From The Stage

Platform Spotlight: ImmunoCAP to Support Diagnosis of Allergic Reactions Against Biologics

Posted by / / Bioanalytical Platforms, Immunogenicity

The observation of drug-specific IgE antibodies which may cause anaphylaxis prompts the need to test for these antibodies - but because IgE are 2000-fold less prevalent than IgG antibodies, a very sensitive detection method is required. We discuss why the ImmunoCAP platform provides an ideal system to analyze IgE-mediated drug hypersensitivities.

510K Approved Assays vs. RUO Assays: Which Best Support Clinical Trial Biomarker Studies?

Posted by / / BioAgilytix Insight, Biomarkers

The answer to the question is “it depends”. Commonly a combination of 510K approved kits (in Europe known as assays that need to follow IVD-directive 2017/746) and research use only (RUO) kits are used to support the biomarker analysis needed in clinical trials because both types of assays have different strengths and limitations. To select the appropriate kit requires an understanding of these pros and cons in the context of the intended study the assay must support.