We are offering preclinical/clinical biomarker testing Services for more than 1,000 analytes.

We perform biomarker assay development on ELISA, Luminex, MSD, LC-MS/MS, qPCR, Western Blot, etc.

We offer small and large molecules biomarker testing CRO with FDA certification and biomarker assay validation and bioanalysis.

Exactly what do Biomarker Testing Services do?

A potent method of measuring biological process indicators under normal and pathological conditions or in response to pharmacological intervention is offered by biomarker testing services. Physicians have used DNA or protein-based biomarker analysis in blood or other bodily fluids to study human diseases for many years. To diagnose and treat clinical conditions like cancer, immune responses, genetic disorders, and cardiovascular diseases, doctors frequently rely on biomarker services. However, the use of biomarker assays in research has proliferated recently due to a need for vital data regarding biological responses to novel therapeutic compounds.

Clinical biomarkers are essential at every stage of the drug development process, from drug discovery to the first human trials. In the early stages of the drug discovery process, biomarker assay services are widely used for mechanistic or pharmacodynamic purposes such as figuring out the mechanism of action, validating drug targets, tracking therapeutic responses, and assisting with compound selection. Early biomarker analysis services thus assess biological response and assist in determining whether to continue or stop using potential therapeutic agents. Clinical biomarker services for patient screening and treatment are added to biomarker testing later on in the drug development process. These clinical studies look at patient populations, patient risks and treatment responses, and clinical endpoints using diagnostic, prognostic, and safety biomarker lab services.

For instance, the development of drugs to treat cancer caused by genetic changes in a cell has made extensive use of biomarker testing services. To quantify these intracellular and intercellular alterations linked to various cancers, biomarker analysis services have been employed. One application of biomarker services for cancer is to assess how a drug or compound affects the development of cancer cells. When testing cancer biomarker assays, researchers look at genomic alterations, abnormal tumor features, or biochemical effects to find the disease’s repeatable symptoms. When classifying samples by disease stage or treatment effectiveness using biomarker analysis, previously identified markers are correlated.

We provide singleplex or multiplex assays on the MSD or Luminex platforms, as well as commercially available ELISA assays that are assessed using a conventional 96 well plate format. We are a quick-thinking Biomarker CRO. All of these assays go through a fit for purpose biomarker validation process that also evaluates factors related to bioanalytical rigor, precision, and sensitivity. The biomarker assay can be trusted to analyze preclinical or clinical study samples once it has been thoroughly characterized and tested. As a CRO with GLP certification that specializes in developing biomarker assays, we uphold high standards that satisfy the demands of our sponsors and regulatory bodies. Assay development, method validation, and cytokine testing are some of our most well-liked biomarker assay services.

How to Develop and Validate Biomarker Assays?

In order to establish a reliable bioanalytical method to quantify a particular biological response in our selected biological matrix, the development and validation of biomarker assays are essential. After that, biomarker analysis is crucial in determining the efficacy and safety of newly developed or reformulated therapeutic compounds. To ensure the data integrity and reproducibility essential to the success of each clinical trial, the US FDA and other regulatory agencies require fit for purpose (FFP) biomarker validation and assay characterization depending on expected context of use (COU).

The process of developing a biomarker assay begins with an analysis of the target biomarker, the choice of an appropriate analysis platform, and a survey of readily available or specially made materials, such as kits, recombinant or natural reference proteins, capture/detection antibody pairs, diluents, buffers, substrates, reagents, control matrices, etc. Then, using calibration standards and quality controls, we run the biomarker assay for a pre-validation test run on a few sponsor samples in duplicate. Our team of knowledgeable scientists performs proper validation for each of your biomarker services after the preliminary biomarker development is finished to show method reliability for the intended use.

The degree of biomarker validation for early stages of drug development, such as compound selection or proof of concept, depends on sponsor preferences. If study findings will influence regulatory decision-making, such as determining drug safety or product labeling, the US FDA generally advises full biomarker assay validation. We must assess every important assay parameter to ensure that it satisfies approved acceptance criteria for accuracy, precision, selectivity, sensitivity, dynamic range, etc., in accordance with FDA biomarker method validation guidance. Furthermore, stability, parallelism, specificity, dilution effects, and prozone effect may also be included in biomarker validation.

