Biomarker Validation

Biomarker Validation

Biomarker ValidationBiomarkers are characteristics that are objectively measured and evaluated as indicators of normal biological processes, pathogenic processes, or pharmacologic responses to therapeutic interventions. They are increasingly used in medical areas to predict, study and treat disease. Among cancer medicine, biomarkers, which are often proteins, help to drive patient management such as deciding whether to undergo a given or further treatment for patients and evaluating whether a certain medication will cause more harm than good to patients.

Biomarker validation is the process testing the accuracy, consistency and ability of the biomarker in measuring, representing, and/or predicting the interested normal biological processes, pathogenic processes, or pharmacologic responses to therapeutic interventions. We provide biomarker validation services to test the sensitivity, specificity, analytical and clinical validity of candidate biomarkers of our clients. Expert skills in Biomarker Validation would help our clients developing biomarkers with efficiency and quality.

Our Services

We would present a sound and comprehensive measure of the candidate biomarker for our clients. Our Biomarker validation services are focused on the following aspects:

  • Test sensitivity and specificity

A test is specific if it shows a positive outcome only when the biomarker is present and shows a negative outcome when the biomarker is absent. A test is sensitive if it always gives a positive result when the biomarker is present. Ideally, biomarker tests should have 100% sensitivity and 100% specificity. We estimate the sensitivity and specificity of the proposed biomarker by analyzing the frequency of the biomarker in a population and the number of other diseases or conditions that could also associate with the biomarker.

  • Analytical validity

Test specificity and sensitivity are important parts of analytic validity. Analytical validity indicates how well the biomarker tests are supposed to test. Only when a biomarker shows analytical validity is the biomarker useful. We measure the analytical validity of the candidate biomarker by comparing its results with the results from the best test available according to specificity and sensitivity.

  • Clinical validity

Clinical validity is also an important component of biomarker validation. It is the ability of the biomarker test to predict a clinically important result precisely. Again, test sensitivity and specificity are also essential measures of clinical validity.

  • Clinical utility

The benefits of a biomarker must outweigh deficiencies to have clinical utility in clinical use. We compare the pros and cons of a biomarker in the context of clinical use to measure the clinical utility of the candidate biomarker.

We guarantee the confidentiality and sensitivity of our customers' data. We are committed to providing you timely and high-quality deliverables. At the same time, we guarantee cost-effective, complete and concise reports.

If you are unable to find the specific service you are looking for, please feel free to contact us.


1. Chau, C. H., Rixe, O., McLeod, H., & Figg, W. D. (2008) ‘Validation of analytic methods for biomarkers used in drug development’, Clinical Cancer Research, 14(19), 5967-5976.
2. Hayes, D. F. (2015) ‘Biomarker validation and testing’, Molecular oncology, 9(5), 960-966.
3. Rifai, N., Gillette, M. A., & Carr, S. A. (2006) ‘Protein biomarker discovery and validation: the long and uncertain path to clinical utility’, Nature biotechnology, 24(8), 971.
4. Ludwig, J. A., & Weinstein, J. N. (2005) ‘Biomarkers in cancer staging, prognosis and treatment selection’ Nature Reviews Cancer, 5(11), 845.

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