Given the growing knowledge of diseases, personalized medicine is becoming the standard of care. As a result, the demand for diagnostics has never been greater. Medical professionals, regulatory agencies and payers alike call for definitive tests that can improve treatment outcomes, reduce exposure to toxicity and help control costs.

Earlier, in the first of this two-part series, Eric Groves, Jason Hill and Christopher Ung reviewed the increasing role of biomarkers in defining patient populations and measuring outcomes in oncology clinical trials. In this second paper of the series, they assess the passage from biomarker candidate to diagnostic entity and outline opportunities and pitfalls for biopharma sponsors along the way, with a particular focus on the regulatory requirement of the FDA.