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:
- in a population known to have the targeted disease
- in disease controls that are difficult to distinguish from the targeted disease by means other than the candidate biomarker
- 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.