Immunogenicity means that a foreign substance such as an antigen induces an immune response in the body of a human or other animal. The occurrence of immunogenicity can have clinical effects such as PK (pharmacokinetics), efficacy, and safety. FDA/EMA regulatory agencies also recommend submitting data on immunogenicity measurement methods. Therefore, in order to successfully develop a therapeutic, a test method development strategy to search for and measure immune responses is essential, and setting a statistically appropriate cut point in the ADA test method plays an important role in ensuring acceptable sensitivity of the test to detect ADA. The test method mainly uses a Tiered approach that sequentially performs the Screening assay and the Confirmatory assay. We will introduce a JSL Script developed to output the Cut point estimate and results for each step in a single report using a typical blood sample dataset as an example.
