Study Demonstrates Accuracy of Orlucent’s Skin Fluorescent Imaging System

Researchers have confirmed through study results the accuracy of Orlucent Inc.’s Skin Fluorescent Imaging (SFI) System, a non-invasive, hand-held molecular imaging device for direct, on-the-skin, point-of-care assessment of suspicious moles and early melanoma-related detection. Trial results were published in this month’s edition of Journal of the American Academy of Dermatology (JAAD) International.

The study results validate the use of Orlucent’s SFI molecular method to improve diagnostic accuracy by helping physicians classify difficult-to-characterize moles and carries great potential to reduce unnecessary biopsies and identify aggressive cancers early compared to current clinical practice.

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

Melanoma is the most lethal form of skin cancer, often caused by ultraviolet exposure from sunlight or indoor tanning, and can progress to metastatic disease if not detected early. Clinical evaluation currently relies largely on subjective visual assessments of suspicious moles using the ABCDE criteria (asymmetry, border, color, diameter, and evolution).

However, many suspicious or “atypical” moles are not melanoma and, conversely, some melanomas lack the classic criteria, making these moles difficult to classify. To avoid missing an early melanoma, dermatologists follow a “when in doubt, cut it out” approach, performing an estimated 5 million to 10 million biopsies annually that lead to the identification of roughly 100,000 melanomas, resulting in substantial overtreatment, scarring, and unnecessary patient anxiety.

SFI delivers an objective measure of cellular activity for a mole, as opposed to relying on visual methods alone, reducing reliance on subjective visual assessment by healthcare professionals. This supports earlier detection of concerning moles, reduces excess biopsies, improves patient outcomes, and may lower melanoma mortality.

“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,” stated senior study author and investigator Sancy Leachman, M.D., of Oregon Health & Science University.

The clinical trial examined the use of SFI in 240 patients with difficult-to-diagnose moles (not obviously melanoma or benign), across six academic and community dermatology clinics in California, Utah, and Oregon. Among the key findings:

• SFI detected oncogenic activity in 100% of melanoma cases.
• SFI cutoff scores of 5 (where 5-10 is considered positive) or 7 (where 7-10 is considered positive) demonstrated sensitivities (true positive detection rate for melanoma, melanoma in situ and high-grade dysplasia) of 93% (5 cutoff) and 87% (7 cutoff) and specificities (true negative rate for no or low-grade dysplasia) of 77% (5 cutoff) and 91% (7 cutoff), respectively.
• SFI exhibited excellent overall diagnostic accuracy or Area Under the Curve (where 1 is perfect) at 0.907 (95% CI 0.864-0.951, P <.0001) demonstrating its potential as a highly effective tool for identifying concerning moles.
• When compared to the use of dermoscopy (a polarized magnifying glass), SFI performance was superior showing sensitivity of 89% vs. 53 %, and specificity of 94% vs. 61%.

SFI’s technology works by identifying the presence of αvβ3 integrin which is expressed in moles undergoing oncogenic tissue remodeling with the potential for metastatic disease at the earliest stage. The SFI test procedure includes application of a fluorescent peptide dye that binds to this αvβ3 integrin. A handheld imaging device captures the signal created and Orlucent Mole Analytics Software, powered by artificial intelligence and machine learning, analyzes it in real time. Use of SFI requires minimal training and results are available at the point of care within minutes.

The SFI System has received Breakthrough Device Designation by the U.S. Food and Drug Administration and is currently completing additional trials to support regulatory approval.

“Our goal is to make advanced molecular insight simple and accessible,” Orlucent Co-Founder/Chief Scientific Officer Catherine Shachaf, Ph.D., stated. “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.”

Orlucent has developed the first handheld fluorescent molecular imaging system to non-invasively evaluate early molecular changes that signal the likelihood of a mole’s transition to melanoma. It is the only system to reveal oncogenic activity without invasive biopsy and was developed in response to dermatology societies’ demand for new clinical tools to assist with evaluation of moles where more information is needed to rule out or rule in the potential of the mole developing into a melanoma, according to the company.