Biomarker Assay Development to Support New Therapeutics

BioAgilytix conducts biomarker analysis to support preclinical and clinical pharmacodynamic and disease activity research with new therapeutics, including target validation, high-throughput screening (HTS), lead discovery, and validation of clinical endpoints. We specialize in biomarker assay development, validation, and profiling with singleplex and multiplex biomarker panels, using immunoanalytical and enzymatic platforms, or LC/MS/MS, when appropriate.


Immunoassay-based Single and Multiplex Biomarker Assays

We are experienced with biomarker assays that were a) developed in our lab, b) transferred in from the client’s lab and, most often, c) obtained from commercial kit vendors. This latter option can have financial and logistic advantages, but caution is required, since kits can vary greatly in quality, sensitivity, and other key parameters. Our team is skilled at identifying the biomarker assay option(s) with the greatest bioanalytical sensitivity and specificity that can be delivered in a defined timeline in the most economical manner. Described below are details about singleplex and multiplex options for biomarker analyses.

Singleplex Biomarker Kits

Our scientists’ substantial experience with biomarker studies has prepared us to skillfully identify the best kits and kit vendors. We are also experienced at modifying kits to suit current regulatory expectations. For example, a six-point standard curve is specified by current FDA guidance, and kits usually have less than six standards. Early decisions on which kit to purchase can significantly influence both development and kit costs. Often, there is a choice between using a full kit or just the antibody pair (capture & detect). The antibody pair route is much more economical for long-term projects and has the advantage of using our standard systems for plate wash buffer, etc. Other considerations can be resolved on a case-by-case basis.

Multiplex Biomarker Assays

Our primary technology for multiplex biomarkers analysis uses Meso Scale Discovery (MSD) electrochemiluminescence to achieve high sensitivity. MSD V-PLEX multiplex assays are FFP validated, sensitive, and consistent. Their reagents (tagged antibodies, etc.) can be adapted to build customized multiplex assays from their extensive list of biomarkers. We have substantial experience with this technology and can expertly help you design a multiplex biomarker assay to suit your needs. We are equipped for multiplex fluorescence assays, too.

Non-kit Biomarker Assays

For esoteric biomarkers not offered as kits, or kits with unfavorable performance characteristics, BioAgilytix provides assay development services. We use critical reagents (e.g., capture/detection antibodies, recombinant or natural biomarker reference materials) obtained from the client, commercial vendors or, in the case of antibodies, made to order. Each assay undergoes rigorous testing to ensure high precision and accuracy, while also delivering the sensitivity and specificity required to detect biological levels of analytes in over 35 biological matrices, including blood, serum, plasma, CSF, and tears.

Biomarker Assay Characterization

Validation of biomarker assays usually follows the fit-for-purpose (FFP) approach whereby the degree of assay characterization corresponds to the expected context of use for the data. It is widely accepted that FFP activities can be highly variable. At the one extreme, current FDA guidance specifies that full biomarker assay validations are needed for key regulatory filings (e.g., Phase III related). On the other hand, a minimally qualified multiplex biomarker assay can be used in a screening format to identify those biomarkers of greatest value, which can be subsequently evaluated in greater detail. Our immunology services include development of such strategies to suit your needs and resources.

Small Molecule Biomarker Assays

We develop and validate highly selective bioanalytical methods for the quantitation of small molecule biomarkers in serum, plasma, CSF or other relevant matrices, using LC/MS/MS. Biomarker compounds previously analyzed using LC/MS/MS include adenosine, androstenediol, androstenolone, arginine, cAMP, cGMP, cinnamic acid, citrulline, cortisol, creatinine, dopamine, glutamic acid, glycosaminoglycans, methionine, and polysaccharides. Compounds such as thiamine and thiamine diphosphate can be measured using HPLC coupled with fluorescence detection.

Many novel and proprietary biomarker assays have been developed, tested, and validated for analysis in various tissue homogenate, including brain tissue. GLP compliant validations are performed in compliance with all regulatory agencies. We can support customized and compliant biomarker analysis for both preclinical and clinical development.

In many cases, PK/PD modeling and statistical analysis can be performed to describe the relationship between the biomarker concentration-time profile and the dosed therapeutic.

Non-Proprietary Assays

BioAgilytix has developed more than 2,000 proprietary and non-proprietary methods, including over 100 non-proprietary assays.

See Full List of Non-Proprietary Assays

Equipment and Software for Biomarker Assay Development

BioAgilytix is one of the largest bioanalytical LC/MS/MS laboratories on the West Coast of the United States. The instrumentation at our facilities is state-of-the-art and constantly upgrades equipment to remain at the forefront of the industry.

See Our Complete Equipment and Software List

Featured Case Study

Biomarker Analysis by LC/MS/MS

Learn how optimizing enzymatic digestion to create a stable derivative enabled us to develop an LC/MS/MS method to measure concentrations of a key biomarker directly related to the activity of a biologic.

Read Case Study