Pigmented Lesion Assay to Improve Biopsy Specificity of Melanoma Diagnosis

Pigmented Lesion Assay

New study reports that use of a noninvasive pigmented lesion assay can improve biopsy specificity, which may allow dermatologists to miss fewer melanomas while reducing the number of benign lesions biopsied.

The utility study demonstrated that even pigmented lesion experts surgically biopsy about half as often and miss fewer melanomas when adding the pigmented lesion assay to their decision process. “We are excited to offer this noninvasive tool to aid dermatologist in the difficult diagnosis of melanoma,” said researcher Laura Korb Ferris, MD, PhD, associate professor of dermatology at the University of Pittsburgh. The study was published in JAMA Dermatology journal in October 2017.   

As a part of the web-based study, 45 board-certified dermatologist familiar with pigmented lesion management each 60 clinical and dermoscopic images of clinically atypical pigmented lesions suggestive of melanoma. The images were reviewed without and with noninvasive pigmented lesion assay gene expression information and were then asked if the lesions should be biopsied. The researchers collected data between March 24, 2014, and November 13, 2015.

There were 581 fewer decisions to biopsy benign lesions of a total of 2,340 decisions when PLA was introduced. The dermatologists improved their mean biopsy sensitivity from 95% to 98.6% (P = .01) when they incorporated the PLA into their decision whether to biopsy. The mean biopsy specificity increased from 32.1% to 59.9% when the PLA data were used, resulting in statistically significant difference between the readers’ mean pre-PLA and post-PLA specificity (< .001).

According to Pigmented Lesion Treatment Market report published by Coherent Market Insights, pigmented lesions on exposed skin can be a symptom of skin cancer. Researchers concluded that, although the data obtained support the clinical utility of the PLA, implications on clinical care will be determined through increasing adoption of the test. Implications on clinical care are likely to be primarily influenced by the nature and location of the pigmented lesion in question and the need to obtain lesion information beyond clinical or dermatopathology-based image and pattern recognition.

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