To meet your needs throughout all phases of the drug development process, we possess in-depth expertise in a broad range of biomarker assay development and validation services. Specifically, our biomarker assay services include singleplex or multiplex MSD or Luminex assays, research use only (RUO) kits, custom assays using exclusive or commercially available antibodies. After the required assay validation, we also carry out your preclinical and clinical biomarker testing.

List of Biomarker Assays

Modern drug development relies heavily on biomarker research, discovery, and qualification to prove proof-of-concept (POC) and establish safety and efficacy in the clinic.

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. Our scientists meticulously follow and optimize your biomarker assay protocols from sample preparation to testing and reporting for high quality and reproducible biomarker analysis. NorthEast BioLab has significant expertise in single and multiplex analyte quantitation using LC-MS/MS, ELISA, MSD, Luminex, and qPCR. Below, please see a representative list of biomarkers available to be examined by us for your drug R&D in a variety of therapeutic areas, including aging, cancer, cardiovascular, immuno-oncology, immunology, inflammation, metabolism/obesity, neurobiology, etc.

What Services Do You Provide for Biomarker Analysis?

NorthEast BioLab provides end-to-end biomarker analysis for drug discovery, preclinical, and clinical studies as a biomarker CRO. In order to quantify proteins, peptides, and small molecules in a variety of biological matrices, including blood, plasma, serum, urine, cerebrospinal fluid (CSF), organ tissue homogenate, etc., our scientists have extensive experience setting up biomarker assays. Traditional ELISA assays or one of our cutting-edge biomarker assay platforms (LC-MS/MS, MSD ECL, Luminex Multiplex) can be used to conduct these biomarker studies. For more than 1,000 analytes on MSD, Luminex, ELISA, LC-MS/MS, qPCR, and Western Blot, you can thus take advantage of our biomarker testing services. Experienced scientists from our FDA-audited biomarker CRO assist you in choosing the best assay platform and materials for your preclinical and clinical study. We provide the development, validation, and sample analysis of GLP or fit-for-purpose biomarker assays for proteins, peptides, and small molecules at an industry-leading price and turnaround. To begin your biomarker analysis or cytokine testing, contact our scientists. We provide the following biomarker testing services for the evaluation of your study samples using either developed-to-order or readily available assay kits.

Development, Validation, and Analysis of Custom Biomarker Assays

Our specialized services for the development of biomarkers assist in the analysis of materials that are either exclusive or readily available commercially, such as anti-ID antibodies or antibody pairs from the sponsor. Our scientists can set up your biomarker assays on the MSD ECL or Luminex Multiplex platform either individually (single-plex assay) or in combination to analyze multiple analytes at once (multi-plex assay), depending on the needs of your study. Each project starts with a consultation with one of our biomarker lab experts to identify the target analyte(s), target species/sample matrix, target sample quantity, target QC specifications, target dynamic range, and target assay platform. After that, a preliminary run composed of QC samples and a standard curve is conducted to determine whether the project can be multiplexed or diluted as desired.

After method development and protocol optimization, we perform biomarker validation services to gauge the accuracy, precision, and recovery of bioanalytical processes. After that, NorthEast BioLab issues a pdf report with hyperlinks describing your eCTD submission-ready assay. From GLP preclinical studies to clinical biomarker testing, your fully validated and reliable biomarker assay is now trustworthy for all stages of the drug development process.

In a similar vein, we comprehend that you might have approved ELISA assays for transfer to a platform for multiplexing biomarker assays. Both the Luminex and MSD platforms benefit from the conventional ELISA assay, but they also provide important advantages by allowing for the simultaneous analysis of multiple analytes using smaller sample volumes. These platforms consequently result in higher throughput, lower costs, and more flexibility. Additionally, our scientific team can easily move your current ELISA assays to the Luminex or MSD multiplex platforms. In order to create a panel that will suit your particular needs for drug development and research, you can use the transferred assay either by itself or in combination with other biomarkers.

Services for Biomarker Testing with Commercial Assays and Kits

Given the appealing risk/reward profile of commercial assays, we offer biomarker testing services with an extensive menu of 600+ analytes in the typical biological matrices. With a singleplex or multiplex panel, we provide biomarker analysis services for a variety of applications, including immunology/inflammation, cardiology, toxicology, and metabolic disorders. Additionally, we offer cytokine testing in humans, mice, rats, dogs, pigs, non-human primates (NHP), and other species as part of our preclinical and clinical biomarker services.

