OneMark™ breast localisation: integrating diagnosis and surgical guidance-a narrative review

Wire-free breast localisation technologies have largely replaced wire-guided localisation and improved patient comfort and scheduling flexibility. However, most currently available systems retain a fundamental inefficiency: diagnostic biopsy and definitive surgical localisation remain separate procedural events. OneMark™ breast localisation proposes an alternative paradigm by integrating diagnostic marking and intraoperative localisation into a single step at the time of biopsy. This article evaluates whether such pathway efficiency represents a meaningful clinical advance or an unproven conceptual ambition.

This narrative review and critical appraisal examine the conceptual basis, proposed clinical applications, and pathway implications of the OneMark™ breast localisation system. Evidence was derived from publicly accessible U.S. Food and Drug Administration (FDA) clearance documentation, manufacturer-provided technical information, clinical trial registry data, and hands-on device evaluation by the senior authors using ex vivo breast tissue and a recently published cadaver-based simulation study assessing detection time and visibility. This informal ex vivo assessment was undertaken to familiarise the investigators with the technology and was not intended as a formal performance evaluation. No published peer-reviewed clinical outcome data are currently available.

OneMark™ employs a hydrogel marker containing Doppler-visible microparticles and a metallic clip, deployed at diagnostic biopsy and subsequently localised intraoperatively using surgeon-operated Doppler-based detection with visual and auditory feedback. The primary proposed advantage is pathway efficiency, eliminating the need for a separate pre-operative localisation procedure. Additional theoretical benefits include potential deployability across imaging-guided biopsy settings, including neoadjuvant systemic therapy, minimal magnetic resonance imaging (MRI) artefact, small marker size facilitating nodal deployment, and potential applicability in bracketing multifocal and extensive disease. Preliminary information suggests a lower cost compared with established wire-free localisation technologies. Preclinical cadaver-based simulation has demonstrated detection times comparable to standard biopsy clips and significantly superior visibility ratings, particularly for posterior lesions, with surgeons valuing audible Doppler feedback. However, clinical performance, reliability across anatomical sites, and oncological outcomes remain unvalidated.

OneMark™ represents a pathway-focused innovation that challenges the conventional two-step localisation model rather than offering incremental technical refinement. While the conceptual rationale is compelling, its clinical value remains contingent on prospective clinical validation evaluating successful localisation and margin positivity as primary endpoints. Until such data are available, OneMark™ should be regarded as a promising but clinically unvalidated technology with potential relevance to both high- and low-resource healthcare settings. A pragmatic pathway to adoption through structured clinical audit is proposed.