Evaluating the immunogenicity of biologics is a critical step in the drug development process. Non-clinical and clinical immunogenicity is evaluated via detection of treatment-induced anti-drug antibodies (ADAs). This assessment is often done using screening cut point determination through a multi-tier process. The screening cut point establishes the line between ADA negative and potentially positive samples. While there are well-established guidelines for determining the screening cut point of immunoassays [@RN15; @RN41], many tools are either incomplete or are not available for widespread use.
rADA is an R package that provides an open-source solution for screening cut-point determination that can be used to simplify the process of ADA detection as well as provide a framework for reproducibility and easily generate figures for reports.
rADA offers the following key features summarised in the diagram below.