Biomarker Testing and Analysis: Quantitate Biological/Pathogenic Processes or Pharmacologic Response to Therapy in the Body

Biomarker testing services provide a powerful approach to measuring biological process indicators in normal and pathological conditions or in response to pharmacological intervention. Biomarker analysis in blood or other bodily fluids at either the DNA or protein level has been used by physicians for decades to study human diseases. Physicians readily rely on biomarker services to diagnose and manage clinical conditions such as cardiovascular diseases, cancer, immune responses, and genetic disorders. However, the application of biomarker assay in research has recently exploded out of a desire to gain crucial information about biological reactions upon exposure to novel therapeutic compounds.

Clinical biomarkers in drug discovery and development are crucial at all phases, from drug discovery to first in human trials. Biomarker assay services are used extensively in the earlier stages of the drug discovery process for mechanistic or pharmacodynamic purposes such as determining the mechanism of action, validating drug targets, monitoring therapeutic responses, and guiding compound selections. Thus, early biomarker analysis services measure biological response and helps decide whether potential therapeutic agents should be pursued further or discontinued. Later in the drug development process, biomarker testing is expanded to include clinical biomarker services for patient screening and treatment. These clinical studies include diagnostic, prognostic, and safety biomarker lab services to examine patient populations, patient risks/responses to treatment, and clinical endpoints.

For example, biomarker testing services have been used extensively in drug discovery for cancer resulting from the changes in a cell’s genetic material. Specifically, biomarker analysis services have been used to quantitate these inter and intracellular changes associated with various cancers. One use of biomarker services for cancer lies in evaluating the impact of a drug/compound on cancer cells’ growth. Scientists assess genomic changes, abnormal features, or biochemical effects of the tumor during cancer’s biomarker assay testing to identify the disease’s reproducible signs. Biomarker analysis relies on correlating markers identified previously to categorize samples by disease stage or treatment efficacy.

As a nimble Biomarker CRO, we offer singleplex or multiplex assays on the MSD or Luminex platforms or as commercially available ELISA assays evaluated using a traditional 96 well plate format. All these assays undergo a fit for purpose biomarker validation, including assessing bioanalytical parameters such as accuracy, precision, and sensitivity. Once the biomarker assay is well characterized and robust, it can be relied upon to analyze preclinical or clinical study samples. As a GLP certified CRO specializing in biomarker assay development, we maintain high-quality standards that meet our sponsor and regulatory agency needs. Some of our most popular biomarker assay services include assay development, method validation, and cytokine testing.

Fit for Purpose (FFP) Biomarker Assay Development and Validation

Biomarker assay development and validation are crucial in establishing a robust bioanalytical method to quantify a specific biological response in our chosen biological matrix. Afterward, biomarker analysis plays a significant role in assessing the efficacy and safety of novel or repurposed therapeutic compounds. US FDA and other regulatory agencies require fit for purpose (FFP) biomarker validation and assay characterization depending on expected context of use (COU) to ensure data integrity and reproducibility fundamental to each clinical trial's success.

Biomarker assay development begins by examining the biomarker of interest, selecting a suitable analysis platform, and surveying available or made-to-order materials such as kits, recombinant or natural reference proteins, capture/detection antibody pairs, diluents, buffers, substrates, reagents, control matrices, etc. Next, we perform a pre-validation test run of the biomarker assay with calibration standards and quality controls to analyze a few sponsor samples in duplicate. Once the preliminary biomarker development is complete, our team of expert scientists performs proper validation for each of your biomarker services to demonstrate method reliability for the intended use.

For early drug development, such as compound selection or proof of concept, the extent of biomarker validation depends on sponsor preference. Generally, US FDA recommends full biomarker assay validation if the study results will inform regulatory decision-making, such as ascertaining drug safety or product labeling. Per FDA biomarker method validation guidance, we must evaluate all critical assay parameters to lie within approved acceptance criteria for accuracy, precision, selectivity, sensitivity, dynamic range, etc. Furthermore, biomarker validation may also cover stability, parallelism, specificity, dilution effects, and prozone effect.

We hold extensive expertise in a wide range of biomarker assay development and validation services to meet your needs through all stages of the drug development process. Specifically, our biomarker assay services include custom assays using proprietary or commercially available antibodies, research use only (RUO) kits, and singleplex or multiplex MSD or Luminex assays. Additionally, we perform your preclinical and clinical biomarker testing after necessary assay validation.

