Step 6 — Validation of both the assay and the clinical utility
- Is the assay adequately reproducible? The FDA has developed guidance documents for the kind of assay variability studies needed to document a product. The web site at: http://www.fda.gov/cdrh/devadvice/ provides the information required by FDA for different types of submissions.
- Do the results of the assay provide usable and important clinical information? Is the information reliable enough to support the intended patient management decision?
Thought should be given to how markers can be efficiently tested for more than one clinical use, e.g., prediction and prognosis, taking into account the example of the HER2 history.