Verisante Technology has announced positive data from the Aura clinical study conducted by the University of British Columbia (UBC), Canada.
The study focused specifically on malignant melanoma, squamous cell carcinoma, basal cell carcinoma, actinic keratosis, and benign conditions that can visually mimic skin cancer.
The study authors took measurements on over 1,000 lesions from 848 patients. The results of the analysis showed that Aura had a sensitivity of 99% with a specificity of 17% in differentiating all major skin cancers from benign lesions. At a sensitivity of 95%, Aura's specificity increased to 41%. For melanoma versus benign lesions, Aura had a sensitivity of 99% with a specificity of 15%. At a sensitivity of 95%, specificity increased to 38%, the study authors said. The FDA previously required an endpoint sensitivity of 95% for a device that detects melanoma.
Verisante president and CEO Thomas Braun said these clinical results show that Aura will make a statistically significant difference in the detection of skin cancer. "Our evaluation of the statistical analysis by UBC is that the Aura will save lives and save money. The results indicate that using the Aura to assist in guiding clinical evaluations could potentially reduce the number of unnecessary biopsies by 50% to 100%," he added.
The Aura is designed as a tool to aid medical professionals in the assessment of suspect skin lesions for diagnosis as either skin cancer or a benign disorder. The non-invasive optical system uses Raman spectroscopy to biochemically analyse the skin, providing immediate results. The device will help to automate the current process of diagnosis, allowing rapid scanning of the 20 to 40 skin lesions on at-risk individuals, improving patient outcomes and comfort.
Verisante Aura is approved for sale in Canada, Europe and Australia.