Key Highlights

  • Optiscan Imaging has imaged more than 80 cases in its digital pathology study with Australian Clinical Labs using its InForm platform
  • The study is being conducted within ACL's anatomical pathology laboratory in Western Australia across a range of tissue types and cancers
  • Cases assessed span multiple tissue systems including breast, gastrointestinal, respiratory, kidney, liver and skin, across normal, benign, premalignant and malignant pathologies
  • The data collected is intended to support workflow optimisation, pathologist Training and future regulatory submissions in Australia and the United States

Study Milestone Reached

Optiscan Imaging Ltd (ASX:OIL) has announced that its digital pathology study with Australian Clinical Labs (ACL) has successfully imaged more than 80 cases using the company's InForm platform. The study forms part of a Collaboration Agreement between the two companies, first announced in November 2025, and is evaluating the performance of InForm in a high-throughput pathology environment.

Study Design and Scope

The InForm device is being used within ACL's flagship anatomical pathology laboratory in Western Australia to perform real-time, slide-free cellular imaging at the point of contact. As at the date of the announcement, 84 cases had been imaged, spanning tissue samples across multiple systems including breast, head and neck, gastrointestinal, urinary, reproductive, respiratory, cardiovascular, endocrine, kidney, liver, prostate, eye and skin. The cases cover a range of pathologies, from normal and benign to premalignant and malignant, allowing the company to assess imaging performance under a range of clinical conditions. Tissue specimens processed through ACL's centralised laboratory are imaged in real time and evaluated by pathologists against conventional haematoxylin and eosin stained glass slides.

Partnership with Australian Clinical Labs

ACL operates a national network of more than 40 NATA-accredited laboratories, employing more than 60 RCPA-accredited pathologists and over 4,500 scientific, collection and support personnel, servicing patients through 1,273 collection centres. The Partnership provides Optiscan with access to an established pathology network for validation of its technology and refinement of how InForm integrates into existing laboratory workflows.

Regulatory and Commercial Significance

The company said the imaging data generated from the 84 cases provides an evidence base to support future regulatory submissions in Australia and the United States. In addition to demonstrating device performance across tissue types and cancers, the programme is contributing to the development of imaging protocols, validation datasets and pathologist training materials, which the company expects to form part of its broader regulatory and clinical rollout strategy. Optiscan also noted that the study is helping to optimise the InForm platform for routine clinical use ahead of a wider commercial rollout, and has established a reference site with a pathology provider that may support future commercial discussions.

Management Commentary

Optiscan CEO and Managing Director Dr Camile Farah said the milestone was reached just over six months after the device was deployed at ACL's Perth laboratory, and that InForm had generated high-resolution images across all soft tissue cancer types evident in the first 84 cases, recapitulating detail seen in standard glass slides. ACL Clinical Director Dr Marissa Muller said the milestone reflected the organisation's ongoing evaluation of the technology across a range of tissue types and clinical scenarios, with pathologists and laboratory scientists providing direct feedback on its potential integration into everyday workflows.

Conclusion

Optiscan Imaging's collaboration with Australian Clinical Labs has now generated imaging data from more than 80 cases spanning a range of tissue types and pathologies, providing the company with real-world clinical data intended to support its InForm platform's development, regulatory submissions, and future commercial deployment within pathology laboratory settings.