Biomarker Assay, Analysis, and Testing Services Offered by NorthEast BioLab

Biomarker Assay and Testing Services Offered by NorthEast BioLab

As a Biomarker CRO, NorthEast BioLab offers end-to-end biomarker analysis during drug discovery, preclinical and clinical studies. Our scientists have extensive experience setting up biomarker assays to quantitate proteins, peptides, and small molecules in various biological matrices such as blood, plasma, serum, urine, cerebrospinal fluid (CSF), organ tissue homogenate, etc. These biomarker studies can be performed using a traditional ELISA assay or one of our advanced biomarker assay platforms (LC-MS/MS, MSD ECL, Luminex Multiplex). We offer these biomarker testing services for analysis of your study samples through custom assay development or commercially available assay kits:

Custom Biomarker Assay Development, Validation, and Analysis

Our custom biomarker development services support analysis using proprietary or commercially available materials, such as anti-ID antibodies or antibody pairs from the sponsor. Depending on study needs, our scientists can set-up your biomarker assays individually (single-plex assay) or combined to simultaneously analyze multiple analytes (multi-plex assay) on MSD ECL or Luminex Multiplex platform. Each project begins by consulting with our biomarker lab experts to determine the analytes(s) of interest, the species/sample matrix, sample quantity, QC requirements, dynamic range, and assay platform. Afterward, a preliminary run consisting of a standard curve and QC samples is performed to assess project feasibility with desired multiplexing or dilution.

Once method development and protocol optimization are complete, we perform biomarker validation services to measure bioanalytical parameters such as accuracy, precision, and recovery. Afterward, NorthEast BioLab issues a hyperlinked biomarker method validation pdf report documenting your eCTD submission-ready assay. Henceforth, your fully validated and robust biomarker assay is reliable for all phases of the drug development, from GLP preclinical studies to clinical biomarker testing.

Similarly, we understand that you may have validated ELISA assays to be transferred on a multiplexing biomarker assay platform. Both the Luminex and MSD platforms benefit from the traditional ELISA assay but offer significant advantages of using smaller sample volumes to analyze multiple analytes simultaneously. Consequently, these platforms lead to increased throughput, reduced costs, and more flexibility. Our team of scientists can also seamlessly transfer your existing ELISA assays to either the Luminex or MSD multiplex platforms. The transferred assay can then be used alone or combined with other biomarkers to create a panel to meet your unique drug development and research needs.

Biomarker Testing Services using Commercial Assays and Kits

NorthEast BioLab provides biomarker testing services with an exhaustive menu of 600+ analytes in the usual biological matrices, given the attractive risk/reward profile of commercial assays. We offer biomarker analysis services using a singleplex or multiplex panel for a wide range of applications such as immunology/inflammation, cardiology, toxicology, and metabolic disorders. Furthermore, our preclinical and clinical biomarker services include cytokine testing in humans, mice, rats, dogs, pigs, non human primates (NHP), and other species.

NorthEast BioLab’s committed to delivering the best possible outcome for your biomarker services on MSD and Luminex platforms, keeping pace with the latest technological advances that allow multiplexing from a single sample with a small volume. Our scientists closely partner with industry-leading kit providers (Meso Scale Discovery, Millipore Sigma, Thermo Fisher Scientific, R&D Systems, Biorad, etc.) to accurately analyze your biomarker study samples. Thus, our vendors’ technical support empowers us to provide reproducible and reliable results using pre-validated biomarker panels or custom assay panels even for your most challenging biomarker services.

We can perform these biomarker lab services according to manufacture specifications or customize protocol to meet your bespoke research and development goals. Before biomarker analysis on your precious study samples, our team conducts a pre-validation run to optimize assay, such as determine minimum required dilution (MRD) and assess quality controls against standard curve to gauge % recovery. Per your regulatory requirement, we happily perform biomarker validation services on these commercial assays to thoroughly analyze bioanalytical parameters such as accuracy, precision, sensitivity, dilution effects, etc.

One of our most popular biomarker services is Cytokine testing, which is a crucial part of many research studies capturing the expression of immune and inflammatory responses. We offer multiple cytokine assay profiling services on both Meso Scale Discovery (MSD) and the Luminex platforms. These biomarker development and validation services are fully customizable and range from small panels containing a few cytokines of interest to larger pre-validated cytokine profile panels. Below, please find some of our standard cytokine testing panels.

