Orlucent’s Handheld Imaging Device Shows High Accuracy for Non-Invasive Melanoma Detection

Orlucent, Inc. has announced new clinical trial results validating the performance of its Skin Fluorescent Imaging (SFI) System, a non-invasive, handheld molecular imaging device designed to assist with early melanoma detection. The findings were published in the February issue of JAAD International, a peer-reviewed journal of the American Academy of Dermatology.

The study, conducted across six academic and community dermatology clinics in California, Utah, and Oregon, enrolled 240 patients with moles that were difficult to classify visually. Researchers found that the SFI System detected molecular signs of melanoma activity in 100% of confirmed melanoma cases. Depending on the diagnostic cutoff used, the system demonstrated sensitivity rates as high as 93% and specificity up to 91%, offering improved diagnostic accuracy over traditional visual inspection methods.

"This is a major step forward for non-invasive skin cancer diagnostics," said Douglas Grossman, MD, of Huntsman Cancer Institute and lead author of the study. "Skin Fluorescent Imaging lets doctors see melanoma molecular activity in the skin, which may help reduce unnecessary biopsies and improve early detection."

Currently, dermatologists rely on the visual ABCDE criteria to assess suspicious moles, which can result in frequent biopsies due to diagnostic uncertainty. The “when in doubt, cut it out” approach is estimated to lead to 5 to 10 million biopsies each year in the U.S., though only about 100,000 of those identify melanoma. Orlucent’s technology aims to reduce unnecessary procedures and provide clearer direction for mole management at the point of care.

The SFI system operates by detecting αvβ3 integrin, a biomarker expressed during early oncogenic tissue remodeling. After applying a fluorescent peptide that binds to the biomarker, clinicians use a handheld imaging device to capture the signal. The accompanying AI-powered Mole Analytics Software analyzes the image data in real time and provides an immediate readout to inform clinical decision-making.

"This technology works like a molecular map for moles, revealing changes before they are visible to the eye and giving doctors more confidence about whether to biopsy a mole or monitor it," said Sancy Leachman, MD, of Oregon Health & Science University and senior author of the study.

The study also compared SFI with dermoscopy, a standard tool using magnification and polarized light. SFI demonstrated markedly better performance, with a sensitivity of 89% versus 53% for dermoscopy, and a specificity of 94% versus 61%.

Orlucent’s SFI System has received FDA Breakthrough Device Designation and is undergoing additional trials to support regulatory clearance.

“Our goal is to make advanced molecular insight simple and accessible,” said Catherine Shachaf, PhD, co-founder and Chief Scientific Officer at Orlucent. “SFI helps dermatologists move beyond surface features and understand what’s happening inside a mole, making the invisible visible and potentially catching aggressive changes earlier than ever.”