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
In the next 20 years, it was expected that, in Africa, more people would live in cities and towns than in rural areas, United Nations Habitat executive director Dr Aisa Kirabo Kacyira said at the Human Settlements Indaba that took place earlier this month in...
Tough-talking Human Settlements Minister Lindiwe Sisulu has committed government to building 1.5-million low-cost houses over the next five years, telling the Human Settlements Indaba in Johannesburg on Wednesday that the State would achieve this target through the...
Over the past 20 years there has been persistent concern about deindustrialisation in South Africa, as well as the fact that locally produced manufactured products have been increasingly displaced by imports.
Financial agreement for Ghanian independent power producer (IPP) Cenpower Generation Company’s $900-million, 350 MW combined-cycle gas-turbine power plant was finalised earlier this month, paving the way for the project’s construction to begin before 2015 in Tema,...
The revenue implications for South Africa of ‘base erosion and profit shifting’ by corporate taxpayers are firmly in the crosshairs of the Davis Tax Committee (DTC) and Judge Dennis Davis hinted last week that recommendations were being considered to “detect and...