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Pigmented lesion assay improves biopsy specificity in diagnosing melanoma

The use of a noninvasive pigmented lesion assay significantly improved biopsy specifity, which may allow dermatologists to miss fewer melanomas while reducing the number of benign lesions biopsied, according to study results recently published in JAMA Dermatology.  

“The utility study demonstrates 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,” researcher Laura Korb Ferris, MD, PhD, associate professor of dermatology at the University of Pittsburgh, stated in a press release from DermTech. “We are excited to offer this noninvasive tool to aid dermatologist in the difficult diagnosis of melanoma.”

Laura Korb Ferris

Ferris and colleagues conducted a web-based study in which 45 board-certified dermatologists familiar with pigmented lesion management each evaluated 60 clinical and dermoscopic images of clinically atypical pigmented lesions suggestive of melanoma. The dermatologists reviewed the images without and with noninvasive pigmented lesion assay (PLA, DermTech) gene expression information and were then asked if the lesions should be biopsied.

A report for each lesion, including the results of an assay for expression of LINC00518/PRAME and a PLA score with data on the predictive values of the information were provided to the dermatologists.

The researchers collected data between March 24, 2014, and Nov. 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 (P < .001).

“The described noninvasive gene expression test enables dermatologists to almost double biopsy specificity, the primary objective, while missing fewer melanomas,” the researchers wrote. “These findings suggest that providing gene expression information may lead to a true change of behavior.”

“Although the data obtained support the clinical utility of the PLA, implications on clinical care will be determined through increasing adoption of the test,” the researchers concluded. “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.” – by Bruce Thiel

Disclosure: Ferris reports serving as a consultant to DermTech. Please see the study for the other researchers’ relevant financial disclosures.