In order to provide the best results for your biomarker services on MSD and Luminex platforms, NorthEast BioLab is committed to staying on top of the most recent technological developments that enable multiplexing from a single sample with a small volume. For an accurate analysis of your biomarker study samples, our scientists work closely with leading kit suppliers (Meso Scale Discovery, Millipore Sigma, Thermo Fisher Scientific, R&D Systems, Biorad, etc.). Thus, even for your most difficult biomarker services, we are able to deliver reproducible and reliable results using pre-validated biomarker panels or custom assay panels thanks to the technical support of our vendors.

We are able to carry out these biomarker lab services in accordance with manufacturer specifications or create a custom protocol to satisfy your specific needs for research and development. Our team performs a pre-validation run to optimize the assay prior to biomarker analysis on your priceless study samples, such as determining the minimum required dilution (MRD) and evaluating quality controls against standard curve to gauge% recovery. We will gladly perform biomarker validation services on these commercial assays in accordance with your regulatory requirements to carefully examine bioanalytical parameters like accuracy, precision, sensitivity, dilution effects, etc.

Cytokine testing, a vital component of many research studies capturing the expression of immune and inflammatory responses, is one of our most popular biomarker services. On both the Meso Scale Discovery (MSD) and the Luminex platforms, we provide multiple cytokine assay profiling services. These pre-validated cytokine profile panels range in size from small panels with a few selected cytokines to larger pre-validated biomarker development and validation services.

In short we offers a variety of biomarker testing on various platforms for biomarker assays. We can create panels to maximize study ROI with high integrity data using small sample volumes by individually analyzing client samples for one or two analytes using conventional ELISA methods or multiplex biomarkers. To meet your regulatory requirements, all biomarker studies are validated using a fit for purpose methodology. Whether you are in the discovery stage or preparing for clinical analysis, get in touch with us right away to discuss your biomarker research requirements.

Why should you use our services for biomarker analysis and cytokine testing?

We have history of providing small molecule, protein, and peptide biomarker analysis services for over 20 years. We can hasten the development, validation, and sample analysis of your biomarker assays using our knowledge of the sector. For Sponsors, our scientists provide dependable biomarker testing services that result in actionable and repeatable data. For biomarker research, we carry out fit-for-purpose (FFP) validation to show assay reliability for the intended use. By fine-tuning commercially available research use only (RUO) kits, pre-validated singleplex assays, or multiplex biomarker panels in accordance with your requirements, we guarantee high ROI on your biomarker study. For a thorough list of analytes organized by species, frequency in test matrices, compatibility with multiplex, LOD/LLOQ/ULOQ range, and regular therapeutic use, get in touch with us right away.

Our group is aware that testing biomarker assays is an essential component of drug development and clinical research. It enables biomarker specialists to assess the effects of therapeutic regimens on different pathological conditions. Early in the development process, biomarker analysis services can help identify potential targets and drug candidates while also keeping track of therapeutic outcomes. Clinical biomarker testing is available later in the process to address safety and effectiveness issues. We use our knowledge of GLP biomarker assay testing to carry out thorough pre-validation analysis. To meet your particular needs, we carefully review the literature that is currently available on the biomarkers and assay supplies. After that, we create a biomarker study plan to collaborate flexibly with the sponsor, deliver preliminary data within weeks, iterate the biomarker assay, and provide sample control.

Additionally, we accept biological samples from sponsors for our services in biomarker discovery. Utilizing LC-MS/MS, ELISA, MSD, Luminex Multiplex, qPCR, and Western Blot biomarker assay platforms, our seasoned scientists analyze cytokines or chemokines. Guardrails surround each biomarker solution’s capabilities, such as which and how many analytes could be multiplexed. Based on your target analytes, our team conducts the necessary research to recommend the best biomarker assay platform. In general, the effort required for sample analysis depends on a number of variables, including the number of samples, the level of validation (exploratory vs. fully validated), etc. The robustness, sensitivity, and selectivity of a biomarker assay are all determined by the sample preparation, making it a crucial component of the test. For biomarker studies, we ensure a complete sample chain of custody because biological matrix contamination and degradation can have a significant impact on data quality. The best sample handling procedures are used by our lab analysts to reduce the impact of these variables. As a result, we strive to increase the stability of your sample at every stage of drug discovery and development, from collection to storage. We can offer consulting and biomarker testing services at all stages of the drug development process because we are biomarker experts.

