Optiscan to test real-time breast tissue sampling for instant identification of cancer cells

Over 20,000 Aussies are diagnosed with breast cancer every year and is the most commonly diagnosed cancer among women in the country. Therefore, early detection is crucial, and medical imaging is a large part of it. Given that, medical imaging tech provider Optiscan Imaging (ASX: OIL) is conducting a Breast Cancer Intraoperative Assessment study. 

The early results from examining preserved breast tumor and edge samples using the Optiscan system indicate that it can produce images similar to the traditional way of studying tissues to check for cancer and assess how much the tumour has spread into the surrounding area. These results were consistent in all 15 tumors that were studied, including different types of breast cancer, like invasive lobular carcinoma (the most common type of breast cancer) and invasive carcinoma NST (no special type).

Furthermore, the Optiscan confocal laser endomicroscopy (CLE) probe was able to tell apart healthy tissue from cancer-involved tissue in every case, just like what was initially seen and confirmed through traditional tissue examination. When they looked at fresh tissue, the images were of very high quality, and even when the tissue was preserved, the image quality remained good. The most important thing is that these images could be taken right at the patient’s bedside or in the pathology lab.

Optiscan CEO and Managing Director, Dr Camile Farah, commented, “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.” 

The study is being undertaken at the Royal Melbourne, Frances Perry and Epworth Hospitals. It 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 Optiscan, used during surgery, can instantly show if the edges of removed breast tissue have any cancer cells.

The imaging stage of the study comprised of 50 patients and 59 distinct tumours. Ex-vivo interoperative imaging (i.e. removing the tissue from the body before imaging it) was performed for all fresh tumours, while 12 patients with 15 distinct tumours also underwent imaging subsequent to tissue fixation and processing in the pathology laboratory. Initial data has revealed excellent correlation between Optiscan’s real-time CLE technology and traditional histological analysis. 

While traditional methods take hours and days to get results and can only analyse a fraction of the infected area, Optiscan’s technology provides real-time results and can be used for unlimited microscopic sampling.

Dr Farah adds, “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.” 

Optiscan’s technology could potentially lower the chances of breast cancer coming back after a lumpectomy (breast cancer surgery). This could improve the lives of these patients. Additionally, using CLE imaging could shorten surgery time by 25%, saving hospitals a lot of money, and potentially reducing the overall costs related to breast cancer recurrence by $9.9 billion.

After seeing positive results from the tissue imaging study, the Company is gearing up for a new study where it will use the CLE probe during actual surgeries to see how well it works in real-time. This information is crucial for creating a practical use case for doctors and to submit its application to the US Food and Drug Administration for breast cancer surgeries.

With cash in hand of only $875.3k in FY23, down from FY22’s $4.5 million, it is imperative that Optiscan go full steam ahead with its eyes on commercialisation.