Abstract
BackgroundThe elastic scattering spectroscopy (ESS) device (DermaSensor Inc., Miami, FL) is a non-invasive, painless, adjunctive tool for skin cancer detection. ObjectivesTo investigate the performance of the ESS device in the detection of melanoma. MethodsA prospective, investigator-blinded, multicenter study was conducted at 8 United States (US) and 2 Australian sites. All eligible skin lesions were clinically concerning for melanoma, examined with the ESS device, subsequently biopsied according to dermatologists’ standard of care, and evaluated with histopathology. A total of 311 participants with 440 lesions were enrolled, including 44 melanomas (63.6% in situ and 36.4% invasive) and 44 severely dysplastic nevi. ResultsThe observed sensitivity of the ESS device for melanoma detection was 95.5% (95% CI, 84.5%-98.8%, 42 of 44 melanomas), and the observed specificity was 32.5% (95% CI, 27.2%-38.3%). The positive and negative predictive values were 16.0% and 98.1%, respectively. LimitationsThe device was tested in a high-risk population with lesions selected for biopsy based on clinical and dermoscopic assessments of board-certified dermatologists. Most enrolled lesions were pigmented. ConclusionThe ESS device’s high sensitivity and NPV for the detection of melanoma suggest the device may be a useful adjunctive, point-of-care tool for melanoma detection.
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