This phase of the assay development project focuses first on primarily three important topics:
FREEDOM TO OPERATE
This important piece is often overlooked by the beginner whom, upon finding clinical utility, has not done the homework to see if the technology or antigen or antibody or type of assay is covered by some existing patent. FTO should not be cast aside until later as it is one of the first elements one needs to be sure of before proceeding with the new or novel biomarker assay. Often there are way around some patents, but others are written more broadly that can be difficult or impossible to navigate.
CLINICAL STUDIES (sometimes called Alpha studies)
These are the initial proof of concept studies that attempt to demonstrate that your biomarker has clinical utility. These should be, if possible, mutli-site and have control populations along with intended use populations with enough sample size to ensure validity of results. These studies can often be plagued by poor initial assay design or format that may introduce artifacts into the results.
HEALH ECONOMICS (Insurance Reimbursement)
One important aspect of the biomarker is that it has to be useful in treating patients. Often we can link some aspect of patient health to a biomarker but there is no way to treat it or use that information to improve the clinical outcome of the patient. Good examples of these are Alzheimer and Traumatic Brain Injury markers. Until effective treatments are developed, these will likely be difficult to market to doctors and ultimately insurance companies.