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.
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NorthEast BioLab is by far the most responsive and thorough bioanalysis lab services CRO.
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We trust NorthEast BioLab to design and execute the most streamlined and impactful bioanalytical projects.
We found their integrity as refreshing as readiness to provide creative scientific input and high-quality data.
We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.
NorthEast BioLab tremendously supported us in reproducing our critical lab discoveries for drug metabolism.
NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.
NorthEast BioLab truly goes that extra mile, and we hope to continue enjoying seminal interactions with them.
NorthEast BioLab presents a science-based, hands-on, no-frills approach on the latest bioanalytical platforms.
We are thrilled to complete our bioanalytical studies with their top quality and incredibly responsive team.
We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.
Our projects with NorthEast BioLab include successful method development, validation, stability studies during Clinical Phase I – IV studies.
NorthEast BioLab provides critical insight, and are compliant with regulatory standards and industry best practices. We highly recommend them and look forward to working together again.
Our latest successful study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis.
This study, same as all other bioanalytical studies with NorthEast BioLab, was completed with top quality and reporting standard with incredible responsiveness.
As a small company, our vendors are key members of our project teams. The scientists at NorthEast BioLab are technical experts, who produce high-quality data, on-time, and on-budget.
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 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…
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). Thus, you can leverage our biomarker testing services for 1,000+ analytes on MSD, Luminex, ELISA, LC-MS/MS, qPCR, and Western Blot. Our FDA audited biomarker CRO’s veteran scientists help select the best assay platform and materials for your preclinical and clinical study. We deliver GLP or fit-for-purpose biomarker assay development, validation, and sample analysis for proteins, peptides, and small molecules at industry-leading value and turnaround. Speak to our scientists to get started on your biomarker analysis or cytokine testing. We offer these biomarker testing services for analysis of your study samples through custom assay development or commercially available assay kits:
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.
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, RANTES, TNF-α,VEGF, Eotaxin/CCL11 |
| 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.
NorthEast BioLab has 20+ 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.
Answers to additional Cytokine Analysis, Biomarker Assay questions popular among our potential clients.
Biomarkers are the indicators that measure the normal vs. abnormal biologic and pathogenic processes, as well as pharmacologic responses to therapeutic intervention in the body. Biomarker analysis plays a critical role in medical science to administer patient health and improve drug development. Scientists can measure the response of investigational drugs during preclinical studies and clinical trials with biomarker testing. For example, the life sciences community relies on several well-characterized biomarker assays to demonstrate expected clinical outcomes for various treatments. Thus, Biomarkers are useful in identifying the probability of disease recurrence or progression and predict the favorable or unfavorable response towards any treatment. Examples of biomarkers include:
Clinical biomarker testing assesses the impact of a drug/compound on the human body. Biomarkers are measurable indicators of biological processes in normal and pathological conditions, or in response to pharmacological intervention. Biomarkers are used extensively in the drug discovery process to evaluate the health of a person or the efficacy of a treatment. Biomarkers can be measured in any biological sample, such as tissue, bodily fluids, blood, etc. Biomarker testing occurs at all stages of the drug discovery process and allows scientists to identify robust biomarkers and accurately measure the state of that biomarker in any given individual.
Biomarker research is divided into three types based on the molecules being analyzed – gene, chromosome, and biochemical markers. Gene biomarker testing evaluates mutations within a gene and extra, missing, or incorrect copy number of genes. Chromosome testing analyzes changes at the chromosome level, including deleted, switched, or expanded chromosomal sequences. In biochemical biomarker testing, scientists measure changes in protein quantity or function.
Once biomarker method validation is achieved, the biomarker is utilized in drug development for disease identification and/or treatment options. Biomarker discovery is critical in concept and safety studies for drug development. During the initial phase of drug discovery and development, biomarker research helps in identifying a suitable dose range. This is achieved by evaluating the effect of a specific dose of a drug on the biomarker. Safety biomarkers, on the other hand, are essential to ensure the safe functioning of body organs, such as liver and kidneys, during drug treatment. Throughout drug development and the preclinical/clinical trials, biomarker analysis services helps in maintaining the safety profile and measuring the efficacy of a drug compound.
