Cape Town-based developer of medical imaging equipment for breast cancer diagnosis CapeRay recently marked the launch of its full-field digital mammography system, the PantoScanner Soteria, at its facility in Westlake.

CapeRay itself was officially launched only two years ago after receiving a R15-million venture capital investment from the Industrial Development Corporation. However, research for the company’s PantoScanner platform has been ongoing for the last decade, starting at the University of Cape Town, from which CapeRay emerged.

Also highlighted at the event was the fact that CapeRay has been awarded ISO 9001 and ISO 13485 certification. The company received these certifications in July. The ISO 13485 certification is an international standard that specifies the requirements for a management system for the design and manu-facture of medical devices.

CapeRay’s Panto-Scanner platform is a dynamic concept for breast cancer diagnosis in that it combines full-field digital mammography, which is a technique that captures an electronic image of the X-rays transmitted through the breast, with automated breast ultrasound. While digital mammography improves diagnostic sensi- tivity (which means an increase in the percentage of true positives identified), the resulting mammogram can perform poorly if the breast tissue is dense. So, incorporating automated breast ultrasound is advantageous in that it allows an increase in the specificity of the diagnosis, which results in an increase in the percentage of true negatives identified.

CapeRay intends to produce and sell the PantoScanner in three variations, with the first being the entry-level system, Soteria, presented at the launch. The Soteria contains the Pandia digital X-ray camera, for which the company received CE Mark approval in July. The CE Mark recognises the camera’s compliance with the European Union’s Medical Device Directive and allows the Pandia to be sold on its own in any of the 27 European Union countries.

“Our first machine, the Soteria, is the first in a line of breast imaging solutions. By using slot scanning X-ray and our custom [Pandia] detector, it provides an image equivalent to other digital mammography machines on the market at lower dose,” explains CapeRay chief tech- nology officer Michael Evans.

According to Evans, the guiding design philosophy of the company has always been “less is more”, with an ongoing emphasis on designing a product that is simpler and easier to use, which, he feels, is something that has been achieved with the Soteria.

CEO Dr Kit Vaughan says the cost of securing only the ISO 13485 certifi- cation for the company and the CE Mark for the Pandia has been of the order of R1-million and the company is currently looking for further funding to complete commercialisation of the PantoScanner range of products.

However, for the immediate future, the Soteria will be entering a clinical evaluation at Groote Schuur hospital in September, which, Vaughan says, is “an exciting next step on our journey” as the data gathered is intended to form the basis of a CE Mark application for the entire Soteria system as well as an application for FDA approval.

Notably, CapeRay was also presented with a National Science and Technology Forum award in June, when it was judged the winner in the small to medium-sized enterprise category, which, Vaughan says, is a fine tribute to the innovative spirit and ‘can do’ attitude that pervades the company.

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