Case Study – DIRA Assay Testing For Daratumumab Clinical Trials

Discover in this case study how a daratumumab-Specific Immunofixation Electrophoresis Reflex Assay (DIRA) was developed using a mouse anti-daratumumab antibody, and evaluated for specificity, limit of sensitivity, and reproducibility.

Therapeutic mAbs interfere with patient assessments, giving the impression that the patient will remain sick and never get a complete negative immunofixation. This falsely affects the overall efficacy of the study drug. Therefore, the client was searching to create an assay that could circumvent this issue and can be used as a valid tool to identify the resolution of the disease and hence the efficacy of the drug.

Read the full case study and discover how our team of experts tackled this challenge