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Skin Cancer

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Skin cancer is a type of cancer that occurs when there is an abnormal growth of skin cells, usually triggered by damage to the DNA within the skin cells. It is primarily caused by exposure to ultraviolet (UV) radiation from the sun or artificial sources like tanning beds. Skin cancer is the most common type of cancer worldwide, and its incidence continues to rise.
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Combining Reflectance Confocal Microscopy with Optical Coherence Tomography for Noninvasive Diagnosis of Skin Cancers via Image Acquisition

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DERM-SUCCESS FDA Pivotal Study: A Multi-Reader Multi-Case Evaluation of Primary Care Physicians' Skin Cancer

Laura K Ferris¹, Erik Jaklitsch², Elizabeth V Seiverling^2,3

¹Department of Dermatology, University of North Carolina, Chapel Hill, USA.

Journal of Primary Care & Community Health

|May 31, 2025

Summary

A new Elastic Scattering Spectroscopy (ESS) device significantly improved primary care physicians' (PCPs) ability to detect skin cancer, enhancing diagnostic sensitivity and management confidence. This AI-powered tool aids in evaluating suspicious lesions without biopsies.

Keywords:

artificial intelligence basal cell carcinoma diagnostic tools elastic scattering spectroscopy machine learning melanoma skin cancer squamous cell carcinoma technology

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Area of Science:

Optical diagnostics
Dermatology
Artificial Intelligence in Medicine

Background:

Elastic Scattering Spectroscopy (ESS) is an optical technique for in vivo tissue analysis.
It differentiates benign from malignant tissues, potentially avoiding surgical biopsies.
An AI-enabled handheld ESS device was developed to assist primary care physicians (PCPs) in managing skin lesions suspicious for cancer.

Purpose of the Study:

To evaluate the impact of an AI-assisted ESS device on PCP diagnostic and management performance for skin cancer detection.
To compare PCP performance with and without the ESS device's objective output.

Main Methods:

A clinical utility study involving 108 PCPs evaluating 100 skin lesion cases.
Cases were divided into two groups: 50 aided by ESS device output and 50 unaided.
PCPs provided diagnosis, management decisions, and confidence levels, both before and after device use.

Main Results:

Device-assisted evaluation significantly increased diagnostic sensitivity (71.1% to 81.7%) and referral sensitivity (82.0% to 91.4%).
Overall management performance (AUC) improved from 0.708 to 0.762 with device use.
Physician confidence in management decisions increased significantly, particularly for initially uncertain cases.

Conclusions:

The AI-powered ESS device significantly enhances PCPs' diagnostic and management sensitivities for skin cancer detection.
The device improves overall management performance and physician confidence in evaluating skin lesions.
ESS technology shows promise as an objective tool to aid PCPs in skin cancer management.