Blog

Introduction The January 2025 FDA Biomarker Assay Validation guidance suggests using PK validation approaches as a starting point. However, our extensive experience shows why quantitative range determination for biomarker assays demands a fundamentally different scientific approach. The Traditional Drug Assay Paradigm In drug concentration assays, establishing quantitative ranges follows a straightforward path: analysts confirm ranges…

Introduction The January 2025 FDA guidance suggests using PK validation approaches as a starting point, but our extensive experience implementing biomarker assays reveals why specificity and selectivity demand fundamentally different scientific approaches. Understanding Traditional Drug Assay Validation In drug concentration assays, specificity, and selectivity are demonstrated through straightforward spike recovery experiments. Specificity evaluates reference standard…

Introduction The January 2025 FDA guidance maintains consistency with previous documents in suggesting biomarker validation should start with approaches used for drug assays. However, our extensive experience in biomarker implementation reveals why accuracy and precision require fundamentally different scientific approaches. Understanding Traditional Drug Assay Validation In drug concentration assays, accuracy and precision benefit from a…

February 5th, 2025, 2:30 PM EST- Editorial Note: We have observed that the January 2025 FDA Biomarker Assay Validation guidance document referenced in this post is currently inaccessible through the provided URL (listed in the reference section at the bottom of this article). This development, while noteworthy, does not impact the scientific principles discussed here….