A novel engineering design for early diagnosis of breast cancer

During their lifetimes, one in eight women will be diagnosed with breast cancer. It is the number one killer of women aged between 40 and 55. Each year, two million new cases of breast cancer are diagnosed and, depending on the country, more than 40% of these women will die from the disease. There is some hope, though. If diagnosed early enough, breast cancer can be treated successfully.

Mammography – taking X-ray images of the breast – has been around since the 1960s and over the past 30 years screening mammography has saved many lives. Although it is considered the gold standard for screening, the technique does have one major drawback: it fails to detect early stage cancers located in dense breast tissue. This is a major problem since 40% of women have dense breasts and a missed diagnosis, known as a false negative, can have devastating consequences for the women concerned. It can take a further year or two before the cancer is detected, during which period the tumour may have grown rapidly in size and perhaps metastasised to other regions of the body. Not only will the treatment costs have escalated steeply, the prognosis for a successful outcome will have diminished significantly. The key to success, therefore, is early detection.

An ultrasound is an imaging modality that has been in clinical use for over half a century and, although lacking the spatial resolution of X-rays, it can penetrate dense breast tissue and thus detect malignant tumours. Recent research has shown that the addition of automated breast ultrasound as an adjunct to full-field digital mammography leads to a significant improvement in the percentage of true positive diagnoses.

However, this approach requires two separate imaging systems, increasing the cost substantially and requiring significantly extra time to capture the two separate sets of images.

CapeRay has developed a novel engineering design that combines the best of low dose X-rays and 3D ultrasound into a single device. This breakthrough technology thus co-registers the images from the two imaging modalities, significantly improving diagnostic accuracy in dense breasts. This innovative solution has been built on a platform known as the PantoScanner that will be produced in two models: a dual-modality system known as Aceso (the Greek goddess of healing) that integrates full-field digital mammography (FFDM) and automated breast ultrasound in one instrument; and an entry-level system known as Soteria (the Greek goddess of deliverance from harm) that is a standard FFDM device.

CapeRay owns various pieces of intellectual property, including a US patent for digital tomosynthesis (creating a 3D image of the breast using X-rays), and a design patent in the US and EU for a patient handle, while there are three patents pending in the UK, US and EU for its dual-modality technology that enables the fusion of X-rays and ultrasound.

To date, CapeRay has secured ISO 13485 certification, a CE Mark for its Pandia digital X-ray camera, and completed a successful clinical trial of its Soteria system at the world-renowned Groote Schuur Hospital. In addition, CapeRay’s engineers and medical collaborators successfully tested the breakthrough Aceso model in a clinical trial at the University of Cape Town in April 2014. By early 2015, the company will be ready to submit the technical files for Aceso and Soteria to its Notified Body, securing the CE Mark for both these products. FDA Approval in the US will follow later in 2015.

CapeRay management has been in discussions with various strategic international partners that will enable the company to bring its innovative platforms to market. Once the Aceso and Soteria systems have been widely deployed in breast centres, they will enable CapeRay to make a meaningful contribution to the successful treatment of South African women as well as women around the world.

Dr Kit Vaughn is the chief executive of Cape Ray

This article is part of a larger supplement. This has been paid for by the M&G‘s advertisers and the contents signed off by the organisers of the Innovation Summit

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