BioAgilytix’s scientists have decades of combined experience providing expert biomarker 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 biomarkers, or collaborate with customers on novel biomarker assay development and validation.
Find Answers to Your Biomarker Questions:
What are your specific assay needs? Let’s schedule a conversation to review your questions and requirements with one of our scientists.
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.
Watch Our Biomarker Webinar:
In this webinar, Afshin Safavi, CSO of BioAgilytix, discusses the considerations for evaluation of accuracy, parallelism and reagent lot-to-lot variability in single and multiplex biomarker ligand binding assays.
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 400 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.
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.
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.
Our Biomarker Disease Expertise Includes:
See how our PK expertise complements our immunogenicity services by evaluating absorption, distribution, metabolism and excretion characteristics of a product.
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.