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Analytical Validation of an Immunohistochemical 7-Biomarker Prognostic Assay (immunoprint ® ) for Early-Stage Cutaneous Melanoma in Archival Tissue of Patients with AJCC v8 T2-T3 Disease.
- Source :
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Diagnostics (Basel, Switzerland) [Diagnostics (Basel)] 2023 Sep 29; Vol. 13 (19). Date of Electronic Publication: 2023 Sep 29. - Publication Year :
- 2023
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Abstract
- Selected patients with early-stage melanoma have a "hidden high risk" of poor oncologic outcomes. They might benefit from clinical trials, and ultimately, if warranted by trial results, judicious everyday use of adjuvant therapy. A promising tool to identify these individuals is the immunoprint <superscript>®</superscript> assay. This immunohistochemical 7-biomarker prognostic test was clinically validated in three independent cohorts (N = 762) to classify early-stage patients as high-risk or low-risk regarding melanoma recurrence and mortality. Using College of American Pathologists (CAP) recommendations, we analytically validated this assay in primary melanoma specimens (N = 20 patients). We assessed assay precision by determining consistency of risk classification under repeated identical conditions (repeatability) or across varying conditions (reproducibility), involving separate assay runs, operators (laboratory scientists), and/or observers (e.g., dermatopathologists). Reference classification was followed by five analytical validation phases: intra-run/intra-operator, intra-observer, inter-run, inter-operator, and inter-observer. Concordance of classifications in each phase was assessed via Fleiss' kappa (primary endpoint) and percent agreement (secondary endpoint). Seven-marker signature classification demonstrated high consistency across validation categories (Fleiss' kappa 0.864-1.000; overall percent agreement 95-100%), in 9/10 cases, exceeding, and in 1/10 cases, closely approaching, CAP's recommended 0.9 level. The 7-marker assay has now been verified to provide excellent repeatability, reproducibility, and precision, besides having been clinically validated.
Details
- Language :
- English
- ISSN :
- 2075-4418
- Volume :
- 13
- Issue :
- 19
- Database :
- MEDLINE
- Journal :
- Diagnostics (Basel, Switzerland)
- Publication Type :
- Academic Journal
- Accession number :
- 37835839
- Full Text :
- https://doi.org/10.3390/diagnostics13193096