I never expected a dog show to be the inspiration for my next post, but nevertheless, that is exactly what has happened. When I switched on the TV recently, I was presented with Daisy the medical detection dog (MDD), a retriever who can sniff out cancer with striking reliability.
Can a dog be CE marked?
Being regulatory minded, I wondered whether Daisy and other MDDs were actually being used in the clinical setting and if so, were they regulated as traditional diagnostics? It seems a ridiculous question ‒ after all, how can a dog be CE marked? I still felt compelled to look into it, so I contacted the Medicines and Healthcare products Regulatory Agency, the UK regulatory authority for medical (in vitro) diagnostic tests. An MHRA spokesperson said: “[I] am sure these dogs would not come under our regulation. This is not something that I am aware has come to us in the past… [it] is not something we are looking at.”
Likewise, when asked whether these dogs were being used in the National Health Service, a Department of Health spokesperson told me: “I’m afraid this is not something that NICE [the National Institute for Health and Care Excellence] is involved in. As you know, NICE produces guidance, standards and information on health and social care.”
The science behind the sniffers
The science behind the dogs’ ability to detect the odour of cancer is believed to be linked to Volatile Organic Compounds produced by malignant cells, according to Medical Detection Dogs (aka Cancer and Bio-detection Dogs), the charity that trains the dogs and carries out research with them. “It has been established that during tumour growth protein changes in these cells which leads to peroxidation of the cell membrane components and this produces Volatiles that can be detected in the headspace of the cells,” the charity explains.
Where do we go from here?
In an interview with the BBC, Medical Detection Dogs chief executive Dr Claire Guest said that the research is at a very early stage and the next step would be a clinical trial with samples from local hospitals. She suggested that understanding how the dogs are able to detect the disease could pave the way for the development of an ‘electronic nose’ in future.
The charity was unavailable for comment in this post, but it has previously said that it has been trying to get government funding for some time now, with no success. Perhaps this is because it would be impossible to regulate these as ‘diagnostics’ in the traditional sense. It would be a shame that such a promising potential for early cancer diagnosis may never get off the ground due to regulatory limitations, especially when it could lead to technology that could easily carry a CE mark.