Panel Assay Platform Analytes
V-plex Mouse Cytokine 19-plex MSD IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12p70, IL-15, IL-17A/F, IL-27p28/IL-30, IL-33, IP-10, KC/GRO, MCP-1, MIP-1α, MIP-2, TNF-α
V-plex Human Biomarkers 54-plex MSD CRP, Eotaxin, Eotaxin-3, FGF (basic), GM-CSF, ICAM-1, IFN-γ, IL-1α, IL-1β, IL-1RA, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-9, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-17A/F, IL-17B, IL-17C, IL-17D, IL-21, IL-22, IL-23, IL-27, IL-31, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, MIP-3α, PlGF, SAA, TARC, Tie-2, TNF-α, TNF-β, TSLP, VCAM-1, VEGF-A, VEGF-C, VEGF-D, VEGFR-1/Flt-1
Multiplex Mouse Cytokine/Chemokine Panel Luminex xMAP GM-CSF, IFN-γ, IL-1α, IL-1β, IL-2, IL-3,IL-4, IL-5, IL-6, IL-7, IL-9, IL-10, IL-12 (p40), IL-12, (p70), IL-13, IL-15, IL-17, IP-10, KC, LIF, LIX, MCP-1, M-CSF, MIG,MIP-1α, MIP-1β,MIP-2,
Milliplex Human Cytokine/Chemoskine/Growth Factor Panel Luminex xMAP sCD40L, EGF, Eotaxin, FGF-2, Flt-3 ligand, Fractalkine, G-CSF, GM-CSF, GROα, IFNα2, IFNγ, IL-1α, IL-1β, IL-1ra, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p40), IL-12 (p70), IL-13, IL-15, IL-17A, IL-17E/IL-25, IL-17F, IL-18, IL-22, IL-27, IP-10, MCP-1, MCP-3, M-CSF, MDC (CCL22), MIG, MIP-1α, MIP-1β, PDGF-AA, PDGF-AB/BB, RANTES, TGFα, TNFα, TNFβ, VEGF-A

In summary, NorthEast BioLab offers diverse biomarker testing on multiple biomarker assay platforms. We can analyze client samples for one or two analytes individually using traditional ELISA methods or multiplex biomarkers to create panels to maximize study ROI with high integrity data using small sample volumes. All biomarker studies are validated with a fit for purpose approach to fulfill your regulatory needs. Contact us today to discuss your biomarker research needs, whether you are at the discovery phase or getting ready for clinical analysis.

Biomarker Assay List

Biomarker research, discovery, and qualification are pivotal in modern drug development from demonstrating proof-of-concept (POC) to establishing drug safety and efficacy in the clinic…

Appropriate Biomarker Validation and Testing Assay for your Crucial Study Endpoints

NorthEast BioLab has 15+ years track record of various biomarker analysis services for proteins, peptides, and small molecules. Using our industry knowledge, we can accelerate your biomarker assay development, validation, and sample analysis. Our scientists offer dependable biomarker testing services to generate actionable and reproducible data for Sponsors. To that end, we perform fit-for-purpose (FFP) validation for biomarker research to demonstrate assay reliability for the intended use. We ensure high ROI on your biomarker study by fine-tuning commercially available research use only (RUO) kits, pre-validated singleplex assays, or multiplex biomarker panel as per your requirements. Contact us today for a comprehensive analyte menu grouped by species, abundance in tested matrices, multiplex compatibility, LOD/LLOQ/ULOQ range, and regular therapeutic use.

Our team understands that Biomarker assay testing is a crucial aspect of drug discovery and clinical research. It allows biomarker experts to evaluate the impact therapeutic regimens have on various pathological conditions. Biomarker analysis services early in the development phase can identify potential targets and drug candidates and monitor therapeutic responses. Later in the process, clinical biomarker testing is available to address safety and efficacy concerns. We leverage our expertise in GLP biomarker assay testing and complete extensive pre-validation analysis. Specifically, we carefully review the available literature on the biomarkers and assay materials to meet your unique needs. Afterward, we develop a biomarker study plan to partner with the sponsor flexibly, turn around initial data within weeks, iterate biomarker assay, and provide control over sample analysis.

Furthermore, we accept biological samples from sponsors for biomarker discovery services as well. Our veteran scientists perform cytokine or chemokine analyses using LC-MS/MS, ELISA, MSD, Luminex Multiplex, qPCR, and Western Blot biomarker assay platforms. Each biomarker solution has guard rails around capabilities, e.g., which and how many analytes could be multiplexed? Our team does the groundwork to recommend the best biomarker assay platform based on your analytes of interest. Generally, sample analysis effort depends on several factors, such as # of samples, fit for purpose validation (exploratory, fully validated), etc. Sample preparation is an integral part of biomarker assay testing as it dictates the robustness, sensitivity, and selectivity of the test. We ensure full sample chain of custody for biomarker study as contamination and degradation of biological matrices can significantly impact data quality. Our lab analysts follow the best sample handling practices to minimize the effect of these factors. Thus, we work towards enhancing your sample stability throughout the drug discovery and development from collection to storage. As biomarker experts, we can provide consulting and biomarker testing services at all drug development stages.

Above all, we encourage intensive collaboration between our sponsors and scientists for complete transparency throughout your biomarker study with us. NorthEast BioLab offers quick turnaround times, scalability, and flexibility, given our extensive experience with biomarker assay development and validation and a thorough understanding of the science behind it. Thus, our objective of clinical biomarkers in drug discovery and development is to measure a biological response accurately and help you make a scientific decision of whether potential therapeutic agents should be pursued further or discontinued. We enable our sponsors to expedite drug approval through efficient assay development, validation, and optimization while maintaining 100% regulatory compliance.

Related FAQs

Answers to additional Biomarker Testing and Assay Validation Services questions popular among our potential clients.

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