Nectin 4 Biomarker Testing For Oncology Clinical Programs

An emerging biopharma sponsor needed a fully validated Nectin-4 IHC assay to support patient selection in a solid tumor development program. The assay had to evaluate Nectin-4 expression in formalin-fixed, paraffin-embedded (FFPE) tumor samples. It also had to hold up under CLIA-grade testing and scale to hundreds of clinical samples. No fully validated, clinical-grade assay was available off the shelf. Precision for Medicine’s Winston-Salem Histology team took the work from antibody screening through analytical validation and clinical deployment inside a single facility.

The team evaluated multiple antibody candidates and used custom control tissues to benchmark assay performance. They optimized staining for clear membranous expression, the pattern pathologists need for scoring to be reproducible. The result was a CLIA-validated assay with regulatory-grade documentation and a scalable testing framework the sponsor can carry forward into future studies. Learn how to move from having no off-the-shelf assay to clinical readiness, without a build-from-scratch delay heading into enrollment.