Biomarker Validation

Accelerate the transformation of translational discovery into clinical medicine.

A common question for a scientist with a potentially useful biomarker is: "How do I transition my biomarker from a research lab to become a clinically useful test?"

Once an investigator has addressed the technical issues of target discovery, a critically important series of questions centers around "How can I validate my biomarker in healthy and disease control populations?"

Validation of biomarkers requires testing in three different populations:

  1. in a population known to have the targeted disease
  2. in disease controls that are difficult to distinguish from the targeted disease by means other than the candidate biomarker
  3. in a relevant reference range in age-, race- and sex-matched healthy controls

These clinical validation studies require recruitment of patients not only from an academic medical center setting (often a requirement for rare diseases) but also from the community.

We provide the guidance necessary to set up and perform the validation essential to prove the usefulness of a new biomarker.

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