Biomarker Assay Development and Validation

Biomarker Assay Development and Validation

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Biomarker Assay Development and Validation


Creative BioMart has extensive experience in developing and validating biomarker assays, providing full support for the discovery and development of biomarkers to aid kinase/phosphatase biology and pharmaceutical research. Our firsthand knowledge and advanced technology enable us to meet customer expectations and help them accelerate drug development.


A biomarker is usually a chemical, physical, or biological indicator that can be measured to assess normal biological processes, the presence or severity of disease state, or pharmacological responses to therapy. Given their importance to medicine, biomarkers have become an integral part of drug development. Biomarkers can also provide insight into the prediction, progression, diagnosis, or prognosis of diseases. Reversible phosphorylation is involved in virtually all aspects of cell life, and therefore, abnormal phosphorylation has been found to be associate with cancer, neurological disorders, and many other diseases. Kinases, phosphatases, and phosphoproteins as key players in phosphorylation have emerged as important molecular targets and biomarkers.

Biomarkers are becoming increasingly important in preclinical and clinical research. Accurate and reproducible methods are essential for successful biomarker discovery and development. Well-developed biomarker assays can provide a valuable dimension to pharmaceutical research. Each biomarker assay must undergo a validation process to ensure that reproducible and accurate data can be obtained and the assay performance can match the intended application.

Different electrophoretic mobilities of unphosphorylated and phosphorylated peptide substrates.

Figure 1. The pharmacological biomarker audit trail. (Paweletz C P, et al., 2011)

What We Offer

Creative BioMart provides comprehensive biomarker services supported by a team of scientists specializing in biomarker assay development and validation. We have developed a wide range of biomarker assays and guarantee to deliver the results in a defined timeline.

Major Molecule Types

Key Technology Platforms

Assay Parameters

  • DNA
  • RNA
  • Proteins
  • Cytokines
  • Enzymes
  • Lipids
  • Small molecules
  • LC-MS/MS
  • Flow cytometry
  • Immunohistochemistry
  • Microarrays
  • Quantum dot
  • Analytes to be measured
  • Sample types
  • Types of assays to be developed
  • Detection mode
  • Availability of detection reagents
  • Data analysis methods
  • Expected Result formats

Applications of Biomarkers

Therapeutical Areas

Validation Parameters

  • Screening/detection
  • Diagnosis
  • Prognosis
  • Prediction
  • Monitoring
  • Risk assessment
  • Oncology
  • Neurology
  • Infectious disease
  • Metabolism disease
  • Cardiology
  • Other areas
  • Precision
  • Accuracy
  • Specificity
  • Selectivity
  • Repeatability
  • Reproducibility

Service Workflow

Service Workflow of Biomarker Assay Development and Validation – Creative BioMart

Creative BioMart has a scientific team with many years of experience in kinase/phosphatase biology research and drug development who will work closely with our customers to develop and validate biomarker assays for their cutting-edge research. If you need any further information, please feel free to contact us at any time. We will get in touch with you as soon as possible.


  • Paweletz C P, et al. Identification of direct target engagement biomarkers for kinase-targeted therapeutics. PLoS One, 2011, 6(10): e26459.
  • Chen G, et al. Biomarker Assay Development, Qualification, and Validation. Statistical Methods in Biomarker and Early Clinical Development. Springer, Cham, 2019: 87-115.
For research use only. Not intended for any clinical use.