Critical Questions in Genomic Diagnostics for Veterinary Oncology: What We Need to Know

Abstract

ABSTRACT Genomic diagnostics are increasingly integrated into veterinary oncology practice, offering the possibility of refined approaches to tumour classification, risk stratification and therapeutic guidance through high‐throughput sequencing technologies. In human medicine, the clinical utility of genomic testing is underpinned by rigorous analytical and clinical validation, robust regulatory oversight and an expanding evidence base linking specific genomic alterations to disease phenotypes and therapeutic responses. In contrast, genomic testing in veterinary oncology remains underdeveloped, with limited standardisation, sparse species‐specific validation and frequent reliance on extrapolation from human data. This review delineates the current landscape of genomic testing in veterinary oncology, emphasising methodological considerations in assay design, validation requirements, and clinical interpretation. We highlight the need for analytical rigour, including the use of in silico and orthogonal validation strategies, and advocate for the establishment of performance benchmarks that account for assay sensitivity, specificity and reproducibility in relevant canine populations. In addition, we address the interpretive challenges posed by variants of uncertain significance and the limitations of inferring clinical actionability from human oncology frameworks. A critical, question‐driven approach is proposed to guide clinicians in evaluating the validity and applicability of genomic tests, focusing on test validation, intended clinical use and the functional relevance of identified alterations. Advancing genomic diagnostics in veterinary oncology will require coordinated efforts to improve transparency, expand validation cohorts and align clinical expectations with the current evidentiary base. These steps are essential to realising the full potential of precision medicine in veterinary oncology while maintaining scientific and clinical integrity.