DermaSensor Aids PCPs in Spotting Skin Cancer

New findings from the pivotal DERM-SUCCESS trial and a companion utility study provide strong clinical support for DermaSensor, a handheld skin cancer assessment device cleared for primary care by the US Food and Drug Administration in 2024.

“The DermaSensor device is an easy-to-use, point-of-care, hand-held skin cancer assessment device with high sensitivity and NPV for use in the primary care setting. Use of the device can help inform PCP decision-making about skin lesions suspicious for cancer, which need further evaluation and those that may be monitored,” wrote lead investigator Stephen Merry, MD, MPH, from Mayo Clinic.

DERM-SUCCESS

The DERM-SUCCESS study evaluated the diagnostic performance of DermaSensor, a noninvasive, elastic scattering spectroscopy device, for detecting melanoma and keratinocyte carcinomas in primary care settings. Conducted across 22 clinics in the US and Australia, this prospective, multicenter, blinded pivotal trial enrolled adult patients with skin lesions suspected of malignancy by primary care physicians (PCPs) between August 2020 and December 2021.

A total of 1579 lesions were evaluated, with histopathologic analysis confirming 224 cancers (14.2%). DermaSensor demonstrated an overall sensitivity of 95.5% (95% CI, 91.7% to 97.6%) and a sensitivity of 96.3% (92.9% to 98.4%) in patients aged 40 and older—the FDA-approved age group. Sensitivity by cancer type included 90.2% for melanoma, 97.8% for basal cell carcinoma, and 97.7% for squamous cell carcinoma. The device had a specificity of 20.7%, a negative predictive value (NPV) of 96.6%, and a positive predictive value of 16.6%, with a number needed to biopsy of 6.

Additionally, among patients aged 40 and older, DermaSensor misclassified 8 cancers, including 4 melanomas and 4 keratinocyte carcinomas, which represents 0.5% of total lesions and 3.7% of cancers biopsied.

DermaSensor’s Validation Study

In this study, 108 PCPs assessed 100 lesion cases—50 with and 50 without device output. For each case, physicians provided a diagnosis, a management decision, and rated their confidence before and after receiving device feedback.

Results showed that device assistance significantly improved diagnostic sensitivity from 71.1% to 81.7% (P = .0085), and referral sensitivity from 82.0% to 91.4% (P = .0027). While specificity declined slightly—diagnostic specificity from 60.9% to 54.7% (P = .1896) and referral specificity from 44.2% to 32.4% (P = .0256)—overall clinical performance improved. The area under the curve (AUC) for management decisions increased from 0.708 to 0.762, and for low-confidence cases, from 0.567 to 0.682.

Investigators also pointed out the proportion of physicians reporting high confidence in their management decisions increased from 36.8% to 53.4% with device support.

“I have spent most of my career researching and using skin cancer diagnostic tools. It has been a long-time unaddressed goal of the dermatology and primary care communities to have an easy-to-use tool that can provide an automated risk assessment for suspicious lesions,” said Laura Ferris, MD PhD, who is the Chair of Dermatology at UNC Chapel Hill, the lead author of this utility study, and a leading researcher on skin cancer diagnostic tools. “Now that DermaSensor is the first such tool available for PCPs and, given the clear device benefits that our study and others have demonstrated, I am optimistic for the impact this device will have on skin cancer detection and care.”

References:

1. DermaSensor. Published FDA Pivotal Studies Find DermaSensor has 96% Sensitivity and Cuts Physician’s Missed Skin Cancers by Half. DermaSensor. Published June 12, 2025. Accessed June 16, 2025. https://www.dermasensor.com/resource/published-fda-pivotal-studies-find-dermasensor-has-96-sensitivity-and-cuts-physicians-missed-skin-cancers-by-half/

2. Merry SP, Croghan IT, Dukes KA, et al. Primary Care Physician Use of Elastic Scattering Spectroscopy on Skin Lesions Suggestive of Skin Cancer. J Prim Care Community Health. 2025;16:21501319251344423. doi:10.1177/21501319251344423

3. Ferris LK, Jaklitsch E, Seiverling EV, et al. DERM-SUCCESS FDA Pivotal Study: A Multi-Reader Multi-Case Evaluation of Primary Care Physicians' Skin Cancer Detection Using AI-Enabled Elastic Scattering Spectroscopy. J Prim Care Community Health. 2025;16:21501319251342106. doi:10.1177/21501319251342106