Negative Predictive Value of Pigmented Lesion Evaluation by Multispectral Digital Skin Lesion Analysis in a Community Practice Setting

Objective: To determine if the high negative predictive value of a multispectral digital skin lesion analysis that has been previously found in an academic-based trial would be similar in a community-based setting with its expected different distribution of pigmented lesions. Design: Data were collected from patients undergoing routine skin examinations over a one-year period at a community-based practice in Florida. All lesions that were selected for biopsy to rule out melanoma were also imaged with multispectral digital skin lesion analysis prior to biopsy. Histopathological diagnoses and multispectral digital skin lesion analysis results were reviewed and compared with findings from a prior primarily academic center-based multispectral digital skin lesion analysis trial. Setting/participants: Community-based clinical setting in Florida. Measurements: Negative predictive value, sensitivity, and specificity. Results: One hundred thirty-seven consecutive lesions were selected for biopsy and also analyzed via multispectral digital skin lesion analysis. All 21 cases with multispectral digital skin lesion analysis “Low Disorganization” readings were all histologically benign (100% negative predictive value, 95% lower confidence boundary = 96.9%). The negative predictive value and the sensitivity were not significantly different than what was found in the prior academic-based multispectral digital skin lesion analysis trial. Multispectral digital skin lesion analysis also correctly identified all high-risk lesions, which were subsequently confirmed via histology to be one invasive melanoma and 15 moderately dysplastic nevi (100% sensitivity). Specificity with multispectral digital skin lesion analysis was significantly higher than reported in the academic-based multispectral digital skin lesion analysis trial (18% vs. 10%, p=0.02). Conclusion: Because of the high negative predictive value achieved by multispectral digital skin lesion analysis, lesions with readings of “Low Disorganization” may be considered for observation versus biopsy. Similar to what was noted in the academic center setting, multispectral digital skin lesion analysis may help dermatologists reduce the number of unnecessary biopsies while improving diagnostic accuracy.The incidence of melanoma is rising by approximately three percent each year.1 Dermatologists are faced with the challenge of diagnosing melanoma early as survival is indirectly proportional to time prior to intervention. Often, patients present with multiple suspicious pigmented lesions and differentiating which require biopsy from those that should be monitored complicates biopsy decision management for the clinician. In the evolving landscape of healthcare delivery in the United States, it is important to emphasize evidence-based practice that may increase biopsy efficiency. New technologies are emerging as tools for dermatologists to use in identifying suspicious lesions for biopsy and to enhance overall accuracy of biopsy decisions.2A multispectral digital skin lesion analysis (MSDSLA) (MelaFind®; MELA Sciences, Inc.) device is a noninvasive objective instrument that can aid dermatologists in determining which suspicious pigmented skin lesions should be biopsied to rule out melanoma.3 MSDSLA images and analyzes a pigmented skin lesion across 10 spectral bands of light (430-950nm) from the skin surface to 2.5mm in depth. Automated computerized analysis evaluates 75 unique features of pigment distribution within an atypical lesion to determine the level of morphological disorder and generate a classifier score (CS).3 A CS greater than or equal to 0 is considered to have “high” disorganization and scores less than 0 have “low” disorganization.The safety and effectiveness of MSDSLA were originally established from data analyzing 1,632 skin lesions collected by physicians at pigmented skin lesion centers of several major academic centers.4 In this primarily university-based study, a low disorganization finding was associated with a 98 percent negative predictive value (NPV).4 However, the frequency and distribution of pigmented lesions that are encountered at high-risk pigmented lesion clinics would be expected to be different than what is experienced in a community-based setting. The purpose of this study was to determine if the NPV using MSDSLA is similar in a community-based setting to what was described in the primarily academic pigmented lesion center study, thereby enabling the community-based clinician to choose to potentially follow versus biopsy those lesions identified as having low disorganization.