Above all, we support close communication between our sponsors and scientists to ensure complete transparency throughout your participation in our biomarker study. Given our in-depth knowledge of the science involved in developing and validating biomarker assays, NorthEast BioLab offers quick turnaround times, scalability, and flexibility. Our goal in using clinical biomarkers in drug discovery and development is to precisely measure a biological response so that you can decide scientifically whether to continue using potential therapeutic agents or to stop. Through effective assay development, validation, and optimization while upholding strict regulatory compliance, we help our sponsors speed up the approval of drugs.

What exactly are biomarkers and why are they important?

The body’s normal vs. abnormal biologic and pathogenic processes, as well as pharmacologic responses to therapeutic intervention, are all measured by biomarkers. Medical science relies heavily on biomarker analysis to manage patient health and advance drug development. With the aid of biomarker testing, researchers can gauge how investigational drugs are responding in both preclinical research and clinical trials. To illustrate expected clinical outcomes for various treatments, the life sciences community, for instance, relies on a number of well-characterized biomarker assays. Therefore, biomarkers are helpful in determining the likelihood of disease progression or recurrence as well as in predicting the favorable or unfavorable response to any treatment. Biomarkers include, for instance:

• Susceptibility/Risk Assessing the likelihood of developing diseases using biomarkers
• Disease detection using diagnostic biomarkers
• Monitoring/Staging Determine the status/stage of diseases using biomarkers
• Pharmacodynamic/Response/Predictive Assessing treatment response with biomarkers
• Estimate the recurrence or progression of diseases using prognostic biomarkers
• Safety Biomarkers—which show toxicity in reaction to therapy

What does biomarker analysis and testing entail?

Clinical biomarker testing evaluates a drug’s or compound’s effects on the human body. Biomarkers are quantifiable indicators of biological processes under both healthy and unhealthy conditions, as well as in response to pharmacological treatment. To assess a person’s health or the effectiveness of a treatment, biomarkers are widely used in the drug discovery process. Any biological sample, including tissue, bodily fluids, blood, etc., can be used to measure biomarkers. All phases of the drug discovery process include biomarker testing, which enables researchers to find reliable biomarkers and precisely gauge the level of that biomarker in a particular person.

Gene, chromosome, and biochemical markers are the three categories into which biomarker research is divided. Gene biomarker testing assesses extra, missing, or incorrectly copied genes as well as mutations within a gene. Analyzing chromosomal changes, such as deleted, switched, or expanded chromosomal sequences, is done through chromosome testing. The quantity or functionality of proteins is measured by scientists during biochemical biomarker testing.

The biomarker is used in drug development for disease identification and/or treatment options once biomarker method validation is accomplished. For drug development, the discovery of biomarkers is crucial for concept and safety studies. Biomarker research aids in determining an appropriate dose range during the early stages of drug discovery and development. This is accomplished by assessing the impact of a particular drug dose on the biomarker. On the other hand, safety biomarkers are crucial for ensuring the safe operation of bodily organs during drug treatment, such as the liver and kidneys. The use of biomarker analysis services during drug development and preclinical/clinical trials aids in maintaining the safety profile and assessing the efficacy of a drug compound.

Which biomarker testing services do you provide?

GCC provides a comprehensive menu of biomarkers for selecting, creating, validating, analyzing, and multiplexing high-quality biomarker testing for both large and small molecules. Among other platforms, we use LC-MS/MS, ELISA, MSD, Luminex, Western Blot, and qPCR for tailored and GLP-compliant biomarker analysis. For example, whether we are working with i) exploratory biomarkers for pharmacodynamics information or ii) confirmatory biomarkers for pivotal determination of drug safety and efficacy, the level of method validation for biomarker analysis is fit-for-purpose. We offer novel and established biomarker testing services in a variety of biological species and matrices, including the majority of bodily fluids and tissue homogenates, thanks to our more than 15 years of experience in biomarker analysis.

