Validation is the process of evaluating the reliability, reproducibility and accuracy of the biomarker across a range of experimental conditions. Qualification process provides an evidentiary link between the biomarker and biological processes/clinical end points.
Following validation and qualification, a biomarker can be used to diagnose the risk, presence and prognosis of a disease in an individual. In evaluating potential drug therapies, a biomarker may be used as a surrogate for a natural endpoint such as survival or irreversible morbidity. If a treatment alters the biomarker, which has a direct connection to improved health, the biomarker serves as a surrogate endpoint for evaluating clinical benefit. Some of the main areas in which molecular biomarkers are used in the drug development process are: early drug development studies, safety studies, proof of concept studies, and molecular profiling.
We offer assay development and validation for prognostic/predictive clinical biomarkers and pathway activation biomarkers:
Necessary cookies are absolutely essential for the website to function properly. This category only includes cookies that ensures basic functionalities and security features of the website. These cookies do not store any personal information.
Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. It is mandatory to procure user consent prior to running these cookies on your website.
Get a consultation today
We offer more possibilities to meet your every need.