Cut-point Analysis for ADA Assays

Cut-Point Analysis for Anti-Drug Antibody Assays

Our team of expert statisticians are experienced in performing cut-point analyses for anti-drug antibody (ADA) assays. Our streamlined process based on the research of Devanarayan et al (2017)1 and regulator guidance2 provides robust, user-friendly results which significantly reduce the complexity of ADA assays compared to alternative methods.

ADAs can be produced by the body as part of an immune response to a biological drug. This is an undesirable outcome, as such a response can have negative effects on drug performance and even cause serious adverse effects. Understanding the immune response caused by a drug—its immunogenicity—is therefore an important component of ensuring its safety and effectiveness.

During preclinical and early clinical phases, ADA bioassays are used to determine the immunogenicity of a drug.  This involves testing for the specific binding of antibodies to the therapeutic protein. To identify the presence of ADAs in a sample, a cut-point—which represents the minimum assay response required to consider a sample positive—must be set. Previously, this was an involved statistical procedure which gave results that were challenging to use: cut-points often required corrections for individual analysts or pieces of equipment.

Quantics’ streamlined methodology, however, provides a single cut-point for each stage of an ADA assay. Choosing Quantics for your next cut-point analysis will, therefore, simplify your product’s path to licensing.

Figure 2: The screening cut point is deliberately chosen such that some negative tests move to the second phase of testing. This is to try and ensure all the screened-out tests are truly negative, while tests which are more borderline are screened out by the confirmatory test.