Optiscan Imaging (ASX:OIL) has provided an interim readout on its Breast Cancer Intraoperative Assessment Study.
The study, currently undertaken at the Royal Melbourne, Frances Perry and Epworth Hospitals, involves a collaboration between Optiscan, breast surgeon Professor Bruce Mann, and pathologist Dr Anand Murugasu.
Supported by the Medical Device Partnering Program (MDPP), the primary objective is to determine if real-time intraoperative imaging of excised breast tissue using Optiscan technology can detect involved surgical margins.
The imaging stage of the study included 50 patients and 59 distinct tumours. Ex vivo interoperative imaging was performed for all fresh tumours, while 12 patients with 15 distinct tumours also underwent imaging after tissue fixation and processing in the pathology laboratory.
The company said initial data examining the correlation between Optiscan confocal laser endomicroscopic (CLE) imaging and that of conventional histopathology has revealed a positive correlation between Optiscan's real-time CLE technology and traditional histological analysis.
It said that an interim readout on fixed and processed breast tumour and margin samples shows that the Optiscan platform can provide images comparable to conventional histopathology for the determination of the presence of cancer and for the determination of tumour involvement in surgical margins.
Optiscan CEO and managing director, Dr Camile Farah, said, “The strong correlation and concordance of Optiscan technology to histopathology provides another strong indication for the utility of our unique digital CLE technology in breast surgery, as an adjunct in supporting clinical decision making in the operating theatre in the context of breast cancer margin analysis. Additionally, it paves the way for an ex vivo approach to assess fresh or fixed tissue with standalone in vitro diagnostic platforms which we are developing.”
Dr Farah added, “Breast conserving surgery is a complex challenge for health systems, with over 175,000 lumpectomies performed in the US alone and evidence revealing a re-excision rate of up to 35%. The utility of our slide-free, biopsy-free real-time imaging technology presents an exciting opportunity in this modality. We look forward to completing the analysis of the Study with Prof. Mann in collaboration with the broader research team, pursuing appropriate publications, and advancing efforts to develop a new surgical device for this highly addressable market in parallel to a standalone in vitro pathology device.”