However, early detection results in a high survival rate. The challenge is with mammographic screening – it is not widely available and current technologies pose resolution and detection issues.
X-rays, one of the technologies, provide a shadow image that overlays everything in the X-ray pathway, including potential tumours. Because some tumours have a similar density to surrounding breast tissue, it can make detection difficult.
The other technology is ultrasound, which uses high-frequency sound waves to generate an image. Although overlaying doesn't occur, the image isn't of a very high resolution.
CapeRay has developed an innovative system for breast cancer diagnosis. The PantoScanner combines digital X-rays and ultrasound images in a patented device that involves various branches of engineering, including biomedical, computer software, electronic, mechanical and industrial.
"The breakthrough technology platform enhances clinicians' ability to diagnose breast cancer by combining the best aspects of low dose X-rays and ultrasound through co-registering (combining and overlaying) the two types of images," says Dr Kit Vaughan, chief executive officer of CapeRay.
Although the X-ray scanner technology is already patented, there are pending patents to cover the integration of X-ray machines with ultrasound machines. Another innovation is the device's industrial design that considers end-user ease of use.
CapeRay is bringing three mammography devices to market. The entry-level digital X-ray system, Soteria, is equivalent to the competing products but with reduced radiation exposure.
Aceso, the mid-range system, is dual modality and incorporates X-rays and ultrasound within the same device. Vaughan says that this will offer one system with one price tag versus buying two separate machines. Previously ultrasound entailed the patient lying flat, which changes the breast shape. Aceso has been designed so that the woman remains in one position while both X-ray and ultrasound images are captured, thus allowing for the same breast compression and consistent imaging.
The top-range Aegle, in addition, offers 3D imaging. X-rays are taken from different vantage points and, through tomosynthesis (mathematical modelling), multiple slices of the breast can be shown. "The Aegle will allow us to capture both 3D X-ray and 3D ultrasound images," says Vaughan. Combining these images will create a complete 3D image for better detection.
CapeRay came about when De Beers approached the University of Cape Town (UCT) to develop alternative uses for a low-dose X-ray platform first created for the detection of stolen diamonds. With funding from the Innovation Fund, an initial company was created.
Further funding from the National Institutes of Health in the United States has allowed the team to focus on breast screening. In 2009, the Industrial Development Corporation (IDC) provided venture capital funding and CapeRay was created. Current shareholders include UCT, the founders (Vaughan, Michael Evans and Professor Tania Douglas), the IDC and an employees' trust.
Vaughan says there are huge opportunities for local companies to manufacture medical devices but it is extremely difficult to sell into South African hospitals. "This means there is little incentive even when the products are of an international standing."
Another challenge is the availability of certifying companies within South Africa. Currently prototype medical devices need to be sent overseas for testing at huge expense. "A better infrastructure that supports local companies would develop the market," says Vaughan.