NorthEast BioLab offers an extensive biomarker menu for qualifying, developing, validating, analyzing, and multiplexing high-quality biomarker testing for large and small molecules. We use LC-MS/MS, ELISA, MSD, Luminex, Western Blot, and qPCR, among other platforms for customized and GLP-compliant biomarker analysis. The level of method validation for biomarker analysis is fit-for-purpose, such as whether we are working with i) exploratory biomarkers for pharmacodynamics information vs. ii) confirmatory biomarkers for pivotal determination of drug safety and efficacy. Given our 15+ years experience in biomarker analysis, we provide novel and established biomarker testing services in numerous biological species and matrices, including most bodily fluids and tissue homogenates.
NorthEast BioLab performs biomarker testing using LC-MS/MS, ELISA, MSD, Luminex, qPCR, and Western Blot, among other technologies. LC-MS/MS offers a highly sensitive and specific biomarker assay with multiplexing potential for a similar class of small molecules. ELISA is a versatile platform for biomarker analysis of large molecules such as proteins, peptides, antibodies, and hormones in the biological samples. Biomarker assay development commonly applies the three major ELISA types: Sandwich ELISA with matched antibody pair for complex and unpurified biological samples, Indirect ELISA for determining total concentration for multiple antibodies in the sample, and competitive ELISA for small antigens or when only one antibody is available.
Furthermore, our scientists offer testing from the entire biomarker menu of Meso Scale Discovery (MSD) and Luminex Multiplex kits to quantify 40+ analytes within the single sample. Advantages of biomarker analysis using these state-of-the-art multiplex platforms include –
Biomarker research can be performed on multiple platforms. Genetic biomarker analysis is carried out using DNA from bodily fluids or tissues. Biomarker labs use DNA sequencing, quantitative polymerase chain reaction (qPCR), microarray-based comparative genomic hybridization (CGH), and gene expression array. Cytogenetic biomarker testing commonly employs karyotyping and fluorescence in situ hybridization. Biochemical biomarker testing generally uses mass spectrometry techniques such as MALDI-TOF-MS and ESI-MS/MS, immunology techniques like MSD, Luminex multiplex, ELISA immunoassay, and Western blot. NorthEast BioLab offers LC-MS/MS, ELISA, MSD, Luminex, qPCR, and Western Blot platform for biomarker development and validation services.
The platforms for biomarker research and analysis are commonly categorized based on their purpose to examine exploratory biomarkers that are potential endpoints to be validated or confirmatory biomarkers that explain significant drug safety and efficacy. Biomarker development provides both diagnostic tools and contextual data interpretation in clinical research. For example, biomarker research platforms could measure therapeutic responses against drug treatment. These platforms can help screen the patient group that would likely have adverse effects from the therapy. Furthermore, biomarker CRO can measure the toxicity associated with drug treatment. Thus, clinical biomarker testing services are pivotal for drug development from establishing proof-of-concept (POC) in vivo to demonstrating drug potential in clinical trials.
Biomarker assays are essential for drug discovery and development as they aid in drug candidate selection and measure drug function. Since biomarker assay services offer the basis for early drug efficacy, it is imperative to select the right biomarker. We offer biomarker lab services for drug discovery, preclinical, and clinical phases.
Drug Discovery
It is possible to meaningfully accelerate drug development with the selection of correct biomarker and identification of optimal biomarker assays. Although there are many steps before a drug candidate reaches the market, accurate and early biomarker method validation enhances decision-making during every phase of drug development. NorthEast BioLab assists in establishing an early efficacy window for a potential drug candidate through robust biomarker development and validation services, thus eliminating the unavoidable, yet predictable, side-effects of a drug product.
Preclinical Study
Biomarker assay validation in preclinical pharmacokinetic and pharmacodynamic models validate the efficacy of the dose for clinical trials. Put differently, our scientists utilize biomarkers in animal studies to understand the duration and effect of exposure to a drug compound in animal studies. Additionally, biomarkers are used in preclinical models to evaluate the optimum dose for clinical trials. Preclinical biomarker assay testing
measures plasma concentration of the compound and corresponding target activity at the site of action.
