Sep 07, 2012
Cape firm’s breast-cancer diagnosis tool enters clinical evaluationBack
Cape Town|Design|Evans|Industrial|Industrial Development Corporation|System|University Of Cape Town|Equipment|Medical Imaging Equipment|Product|Products|Solutions|Venture Capital Investment|Breast Cancer|Kit Vaughan|Michael Evans|Medical Imaging|Ultrasound|X-ray
© Reuse this
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.
Edited by: Martin Zhuwakinyu© Reuse this Comment Guidelines (150 word limit)
Other News This Week News
Recent Research Reports
Defence 2014: A review of South Africa's defence industry (PDF Report)
Creamer Media’s Defence 2014 report examines South Africa’s defence industry, with particular focus on the key participants in the sector, the innovations that have come out of the sector, local and export demand, South Africa’s controversial multibillion-rand...
Road and Rail 2014: A review of South Africa's road and rail infrastructure (PDF report)
Creamer Media’s Road and Rail 2014 report examines South Africa’s road and rail transport system, with particular focus on the size and state of the country’s road and rail network, the funding and maintenance of these respective networks, and the push to move road...
Real Economy Year Book 2014 (PDF Report)
This edition drills down into the performance and outlook for a variety of sectors, including automotive, construction, electricity, transport, steel, water, coal, gold, iron-ore and platinum.
Real Economy Insight: Automotive 2014 (PDF Report)
This four-page brief covers key developments in the automotive industry over the past 12 months, including an overview of South Africa’s automotive market, trade figures, production and the policies influencing the sector.
Real Economy Insight: Construction 2014 (PDF Report)
This five-page brief covers key developments in the construction industry over the past 12 months. It provides an overview of the sector and includes details of employment in the sector, infrastructure and municipal spending, as well as insight into companies’...
Real Economy Insight: Electricity 2014 (PDF Report)
This five-page brief covers key developments in the electricity industry over the past 12 months, including details of State-owned power utility Eskom’s generation activities, funding and tariffs, independent power producers and prospects for the sector.
This Week's Magazine
The broad-based black economic-empowerment (BBBEE) alignment process in the con-struction sector has begun, dur-ing which the sector codes of the Construction Sector Charter Council (CSCC) will be aligned with the revised Codes of Good Practice (CoGP), which come...
It is second time lucky for Toby Venter. Ten years ago he negotiated to buy the Kyalami racetrack, but “the deal did not materialise”.
Environmental solutions company I-Cat started construction work on its R22-million, 1 949 m2 environmentally sustainable office and warehouse facility, commissioned by I-CAT Environmental Solutions, at a launch event in October. The new sustainable I-CAT campus,...
Effective file synchronisation and sharing across an organisation’s structures can provide the basis for robust mobile-device and document management while maintaining proper backup, version control and content distribution. These are the lessons learned by complex...
Hotel group Carlson Rezidor currently holds the largest hotel pipeline in Africa with 30 hotels and 6 300 rooms under development. The hotel group develops and operates Radisson Blu in the upper upscale segment and Park Inn by Radisson in the mid-market segment. With...