2019 PharmSci 360
The 2018 FDA BMV guidance shepherded biomarkers into a regulatory framework for non-clinical and clinical studies, and establishes assay validation criteria for use in regulatory decision making for safety and/or effectiveness or to support dosing instructions. In some cases, these same biomarkers are used as part of patient care within clinical trials. The US Clinical Laboratory Improvement Amendments (CLIA) law requires any testing related to patient care to be within its purview. Thus, the situation arises where some biomarker measurements must comply with both regulations. Or do they? Most labs supporting BMV do not have CLIA certification, and most CLIA labs are not compliant with the BMV. This is an area of growing debate as biomarker use within clinical trial drug development expands.