification and develop fit-for-purpose custom ELISA methods where needed.
Luminex
Luminex technology supports multiplex measurement of proteins such as cytokines, chemokines and other immune mediators. It is particularly useful when multiple related analytes need to be measured from the same sample, helping conserve sample volume while providing a broader view of biological activity.
LC-MS/MS
LC-MS/MS is well suited to the quantitative measurement of small-molecule pharmacodynamic biomarkers, metabolites and other applicable analytes in biological matrices. It can be particularly useful when high analytical selectivity is required, including for complex matrices or structurally similar analytes, and where expected concentration ranges need to be well characterised.
Speed up your program with our pre-validated assays
Crux Biolabs offers selected pre-validated biomarker assays that can provide an efficient starting point when the analyte panel, sample matrix and study objectives align with an available method.
| Assay kit | Platform | Sample matrix | Biomarkers measured |
|---|---|---|---|
| V-PLEX Metabolic Panel 1 Human Kit | MSD | Plasma (P800 tubes) | C-peptide, active GIP, active GLP-1, glucagon, insulin, leptin and pancreatic polypeptide (PP) |
| V-PLEX Proinflammatory Panel 1 Human Kit | MSD | Serum | IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13 and TNF-α |
If a pre-validated assay is not suitable for your required matrix, analytes or intended use, we can help define a fit-for-purpose alternative or customised biomarker method.
Biomarkers in clinical research
Biomarker analysis can support a range of clinical-research objectives, from understanding treatment-related biological activity to investigating changes in disease pathways and patient response.
Pharmacodynamic biomarkers
Assess biological response to treatment
Target-engagement biomarkers
Support evidence that a therapy is interacting with its intended pathway or target
Inflammation and immunology
Measure cytokines, chemokines and other immune mediators
Safety-related biomarkers
Monitor biological changes relevant to potential treatment effects
Disease and patient-response biomarkers
Investigate disease activity, progression or response to treatment
Exploratory biomarker panels
Generate broader biological insights during early clinical research
Quality and compliance
Crux Biolabs applies fit-for-purpose assay development, verification, qualification and validation approaches according to the intended use of each biomarker method. Method selection, performance expectations and supporting documentation are considered throughout the assay lifecycle.
Crux Biolabs operates an ISO/IEC 17025-accredited, GCLP-compliant quality management system. Controlled processes, documented procedures, data review and traceability support reliable biomarker data for clinical research.
Where relevant, we consider applicable regulatory expectations and guidance from authorities including the FDA and EMA. Biomarker-method requirements are determined by the context of use and the role of the data within the study.
Scientific support throughout your biomarker program
Our scientists work directly with sponsors from early assay strategy through to sample analysis and data delivery. We provide practical guidance on assay selection, matrix suitability, sample handling, method performance and data interpretation to help keep biomarker testing aligned with the study objectives.
This collaborative approach supports timely technical decisions and clear communication as study needs evolve. Whether using an established assay or developing a custom method, we work to provide a practical and scientifically appropriate path forward.
Integrated support for global studies
Crux Biolabs works with sponsors requiring biomarker testing in Australia and, where appropriate, coordinated support for international programs through our alliance with KCAS Bio.
This collaboration may support aligned bioanalytical planning and service coordination across study locations. The appropriate approach is defined according to the study requirements, assay needs and operational model.
