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

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.

As an example, biomarker testing has been used extensively in drug discovery and treatment of cancer. Cancers are typically the result of changes in the genetic material of a cell. Biomarkers have been used to identify these changes associated with various cancers. One use of cancer biomarkers is in evaluating the impact of a drug/compound on the growth of cancer cells. During biomarker discovery for cancer, changes in the genome, abnormal features, or biochemical effects of the tumor are assessed to identify reproducible signs of the disease. Biomarker analysis relies on the measurement of previously identified biomarkers to categorize samples by stage of disease or efficacy of treatment.

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 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 helps in maintaining the safety profile and measuring the efficacy of a drug compound.

Biomarker Assay: From Drug Discovery and Preclinical to Clinical Phases

Biomarker assays are essential for drug discovery and development as they aid in drug candidate selection and measure drug function. Since biomarker assays offer the basis for early drug efficacy, it is imperative to select the right biomarker. Northeast BioLab offers biomarker assay development 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 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, 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 assays test plasma concentration of the compound and corresponding target activity at the site of action.

Clinical Study

Biomarker assays 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 Assay and Testing Services Offered by NorthEast BioLab

Biomarker Assay and Testing Services Offered by NorthEast BioLab

NorthEast BioLab has performed various method development and validation protocols for multiple biomarkers, such as small molecules, peptides, and proteins. Using our industry knowledge, we can assist in method development, validation, and sample analysis of biomarkers as explained below:

Biomarker Method Development and Validation

NorthEast BioLab performs thorough biomarker analysis to develop specific, sensitive, and robust assay. Our objective is to achieve distinct positive and negative outputs to obtain accurate and reproducible results for Sponsors. Our team of expert scientists performs fit-for-purpose validation for biomarker analysis to demonstrate assay reliability for the intended use. For example, we characterize precision, accuracy, recovery, cross-reactivity, and dilution linearity in your biomarker testing as needed. Furthermore, we fine-tune commercially available research use only (RUO) kits, pre-validated individual assays, or multiplex panel as per your requirements. Contact us for a comprehensive menu of biomarker analytes grouped by species, abundance in tested matrices, multiplex compatibility, LOD/LLOQ/ULOQ range, and regular therapeutic use.

Biomarker Sample Analysis

NorthEast BioLab accepts biological samples from sponsors for analysis. Our veteran scientists perform biomarkers, cytokines, or chemokines analyses using LC-MS/MS, ELISA, MSD, Luminex Multiplex, qPCR, and Western Blot. Each platform has guard rails around which and how many analytes could be multiplexed. Our team does the groundwork to recommend the best solution based on your analytes of interest. Generally, sample analysis effort depends on the platform and other factors, such as # of samples, fit for purpose validation (exploratory, fully validated), etc.

Sample preparation is an integral part of biomarker testing as it dictates the robustness, sensitivity, and selectivity of the test. We ensure sample quality for useful biomarker analysis as contamination and degradation of biological matrices can significantly impact biomarker quality. Our lab analysts follow best practices to minimize the effect of these factors on a sample. Our team works towards enhancing sample stability throughout the drug discovery and development from collection to storage.

The Basics of Bioanalysis

The Basics of Bioanalysis

Bioanalysis is an essential tool in drug discovery and development for determining the concentration of drugs and their metabolites as well as various pharmacodynamics biomarkers in biological fluids. In these analyses, scientists use developed an….

Appropriate Biomarker Validation and Testing Assay for your Crucial Study Endpoints

Biomarker assays are a crucial aspect of drug discovery and clinical research as it allows scientists to evaluate the impact of a therapeutic regimen on individual health conditions. Biomarker validation further supports the various stages of drug discovery and development for identifying and bringing reliable therapeutic drug products to the market. NorthEast BioLab helps clients perform biomarker analysis in the early stages of drug development to determine the optimal dose and potential side-effects. Knowledge of the correct dosage and probable side-effects assist our scientists in performing definitive clinical assessments.

Our goal is to assist clients in obtaining regulatory approval of a drug candidate. Hence, our team uses a collaborative approach to maintain full transparency with them. Our process helps us make suitable changes to procedures as dictated by mid-study indicators and the impact observed through biomarker assays. Our teams’ ability to stay nimble leads to a reduction in unnecessary overhead and resource consumption. Ultimately, our efficiency, operational excellence, and resource-effective procedures for biomarker assay development under a regulatory environment always allow us to provide high-quality service to all our clients.

Related FAQs

Answers to additional Biomarker Testing questions popular among our potential clients.

What are Biomarkers, and why are they useful?

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