80 cases and counting — Optiscan’s InForm™ clears a landmark in real-world pathology testing
Optiscan Imaging Limited (ASX: OIL) has announced that its InForm™ digital pathology imaging device has now successfully imaged 84 cases at Australian Clinical Labs’ (ACL) flagship anatomical pathology laboratory in Western Australia, approximately six months after deployment. ACL is one of Australia’s leading private pathology providers, operating more than 40 National Association of Testing Authorities (NATA)-accredited laboratories and 1,273 collection centres nationally.
The cases span a broad range of tissue types, cancers, and clinical presentations, advancing three interconnected goals simultaneously: clinical validation, regulatory evidence generation, and commercial readiness.
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What InForm™ is doing inside ACL’s pathology lab
From glass slides to real-time digital images
In conventional pathology, a tissue specimen moves through a multi-step process involving tissue processing (which can take hours to days), glass slide preparation, and microscopic review before a diagnosis is reached. InForm™ replaces this sequence with real-time, slide-free cellular imaging that delivers digital images in 0–5 minutes, enabling immediate digital review and generating a permanent digital dataset alongside the diagnosis.
The workflow contrast, as detailed in the announcement, is significant:
- Conventional: Tissue removed → Tissue processing (hours to days) → Glass slides prepared → Microscopic review → Diagnosis
- InForm™: Tissue removed → Real-time cellular imaging (0–5 minutes) → Slide-free digital images → Immediate digital review → Diagnosis and permanent digital dataset
Critically, InForm™ has been able to generate high-resolution images of all soft tissue cancer types identified across the study’s first 84 cases, recapitulating standard haematoxylin and eosin (H&E)-stained glass slide detail.
The tissue range matters
The breadth of tissue types assessed across the 84 cases to date includes:
- Breast, head and neck, gastrointestinal, urinary, reproductive, respiratory, cardiovascular, endocrine, kidney, liver, prostate, eye, and skin
Pathology categories covered span normal, benign, inflammatory, premalignant, and malignant presentations.
A device validated across this spectrum carries a materially stronger regulatory and commercial profile than one tested within a narrow tissue category, as it demonstrates performance across the full range of conditions encountered in routine clinical practice.
Why this milestone moves the investment case forward
Building the regulatory evidence base
According to the FDA milestone roadmap included in the announcement (Figure 4), Optiscan is currently positioned at the Clinical Validation stage, with subsequent stages comprising Regulatory Dossier Preparation, FDA Submission, Regulatory Clearance, and Commercial Deployment.
The 84-case dataset is generating imaging protocols, validation datasets, and pathologist training materials that are expected to form part of Optiscan’s regulatory submissions in both Australia and the United States. The ACL data is a direct input into both regulatory pathways.
On the US side of the regulatory pathway, Optiscan’s Mayo Clinic breast cancer study opened recruitment for 35 patients in July 2026, with data from that cohort intended to directly support the planned FDA 510(k) premarket submissions for both InVue and InForm devices in H2 CY2026.
The ACL InForm data sits alongside a parallel breast cancer imaging study at The Royal Melbourne Hospital, which reached 25 of 50 target patients in June 2026 with early cases showing consistent concordance between Optiscan imaging and definitive histopathology and zero adverse events reported across the cohort.
Commercial deployment readiness
The collaboration has established a reference site with a nationally recognised pathology organisation, a critical asset in future commercial discussions with hospital laboratories and pathology providers. Real-world workflow integration feedback from ACL pathologists and laboratory scientists is directly informing platform refinement ahead of broader rollout.
Importantly, the study demonstrates compatibility with high-throughput, routine clinical laboratory conditions rather than controlled research settings, strengthening InForm™’s value proposition for prospective commercial partners.
Scalability signal
ACL’s network of more than 40 NATA-accredited laboratories, 1,273 collection centres, and more than 60 Royal College of Pathologists of Australia (RCPA)-accredited pathologists represents a validation environment that is representative of large-scale commercial deployment conditions. Performance within ACL’s ecosystem provides a meaningful de-risking signal for the pathway to broader adoption across comparable pathology networks.
| Workflow Stage | Conventional Pathology | Pathology with InForm™ |
|---|---|---|
| Initial step | Tissue removed | Tissue removed |
| Processing | Tissue processing (hours to days) | Real-time cellular imaging (0–5 minutes) |
| Image format | Glass slides prepared | Slide-free digital images |
| Review method | Microscopic review | Immediate digital review |
| Data output | Diagnosis | Diagnosis and permanent digital dataset |
What the study partners are saying
Dr Camile Farah, CEO and Managing Director, Optiscan
“Successfully imaging more than 80 cases through the ACL study since deploying the device at the pathology group’s flagship Perth lab just over six months ago is an incredible achievement. This milestone doesn’t just demonstrate the maturity and commercial readiness of our InForm™ platform. It also highlights the potential impact real-time cellular imaging can have in transforming pathology…”
“Results to date from the ACL study have materially advanced the clinical validation of our technology, particularly in terms of evaluating how InForm™ performs across a range of tissue types and disease settings. InForm™ has been able to generate high resolution images of all soft tissue cancer types evident in the study’s first 84 cases, recapitulating standard H&E-stained glass slide detail. For us, this isn’t just about testing a device, it’s about understanding how the technology may perform in the hands of pathologists and pathology technicians during their everyday work. That feedback is invaluable as we continue to refine the InForm™ workflow and prepare it for its wider clinical rollout…”
Dr Marissa Muller, Clinical Director, ACL
“Reaching more than 80 cases in this study marks an important milestone in our collaboration with Optiscan and reflects ACL’s commitment to innovation that has the potential to deliver meaningful benefits for patients, pathologists and laboratory teams…”
“Having InForm™ operating within our anatomical pathology laboratory provides a unique opportunity to evaluate real-time, slide-free cellular imaging in a genuine clinical environment. Importantly, our pathologists and laboratory scientists are able to assess the technology across a diverse range of tissue types and clinical scenarios, while providing direct feedback on its potential integration into everyday pathology workflows…”
“We are proud to be working alongside Optiscan and look forward to continuing to contribute our clinical and laboratory expertise as the technology progresses towards broader clinical application.”
What comes next for Optiscan and InForm™
The near-term focus for Optiscan centres on continuing to grow the case library, refining imaging protocols, and building out the regulatory dossier across both Australian and United States (FDA) pathways. Based on the FDA milestone roadmap detailed in the announcement, the logical sequence of steps ahead includes:
- Continued case imaging and data collection at ACL’s Western Australia laboratory
- Regulatory dossier preparation, incorporating imaging protocols, validation datasets, and pathologist training materials
- FDA submission
- Regulatory clearance
- Commercial deployment
Optiscan has stated that a key component of its overall development strategy is to make digital pathology more accessible, efficient, and clinically useful. The ACL collaboration is positioned to support that objective, with each additional case strengthening the evidence base underpinning both regulatory and commercial milestones ahead.
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