Optiscan Imaging (ASX:OIL) has announced the interim results of its oral imaging study conducted at the Australian Centre for Oral Oncology Research and Education.
The company said that the results show that the Optiscan technology is accurate for the diagnosis of oral cancer (squamous cell carcinoma) and pre-cancer (epithelial dysplasia).
The study assessed 47 patients presenting with 63 distinct oral mucosal lesions which were subjected to Optiscan’s real-time in vivo confocal laser endomicroscope (CLE).
CLE images were captured live during clinical examination with acriflavine and assessed for the presence of cytological and architectural features of dysplasia/carcinoma as determined by World Health Organisation diagnostic criteria.
The company said diagnostic accuracy was 88.9 per cent for the presence of dysplasia/carcinoma. Other performance metrics were sensitivity (Sn) 86.8 per cent, specificity (Sp) 92 per cent, positive predictive value (PPV) 94.3 per cent and negative predictive value (NPV) 82.1 per cent. It said 100 per cent of cancer cases were diagnosed correctly using Optiscan’s CLE device.
According to CEO and managing director Dr Camile Farah, “One of the study’s strengths was the inclusion of 3 blinded anatomical pathologists from Perth and Harvard University who reported the traditional histopathological findings of each biopsied lesion independently, and then provided a consensus definitive diagnosis to which the optical biopsy from Optiscan’s device was compared to. This is an extremely high hurdle to clear for diagnostic accuracy.”
Optiscan’s chairman Robert Cooke added, “The results from this interim study show that Optiscan’s fluorescence-based CLE device is a highly accurate, easy-to-use, rapid and slide-free point-of-care optical imaging technology for diagnosing oral cancer and precancer.”
The interim results are currently being used to develop machine-learning algorithms for use in computer-assisted diagnosis and telepathology applications in Optiscan’s partnership with Canadian-based Prolucid Technologies.
They will also support the company’s US FDA de novo classification application for its InVivage product intended for oral tissue imaging.