Optiscan Imaging (ASX:OIL) has announced the publication of readout results of its oral cancer imaging study conducted by Dr Camile Farah and his team at the Australian Centre for Oral Oncology Research and Education.
The study has been published in the Journal of Oral Pathology and Medicine. It highlights the accuracy of Optiscan's technology for diagnosing oral cancer and pre-cancer.
The study, commenced by Dr Farah before he joined the company as CEO and managing director, assessed a cohort of 47 patients presenting with 63 distinct oral mucosal lesions.
These participants underwent an optical biopsy using Optiscan’s real-time in vivo confocal laser endomicroscope (CLE).
The CLE images were captured live during clinical examination and assessed on-the-fly to provide an instant diagnosis based on cellular and architectural features indicative of oral epithelial dysplasia and carcinoma using World Health Organisation (WHO) criteria.
The study revealed a high diagnostic accuracy of 88.9 per cent for dysplasia or carcinoma, with a sensitivity of 86.8 per cent, specificity of 92 per cent, positive predictive value of 94.3 per cent, and negative predictive value of 82.1 per cent.
The company said that 100 per cent of cancer cases were accurately diagnosed using CLE in a clinical setting.
Dr Farah said, “The study demonstrates that Optiscan technology is effective and highly accurate in visualisation and identification of dysplasia/carcinoma of the oral mucosa. The decision to adopt a consensus procedure involving 3 blinded anatomical pathologists, establishes strong correlation and concordance between Optiscan’s CLE technology and traditional histopathology, affirming the excellent outcomes achieved through the clinical application of CLE. Importantly, utilisation of internationally accepted WHO diagnostic criteria of dysplasia for use with Optiscan’s CLE technology will undoubtedly lead to earlier adoption of its InVivage® device once cleared.”
Optiscan’s chairman Robert Cooke said, “The international publication of this study represents an important clinical milestone in demonstrating the viability of Optiscan’s technology. The near-perfect agreement with traditional consensus histopathology, achieved without the need for physical tissue biopsy in a diagnostic oral imaging setting, provides a multitude of benefits to the Company. In the near term, it will support the acceleration of our De Novo submission for InVivage. In the medium term, it will bolster our collaboration with Prolucid Technologies in the field of Artificial Intelligence and facilitate integration into our telepathology platform.”
Dr Farah added, “Not only does this publication show that the Optiscan technology is a viable and highly accurate point-of-care diagnostic approach to rapidly detect oral cancer and precancer in real-time, but looking ahead we envision coupling this with tissue biomarkers to drive advancements in molecular imaging for various clinical applications. We are excited about the future commercialisation of the Optiscan platform particularly as we cement our presence in the US and establish a new standard of precision surgery and digital pathology."