Discovering Biomarkers of Human Disease and Development Using 2026

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Biomarker discovery starts with defining a target normal biological process, pathogenic process or pharmacological response that the biomarker could highlight. As part of this process multiple candidates will be identified. Each candidate needs to be validated before it can progress into clinical studies.
Biomarker discovery and development is a lengthy process requiring hypothesis generation, sample collection, data collection, data analysis, assay development, assay validation and finally regulatory approval before it can be used clinically [6].
Biomarker discovery relies on the collection of large specimen collections that have been molecularly profiled. Specimen libraries must also be associated with the disease characteristics of interest such as disease subtype, prognosis, or drug response versus nonresponse.
A diagnostic biomarker detects or confirms the presence of a disease or condition of interest, or identifies an individual with a subtype of the disease. As we move into the era of precision medicine, this type of biomarker will evolve considerably.
Biomarker qualification, as mandated by the 21st Century Cures Act, follows a three-stage submission process to develop a biomarker for regulatory purposes. This process includes the submission of a LOI, a qualification plan, and a comprehensive full qualification package.

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To develop a new biomarker, researchers must first identify and validate the target, and then determine the test characteristics of the biomarker. Once it has undergone initial development and testing, a new biomarker is then tested in the clinical setting before being implemented into practice.

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