How are biomarker tests conducted?

GCC uses a variety of technologies, including LC-MS/MS, ELISA, MSD, Luminex, qPCR, and Western Blot, to carry out biomarker testing. For a similar class of small molecules, LC-MS/MS provides a highly sensitive and precise biomarker assay with multiplexing potential. Large molecules found in biological samples, such as proteins, peptides, antibodies, and hormones, can be analyzed for biomarkers using the flexible ELISA platform. The three main ELISA types—Sandwich ELISA with matched antibody pair for complex and unpurified biological samples, Indirect ELISA for calculating the total concentration of multiple antibodies in the sample, and Competitive ELISA for small antigens or when only one antibody is available—are frequently used in the development of biomarker assays.

To quantify 40+ analytes in a single sample, our scientists also offer testing from the full biomarker menu of Meso Scale Discovery (MSD) and Luminex Multiplex kits. The advantages of performing biomarker analysis on these cutting-edge multiplex platforms are as follows:

• Availability of thorough and component-by-component prevalidated kits.
• Highly precise biomarker testing for samples from humans, non-human primates (NHP), rodents (mice, rats), canines, felines, cattle, and horses.
• Given the wide dynamic range, small sample volumes for analytes with normal and elevated levels.
• High tolerance for serum, plasma, tissue homogenates, and complex biological matrix.
• Being able to compare the sample’s expression of cytokines, chemokines, and other biomarkers.

What platforms are used for biomarker analysis and research?

Numerous platforms can be used for biomarker research. DNA from bodily fluids or tissues is used in genetic biomarker analysis. DNA sequencing, qPCR, microarray-based comparative genomic hybridization (CGH), and gene expression array are all used in biomarker labs. Karyotyping and fluorescence in situ hybridization are frequently used in cytogenetic biomarker testing. Mass spectrometry methods like MALDI-TOF-MS and ESI-MS/MS, immunology methods like MSD, Luminex multiplex, ELISA immunoassay, and Western blot are frequently used in the testing of biochemical biomarkers. NorthEast BioLab provides services for the development and validation of biomarkers using the LC-MS/MS, ELISA, MSD, Luminex, qPCR, and Western Blot platforms.

Platforms for biomarker research and analysis are frequently grouped according to whether they are intended to look at confirmatory biomarkers that explain significant drug safety and efficacy or exploratory biomarkers that are potential endpoints to be validated. In clinical research, the development of biomarkers offers diagnostic tools as well as contextual data interpretation. Platforms for biomarker research, for instance, could compare therapeutic outcomes to drug therapy. These tools can assist in identifying the patient population that the therapy is most likely to harm. Biomarker CRO can also gauge the toxicity of a drug’s side effects. The establishment of proof-of-concept (POC) in vivo and the demonstration of drug potential in clinical trials are both steps in the drug development process that depend on clinical biomarker testing services.

Why is a biomarker assay necessary during the development of drugs?

Because they help in the selection of drug candidates and help determine drug function, biomarker assays are crucial for drug discovery and development. The right biomarker must be chosen because they serve as the foundation for early drug efficacy. For the drug discovery, preclinical, and clinical phases, we provide biomarker lab services.

Drug Research

By choosing the right biomarker and finding the best biomarker assays, drug development can be significantly sped up. Even though there are many steps before a drug candidate is commercialized, accurate and prompt biomarker method validation improves decision-making throughout the entire drug development process. Through effective biomarker development and validation services, NorthEast BioLab aids in establishing an early efficacy window for a potential drug candidate, eliminating the avoidable but predictable side effects of a drug product.

Clinical Trial

The effectiveness of the dose for clinical trials is validated by biomarker assays in preclinical pharmacokinetic and pharmacodynamic models. To put it another way, our scientists use biomarkers in animal studies to comprehend the length and impact of exposure to a drug compound. In order to determine the ideal dose for clinical trials, biomarkers are also used in preclinical models. Preclinical biomarker assay testing quantifies the compound’s plasma concentration and associated target activity at the site of action.

Clinical Research

Services for biomarker assays are essential during clinical trials. Biomarkers are initially used to define the inclusion criteria for using human volunteers. Biomarkers can be monitored during clinical trials to assess safety and efficacy, a crucial step in the drug approval process. Biomarkers are essential for monitoring the development of the disease while taking medication. To locate precise biomarkers, NorthEast BioLab develops and validates assays.

