Publication / Source: Bioanalysis 5(16)
Authors: Shawn Ciotti, Shobha Purushothama, Soma Ray (Biogen Idec, Inc.)
“…since every biomarker is different and each assay development comes with its own challenges, we are still in the process of learning. Collectively sharing our experiences of parallelism assessment will enhance our understanding of biomarker method development.”
Method development for biomarkers presents many potential challenges including: the absence of suitable reference material, suitable analytical reagents and matrix free from endogenous analyte. Collectively, these challenges can directly affect the quality of the bioanalytical data. Understanding exactly what is being measured and its biological relevance is critical in determining the limitations of the data generated using these assays .