Real-World Performance of a Noninvasive Cutaneous Melanoma Rule-Out Test: A Multicenter U.S. Registry Study

Mark Kaufmann, M. Skelsey, Laura Ferris, Michael Walker, Andrew Rigby, Burkhard Jansen, Loren Clarke
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Abstract

Introduction: Non-invasive adjuncts to visual assessment of pigmented lesions may reduce biopsies of benign lesions without compromising melanoma detection. A non-invasive genomic melanoma rule-out assay analyzes RNA extracted from stratum corneum cells for PRAME and LINC00518, two genes commonly expressed in melanomas but less often in benign lesions. This study sought to characterize performance of this test in a large patient cohort tested in the real-world clinical setting. Methods: The test was applied to suspicious pigmented skin lesions at 63 U.S. dermatology and primary care practices. Test results (positive / negative) were compared to pathology diagnoses (melanoma / not melanoma) for lesions that were biopsied and to follow-up visual examination for those that were monitored. Results: Of 19,653 total lesions evaluated, 17,858 (90.87%) tested negative. Biopsy results and / or follow-up examinations were available for 5,096 lesions, with median and mean follow-up duration of 352 and 341 days, respectively. For melanoma, sensitivity was 95.8% and specificity was 69.4%. Positive predictive value (PPV) was 13.4%, and NPV was 99.7%. For melanoma and ‘borderline’ lesions combined, sensitivity was 94.2%, specificity was 71.2%, PPV was 20.8%, and NPV was 99.3%. Conclusion: The results suggest this noninvasive test can facilitate distinction of melanoma from its benign simulators, increasing the proportion of pigmented lesions that can be safely managed with surveillance rather than biopsy and/or excision.
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无创皮肤黑色素瘤排除测试的实际效果:美国多中心登记研究
简介:对色素性病变进行肉眼评估的非侵入性辅助方法可减少良性病变的活检次数,同时又不影响黑色素瘤的检测。一种非侵入性基因组黑色素瘤排除检测方法可分析从角质层细胞中提取的 PRAME 和 LINC00518 RNA,这两种基因通常在黑色素瘤中表达,但在良性病变中较少表达。本研究试图通过在实际临床环境中测试的大型患者群来描述该检测方法的性能。检测方法在美国 63 家皮肤科和初级保健诊所对可疑的色素性皮肤病变进行了检测。将测试结果(阳性/阴性)与活检病变的病理诊断(黑色素瘤/非黑色素瘤)进行比较,并将监测病变的后续肉眼检查结果进行比较。结果共评估了 19,653 个病变,其中 17,858 个(90.87%)检测结果为阴性。有 5,096 个病变的活检结果和/或随访检查结果,随访时间的中位数和平均值分别为 352 天和 341 天。黑色素瘤的敏感性为 95.8%,特异性为 69.4%。阳性预测值(PPV)为 13.4%,NPV 为 99.7%。对于黑色素瘤和 "边缘 "病变,敏感性为 94.2%,特异性为 71.2%,PPV 为 20.8%,NPV 为 99.3%。结论结果表明,这种无创检验有助于区分黑色素瘤及其良性模拟物,从而提高可通过监测而非活检和/或切除术安全处理的色素性病变的比例。
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