In what ways do biomarker discovery services work?

In the end, biomarker discovery services aid in the accurate measurement of critical drug safety and efficacy data in clinical treatments. Genomic biomarkers are available for determining gene expression and specific gene sequences are used to diagnose diseases and guide treatment. Proteomic biomarkers are sensitive and highly specific proteins that can be used to identify people who are at high risk of contracting a disease, explain the therapeutic response to an intervention, and explain any side effects. Multiparameter analysis is used by cellular biomarkers to distinguish between large and uncommon sample cell types, providing useful data that supports proteomic and genomic biomarker workflow.

Biomarker qualification, assay development, validation, and clinical application are all steps in the multi-step process of biomarker discovery. Identification of biomarkers or biomarker assays is required for biomarker qualification, whereas assay development and validation determine the suitability of an assay for use and application in a clinical setting. In order to accurately predict the outcome of a clinical trial where biomarkers are used as a surrogate endpoint, a high level of biomarker research is required. Numerous patients are needed for thorough biomarker assay validation in order to cover a wider range of outcomes.

How do you define biomarker development services?

As a tool for drug approval in contemporary medicine, biomarker development services go through extensive discovery, validation, and qualification processes. During the drug development and clinical diagnostic use approval processes, biomarker development services may take several years. Consequently, the development and validation of biomarkers is a difficult multistep process with only a 10% estimated success rate for enrolling in phase I trials. The pharmacogenetic heterogeneity of patients’ responses to treatments and biologic responses, the effectiveness of medicines given, and a lack of well-established biomarker assay services all have an impact on the success rate of biomarker development.

• Experimental – sample size needs to be sufficient to detect potential biomarkers; available methods include protein arrays, antibody arrays, ELISA, and immuno PCR-ELISA
• Designing validated probes is difficult and expensive during screening and validation; There are ready-to-use immunoassays like ELISA, MSD, Luminex, and quantitative antibody arrays available.
• Clinical Approval: Applications to regulatory agencies for clinical use approval of biomarker candidates are submitted.

How do Biomarker Validation Services work?

Establishing concrete proof that a certain biomarker will consistently produce results in accordance with its predetermined specifications is the goal of biomarker validation services. Validation of biomarker assays is done in accordance with the “fit-for-purpose” (FFP) principle, which incorporates the various stages of a typical assay validation process. Analytical and clinical validations are the two broad classifications used to describe the development and validation of biomarker assays. The biomarker’s analytical validity refers to how well it quantifies the variables it is intended to measure, as well as other factors like sensitivity, specificity, accuracy, and precision. In order to ensure that the diagnostic test or device works as intended, clinical validity examines how well the biomarker achieves its goal of predicting a clinically significant outcome.

What exactly do Biomarker Qualification Services entail?

The development and regulatory approval of biomarkers for use in drug development are included in biomarker qualification services. The traditional method for getting a biomarker approved by regulatory bodies is to submit data during a single drug program. The Center for Drug Evaluation and Research (CDER) on the other hand created the Biomarker Qualification Program (BQP) to evaluate biomarkers for a particular context of use (COU) and make pertinent data available to the public. The drug development paradigm is accelerated by the qualified biomarker’s subsequent use in numerous drug programs for this COU without additional review. The US FDA continuously updates this list of acceptable biomarkers for use by pharmaceutical companies.

How can the process of developing drugs be enhanced by biomarker testing?

The evaluation of drug efficacy and safety in clinical trials using biomarker testing is crucial to the development of new medications and helps regulatory decision-making. Our daily lives may involve using clinical biomarker services to track our blood pressure or check our blood sugar levels. The development of biomarkers assays aids in target identification and mechanism of action (MOA), and biomarker testing services assist in evaluating molecular pathways leading to diseases. Biomarker assay testing during preclinical development enables dose selection, MOA, and safety evaluation. Biomarker labs assist with dose selection, stratification, enrichment, as well as safety and efficacy testing during the clinical phase. Select biomarker assay development, as opposed to conventional clinical endpoints, can typically identify drug efficacy much more effectively. Having said that, numerous data points are required to comprehend these biomarkers.