Description
Multispectral digital skin lesion analysis [MSDSLA] is a noninvasive approach to diagnosing skin lesions; the technique has the potential to improve diagnostic accuracy for suspicious skin lesions and may increase the detection rate of malignant skin lesions and/or reduce the rate of unnecessary biopsies.
For individuals who have pigmented lesions being evaluated for melanoma who receive MSDSLA, the evidence includes 2 prospective diagnostic accuracy studies of MelaFind, a retrospective analysis of MelaFind in a clinical setting, and additional studies of other MSDSLA devices. Relevant outcomes are overall survival, disease-specific survival, test accuracy and validity, other test performance measures, and change in disease status. The diagnostic accuracy study found that MSDSLA had a sensitivity of 98.2% for recommending biopsy of melanoma lesions [8% of the pigmented lesions were melanoma]. The average specificity of MSDSLA was 9.5% compared with 3.7% among clinicians. However, the study only included lesions already determined by a clinician to be sufficiently suspicious to warrant excision. No prospective studies conducted in a clinical setting have evaluated the utility of MSDSLA as a diagnostic tool in the initial evaluation of pigmented lesions. In addition, given the absence of firm evidence about the clinical validity of MSDSLA, a chain of evidence cannot be built to support conclusions about the magnitude of benefits and harms of MSDSLA use in practice. The manufacturer discontinued support and commercialization of the MelaFind device in 2017. The evidence is insufficient to determine the effects of the technology on health outcomes.
Background
Melanoma is a form of skin cancer that originates in the pigment-producing melanocytes. Most
melanocytes produce melanin and the tumors are commonly pigmented brown or black. Melanoma is less common than basal and squamous cell skin cancer, but it is more likely to metastasize than other skin cancers. Prognosis is highly associated with stage of the disease at diagnosis, characterized by the depth of the tumor, the degree of ulceration and the extent of spread to lymph nodes and distant organs. For example, for thin [i.e.,