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.
