Joint FDA Studies Show DermaSensor Device Reduces Missed Skin Cancers in Primary Care by 50%
FDA-cleared DermaSensor device shows 96% sensitivity and reduces missed skin cancer diagnoses by 50% in primary care, according to new data.
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Results from 2 pivotal clinical studies evaluating DermaSensor—a noninvasive, point-of-care skin cancer assessment device—demonstrate that the tool significantly improves primary care physicians’ (PCPs) ability to detect and manage suspicious skin lesions. Findings from both studies were published in the Journal of Primary Care and Community Health and support the use of DermaSensor in frontline settings for skin cancer triage.1
DermaSensor uses elastic scattering spectroscopy (ESS) to analyze cellular and subcellular structures in skin lesions. The FDA-authorized handheld device provides an immediate, automated malignancy risk assessment, allowing PCPs to identify lesions that warrant specialist referral.1
The first study was a multicenter validation clinical trial led by Mayo Clinic. Researchers enrolled 1005 patients with 1579 skin lesions who were evaluated across 22 primary care sites. Of these, 224 lesions were confirmed as skin cancers via dermatopathology, including melanoma, basal cell carcinoma (BCC), and squamous cell carcinoma (SCC). The ESS device demonstrated2:
- Sensitivity: 96% for skin cancer detection
- Negative Predictive Value (NPV): 97% for benign lesions
- Positive Predictive Value (PPV): Ranged from 6% (score = 1) to 61% (score = 10)
The device exceeded the 90% minimum sensitivity threshold set by the US FDA for melanoma detection, aligning with published dermatologic standards.2
“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 study authors led by Stephen Merry, MD, MPH, from Mayo Clinic.2
The companion clinical utility study included 108 PCPs to evaluate how ESS device use affected skin cancer management. Results showed3:
- Correct referral rate with device: 91.4%
- Correct referral rate without device: 82.0%
- Relative reduction in missed cancer referrals: 50% (from 18.0% to 8.6%)
These findings suggest that DermaSensor not only enhances cancer detection but also optimizes referral accuracy, potentially reducing unnecessary biopsies and missed malignancies.3
The device may fill a critical diagnostic gap for primary care, where providers often lack dermoscopy training and face challenges in evaluating ambiguous skin lesions. With skin cancer accounting for more annual cases than all other cancers combined, improved early detection could lower mortality and health care costs associated with delayed diagnosis.1
References:
1. Published FDA Pivotal Studies Find DermaSensor has 96% Sensitivity and Cuts Physician’s Missed Skin Cancers by Half. DermaSensor. Press release. June 12, 2025. Accessed June 12, 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. Journal of Primary Care & Community Health. Published online June 5, 2025. 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. Journal of Primary Care & Community Health. Published online May 30, 2025. doi:10.1177/21501319251342106
