Assay Focus

Biomarker Testing Services

Premier Biomarker Assay Development and Validation Capabilities

BioAgilytix’s scientists have decades of combined experience providing expert biomarker testing services, and have worked with over 500 analytes in singleplex and multiplex formats across a wide range of disease areas. We are able to leverage our comprehensive menu of validated biomarker assays, or collaborate with customers on development and validation of novel biomarker assays.

Find Answers to Your Biomarker Questions:

Tell Us About Your Project

What are your specific assay needs? Let’s schedule a conversation to review your questions and requirements with one of our scientists.

Biomarker Data: Key to Mitigating Ineffective Treatments

More and more companies are relying more on biomarkers to assess the efficacy, safety, and mechanism of action of drugs to make “go” or “no go” decisions regarding their continued development. That means that the data must be of the highest quality possible. This will help ensure objective measurement and evaluation of characteristics that indicate normal biological processes, pathogenic progresses, or pharmacologic responses to a therapeutic intervention.

As biomarkers continue to gain traction in clinical research, it is essential that their validity be continuously evaluated and re-evaluated. Biomarker validity is integrally tied to biomarker performance and therefore, there has been movement towards standardization for a validation path within the industry. Validation includes proof of concept, experimental validation, analytical performances validation and protocol standardization. Applied to clinical research, biomarkers have the potential to accelerate the speed of drug development and mitigate ineffective treatments. That said, they are not to be confused with clinical endpoints.


biomarker webinar

Watch Our Biomarker Webinar:

Considerations for Evaluation of Accuracy, Parallelism, and Reagent Lot-to-Lot Variability in Biomarker Assays

In this webinar, Afshin Safavi, BioAgilytix Founder and Board Member, discusses the considerations for evaluation of accuracy, parallelism and reagent lot-to-lot variability in single and multiplex biomarker ligand binding assays.

Download Webinar Recording

BioAgilytix Biomarker Services: Making Our Mark in the Next Era of Targeted Drug Development

As a laboratory specializing in large molecule bioanalysis, BioAgilytix’s biomarker assay expertise is virtually unrivaled. Together we have experience working with over 500 biomarkers in singleplex and multiplex formats for a wide range of disease states. Our scientific team also has extensive expertise with many matrices, including serum, plasma, and tissue homogenates.

In fact, BioAgilytix has developed a robust biomarker menu which includes over 500 biomarkers spanning a diverse range of disease states. Over 120 of those biomarkers are validated, with 100+ additional biomarker validations in the pipeline.

Whether we leverage biomarkers from this extensive, ever-growing menu to streamline the time and cost needed for biotherapeutics development, or collaborate with customers to develop and validate their novel assays, we are able to help identify a solution that meets the unique needs of the project, no matter the disease state or phase of development.

biomarker services

Optimal Platforms for Biomarker Studies: Diverse Options for Diverse Applications

The platforms used in biomarker analysis vary based on whether we are dealing with exploratory biomarkers, which help our customers understand the pharmacodynamics or mechanism of action of the compound hypothesis generation, or confirmatory biomarkers, which support pivotal determinations of efficacy. BioAgilytix helps our customers make the optimal choice in this “fit for purpose” approach, typically leveraging the platforms below.

elisa platform analytical device


msd-ecl platform analytical device


gyrolab xl platform analytical device

Gyrolab xP

luminex bio-plex platform analytical device

Luminex Bio-Plex

flow cytometry platform analytical device

Flow Cytometry
(FACS Analysis)

proteinsimple platform analytical device


li-cor odyssey platform analytical device

LI-COR Odyssey

lightcycler platform analytical device


platform comparison guide

bioagilytix platform line-up infographic

Discussing the Modern Challenges of Single and Multiplex Biomarker Validation

Biomarker validation can be confusing. Learn more about how BioAgilytix and the industry are progressing to come to some level of consensus as an industry on guidance and best practices in a blog post from Bioagilytix Founder and Board Member, Dr. Afshin Safavi.

Read More

Your Project Will Benefit From Our World-Leading Biomarker Expertise

Because the uses for biomarkers are quite diverse, they require a contract laboratory partner with a breadth and depth of specialty expertise. BioAgilytix has unmatched experience in developing biomarkers that are safe, easy to measure, cost effective, consistent across sample groups, sensitive to severity, and analytically stable – and validating those biomarkers for everything from exploratory to regulated studies.

Our experts understand the complexities that must be addressed in biomarker studies, and will help you determine the optimal analytical equipment platform to yield high-quality data results. We support biomarkers for oncology, metabolic, autoimmune, neurology, and other disease states, and can offer these services under GLP, GMP, and GCP to meet your regulatory requirements.

biomarker platform expertise

Our Biomarker Disease Expertise Includes:

  • Oncology
  • Metabolic
  • Autoimmune
  • Neurology

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Pharmacokinetics (PK)

See how our PK expertise complements our immunogenicity services by evaluating absorption, distribution, metabolism and excretion characteristics of a product.

Explore our PK services

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Cell-Based Assays

Learn how BioAgilytix provides the specialized large molecule insight and proven GLP / GMP knowledge needed to support a full range of cell-based assay (CBA) requirements.

See our CBA expertise