Biomarker Discovery and Validation



Biomarker Discovery and Validation


Biomarker Discovery
Biomarkers provide vital information regarding safety and efficacy during drug discovery and development. They are loosely defined as diagnostic, prognostic, or predictive and can be used to select patients for clinical trials or monitor patient response and treatment efficacy. In addition, after regulatory approval, biomarkers can be used to identify patient populations that would benefit from a particular therapy along with continuing to monitor the treatment’s efficacy. Show more

Biomarkers are used in research to design and develop more effective therapeutics, to assist in guiding decisions about which candidates to develop further, as surrogate markers for the selection of patients, and as endpoints for both benefits and risks. There are a wide range of types of biomarkers that can be monitored, such as predictive, prognostic, pharmacodynamic, safety, and efficacy markers. One class of biomarkers that is actively being researched is safety biomarkers. These markers are being developed to help determine which drug candidates are most likely to be safely tolerated in humans.

From Discovery to Validation
Biomarkers range from specific molecules such as a protein, gene sequence, or expressed RNA to physiological parameters such as blood pressure or body temperature. They may be expressed in a specific location or tissue or found in serum, plasma, and other bodily fluids. Because of this diversity, most successful biomarker programs have a broad reach and investigate cellular, proteomic, and genetic sources in order to find the most valuable biomarkers.

Validation of biomarkers requires that their levels change in response to a disease, condition, or other parameter in a consistent and statistically significant manner. Identification and characterization of biomarkers can reduce the number of candidate drugs that fail clinical trials, aid in the discovery of more effective therapeutics, and provide methods for monitoring animals in preclinical research and evaluating the response of human participants in clinical trials.

Genomic Biomarkers
Both gene expression and the presence of specific genetic sequences are used as biomarkers for many diseases including cancer. Treatments can even be tailored to an individual patient based on these genomic biomarkers. Typically, large-scale gene expression studies are conducted to identify genes that are up- or down-regulated in a particular indication or disease. These studies rely on the ability of the researchers to design exploratory and confirmatory panels as well as on powerful software tools to analyze resulting data and identify potential biomarkers.

Proteomic Biomarkers
Interrogating biological samples to identify proteomic profiles gives rise to a plethora of potential biomarkers. Proteins are vital, functional parts of living organisms and as such reflect what is happening in that organism. Monitoring the post-translational state of proteins of interest can yield important biomarkers and indicate tumor progression.

Cellular Biomarkers
The ability to uncover novel and rare cell types through multiparameter analysis allows researchers to characterize cell populations in greater detail and identify subpopulations that serve as markers for disease. Simple and reliable isolation of these cells for downstream assays further supports the cellular biomarker workflow by providing pure populations for genomic and proteomic analysis. Show less


Cell Sorting for Drug DiscoveryFeatured Video
Automated, Affordable Cell Sorting for Drug Discovery & Development with the S3e™ Cell Sorter


Solutions for Biomarker Discovery

Gene Expression

Gene Expression

Select from a range of validated PCR, qPCR, and digital PCR instruments to incorporate into your biomarker research. Explore our large library of disease-specific and pathway-specific predesigned PCR primers, probes, and assay panels that meet MIQE guidelines, or order custom-designed primers and plates.

CFX Real-Time PCR Detection Systems along with predesigned or custom-built or predesigned PrimePCR™ Panels for pathway or disease state targets allow you to measure multiple genes from multiple samples at once sourced from liquid biopsy, tissue, or cell based materials. Coupled with the CFX Automation System II, up to 48 plates can be read unattended. If increased sensitivity is required, such as for the detection and quantification of CTCs and rare cancer mutations, the QX200 Droplet Digital PCR (ddPCR™) System is an ideal choice, as it allows detection of rare, low-abundance genetic biomarkers. Both systems are provided with IQ/OQ workflows and tools that enable 21 CFR Part 11 compliance.

Real-Time PCR Detection Systems
Droplet Digital™ PCR Systems
ddPCR™ Supermixes for Residual DNA Quantification

PCR Instrument Validation Tools and Services


Protein Expression, Quantitation, and Analysis

Protein Expression, Quantitation, and Analysis

Analyze the expression of biomarkers in complex backgrounds with multiplex immunoassays, 1-D and 2-D electrophoresis, and western blotting.

The V3 Western Workflow™ is a validated and streamlined workflow suite that allows faster quantitation of protein expression with more accuracy than other western blotting systems. By incorporating the ChemiDoc™ MP Imaging System, this workflow allows simultaneous analysis of up to three proteins via multiplex fluorescent western blotting. Bio-Plex Multiplex Immunoassay Systems and Assays allow analysis of large numbers of biomarkers in a single experiment. Predesigned panels for a given indication remove the guesswork from your search, while custom assays allow you to design panels for your unique markers as your biomarker program progresses.

Multiplex Cell Signaling Immunoassays
Multiplex Cancer Biomarker Immunoassays
Multiplex Kidney Toxicity Immunoassays
Custom Multiplex Immunoassays
2-D Electrophoresis Systems
V3 Western Workflow
Stain-Free Gel and Western Blot Imaging Systems

Cell Analysis

Cell Analysis

Bio-Rad offers equipment and reagents for cell-based biomarker evaluation and measurement.

Our comprehensive and easy-to-use suite of cell analysis products includes the ZE5™ Cell Analyzer, the S3e™ Cell Sorter, and the ZOE™ Fluorescent Cell Imager, and includes a wide range of flow cytometry and cell imaging reagents. Examine up to 30 parameters simultaneously with the ZE5 Cell Analyzer to distinguish subtly different cell populations, sort rare and single cells with the S3e Cell Sorter, and perform traditional immunocytochemistry and histochemical studies for biomarkers in live or fixed cells right at your bench with the ZOE Cell Imager.

Cell Sorting and Flow Cytometry
Antibodies for Flow Cytometry
Cell Imaging
Cell Counting



Choose from an extensive range of antibodies for biomarker discovery assays, or utilize our custom antibody services and create your own.

Antibody selection and antibody specificity are crucial to the performance of proteomic assays. Our HuCAL® custom antibody technology can generate highly specific custom human antibodies in only 8 weeks for a variety of applications, including flow cytometry, ELISA, and western blotting.

Antibodies by Application
Antibodies for Diagnostic Assay Development
Antibodies for Drug Discovery and Development
Custom Antibody Services

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Number Description Download
6989 Understanding Biomarkers for Better Drug Discovery and Development, Ver A Click to download
6516 Better, Faster, and Less Expensive Gene Expression Analysis Using Multiplex One-Step RT-qPCR: A Case Study of Colorectal Cancer, Rev A Click to download
5590 Detection of Genetic Abnormalities in Cancer Cells Using Bio-Plex Immunoassays, Rev A Click to download
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