British health-tech company Skin Analytics has launched the world’s first Class III regulated medical device technology to autonomously assess skin cancer from a smartphone.

Unlike existing skin check apps, DERM Zero provides dermatologist-level reassurance from a standard smartphone, without the need for a second review by a clinician. Skin lesions with no concern are definitively marked as ‘no further action needed’, while suspect lesions are flagged for medical assessment. The technology will allow skin cancer assessments to be performed in seconds in a primary care setting, without the need for a hospital appointment or specialist equipment. 

DERM (Deep Ensemble for the Recognition of Malignancy), the AI platform that powers DERM Zero, has been trained over 10 years on an extensive dataset of skin cancer images. The software has been used across 24 NHS hospitals over the last six years. More than 230,000 patients have been assessed and more than 20,000 cancers have been detected. 

Clinical trials

Clinical trials have shown that the underlying AI performs at least as well as face-to-face dermatologist assessment. A prospective, single-centre masked, non-inferiority, trial recruited patients referred to a teledermatology cancer pathway. Additional dermoscopic images of each suspicious lesion were taken using a smartphone with a dermoscopic lens attachment. The images were assessed independently by a consultant dermatologist and AI. The outputs were compared with the final histological or clinical diagnosis.

The study included 622 participants with 789 lesions. A total of 67 malignant lesions were identified, including eight diagnosed as melanoma. The AI sensitivity was set at 91 and 92.5 per cent to match the literature-defined clinician sensitivity (91.46%) as closely as possible. In both settings, the AI was significantly better at identifying lesions that did not need a biopsy and those that required urgent referral, with comparable sensitivity for skin cancer.

“Over six years, hundreds of thousands of patients and tens of thousands of cancers, Skin Analytics has supported our partners in delivering better skin cancer care. DERM Zero builds on those achievements and allows us to reimagine how patients access care with our partners. By enabling hundreds of millions of smartphones across the EU to conduct clinical quality skin cancer assessments we can fundamentally change patient access and we believe dramatically improve early detection,” said Neil Daly, Founder and CEO of Skin Analytics.

“We’re building new models of care with partners across Europe. This is the turning point when a skin cancer assessment will become as everyday as getting an ECG for AFib detection on a smartwatch. We see a world where no one dies of skin cancer, and this is how we get there.”

Dr Alexandra Kemp, Consultant Dermatologist and Trust Cancer Clinical Director at Amersham Hospital, part of Buckinghamshire Hospitals NHS Trust, said: “As a consultant dermatologist, I’ve assessed thousands of skin lesions for potential skin cancer. Since we first employed DERM in our skin cancer pathway, there has been a great impact on our clinical capacity, and it has made a real difference to the efficiency of the care we can provide.  When it comes to skin cancer, we know early diagnosis means better outcomes. To see this technology available on a smartphone, with no specialist equipment required, creates huge possibilities for expanding patient access and enabling earlier diagnosis.”