Clinical Study
Biomarker assay services are critical during clinical trials. Initially, biomarkers are used to specify the inclusion criteria used for human volunteers. During clinical trials, biomarkers can be tracked to measure safety and efficacy, a critical process for drug approval. Biomarkers are also crucial in measuring disease progression during drug treatment. NorthEast BioLab conducts the assay development and validation to identify accurate biomarkers.
Biomarker discovery services ultimately help measure vital drug safety and efficacy data in clinical treatments accurately. There are genomic biomarkers for gene expression and specific gene sequences for disease identification, with treatment based on these biomarkers. Proteomic biomarkers include highly specific and sensitive protein biomarkers that help explain disease pathways, identify high-risk individuals for developing a disease, or explain therapeutic response towards intervention including any side effects. Cellular biomarkers utilize multiparameter analysis for differentiating large and rare sample cell types to provide meaningful information for supporting proteomic and genomic biomarker workflow.
Biomarker discovery is a multistep process that involves biomarker identification, qualification, assay development, validation, and clinical implementation. Biomarker qualification entails identifying biomarkers or biomarker assay, whereas assay development and validation establish fitness for use and implementation in the clinical setting. The outcome of a clinical trial using biomarkers as a surrogate endpoint requires high confidence biomarker study with valuable information on how crucial proteins behave during diseases. Comprehensive biomarker assay validation requires many patients to cover the broader spectrum of outcomes.
In modern medicine, biomarker development services are utilized as a drug approval tool and undergo thorough discovery, validation, and qualification steps. Biomarker development services could span multiple years throughout the drug development and clinical diagnostic use approval. Thus, biomarker development and validation services comprise of a challenging multistep process with only a ~10% estimated success rate of entering in phase I trial. Generally, the biomarker development success rate is affected by pharmacogenetic heterogeneity of patients to treatments and biologic response, the efficacy of administered drugs, and the lack of well-established biomarker assay services.
Biomarker Development has many phases –
Biomarker validation services involve establishing documented evidence of assurance that a specific biomarker will consistently produce an outcome in keeping with its predetermined specifications. Biomarker assay validation follows the “fit-for-purpose” (FFP) principle that includes the many distinct stages from a typical assay validation process. Biomarker assay development and validation are broadly categorized into analytical and clinical validations. Analytical validity signifies how well the biomarker quantitate what it is supposed to measure, ensuring sensitivity, specificity, accuracy, and precision, among other criteria. Clinical validity addresses how well the biomarker fulfills its purpose in predicting a clinically significant outcome, ensuring the diagnostic test or device performs as intended.
Biomarker qualification services entails the development and regulatory acceptance of biomarkers for use in drug development. The traditional route for biomarker acceptance by regulatory authorities is through data submission during a single drug program. In contrast, the Center for Drug Evaluation and Research (CDER) established a Biomarker Qualification Program (BQP) to review biomarkers for a specific context of use (COU) and release relevant information publicly. The qualified biomarker can then be used in multiple drug programs for this COU without re-review, accelerating the drug development paradigm. The US FDA maintains this list of qualified biomarkers to be used by drug developers without re-evaluating their validity. For additional context, biomarker discovery is the process of qualifying the biomarker, demonstrating biomarker assay for specific use in multiple drug programs without reconfirming the suitability, and verifying that the clinical biomarker testing is feasible and reliable. Qualified biomarkers must fulfill their stated context of use (COU).
Biomarker testing plays an essential role in drug development and help evaluate drug efficacy and safety in clinical trials to facilitate regulatory decision making. Examples of clinical biomarker services that we use in everyday life include tracking blood pressure or monitoring the blood glucose level. Biomarker testing services help evaluate molecular pathways leading to diseases, and biomarkers assay development helps in target identification and mechanism of action (MOA). In preclinical development, biomarker assay testing enables dose selection, MOA, and safety assessment. In the clinical phase, biomarker labs support dose selection, stratification, enrichment, as well as safety and efficacy examination. Generally, select biomarker assay development can identify drug efficacy much effectively than traditional clinical endpoints. That said, multiple data points needed to understand these biomarkers.
