Medical Device News

Orlucent Demonstrates Accurate, Non-Invasive Detection in vivo of Melanoma-Related Activity Using First-in-Kind Handheld Mole Imaging System

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First-in-human study

In a first-in-human study, researchers at Orlucent, Inc. have demonstrated the viability of a novel handheld point-of-care molecular Skin Fluorescence Imaging (mSFI) System to noninvasively identify and clinically assess the presence of biological tissue remodeling activity associated with the development of melanoma in adults.

The unveiling of this breakthrough in early skin cancer detection by Orlucent, an emerging medical device company focused on the clinical assessment of suspicious moles, is presented in a peer-reviewed article published in the January 2024 issue of the dermatology journal Pigment Cell and Melanoma Research.

mSFI technology

The mSFI technology has the potential to greatly improve the assessment of moles—also known as nevi—as well as the selection of which nevi are concerning and may be candidates for biopsy. Melanoma, the most lethal form of skin cancer, has long been a challenge to detect accurately, particularly those cases with the potential for aggressive behavior.

With the current standard of care, melanoma is identified in suspicious nevi using subjective visual clinical evaluations, during which the color, shape, and size of nevi are assessed using the ABCDE criteria (asymmetry, border, color, diameter, and evolution). When moles exhibit only one or two of these atypical features, discerning whether they could develop into melanoma becomes arduous. To avoid missing a melanoma, dermatologists rely on “when in doubt, cut it out” to manage moles which do not overtly classify as melanoma or benign — the “grey area” lesions — resulting in unnecessary biopsies, scarring and patient anxiety.

Not all moles presenting these atypical criteria are melanomas and, conversely, some melanomas do not present these criteria. The mSFI technology has the potential to reduce unnecessary biopsies of non-concerning moles while also identifying precancerous nevi with this tissue remodeling activity which would otherwise be dismissed as benign.

To validate this approach, researchers in a pilot clinical study examined 78 moles, of which 44 were confirmed by biopsy and histopathology as benign, 26 as atypical or dysplastic, and 8 as melanoma. mSFI separated melanoma from non-melanoma moles with a sensitivity of 100% (8 of the 8 melanomas tested positive) and specificity of 95.7% (67 of the 70 non-melanoma moles tested negative), demonstrating an ability to distinguish concerning from non-concerning moles.

Incorporating in vivo Molecular Imaging into Clinical Management

“Incorporating in vivo molecular imaging into clinical management opens new doors to objectively identifying suspicious moles with the potential of becoming melanoma or melanomas with the potential to be aggressive at the earliest stage,” said Catherine Shachaf, Ph.D., the corresponding author of the study and president of Orlucent. “Simultaneously, it can also help alleviate the anxiety linked to the uncertainty of conventional highly subjective diagnostic methods.”

Inventive mSFI Approach

The inventive mSFI approach utilizes a handheld imager and a specially designed, topically-applied fluorescent molecular peptide that illuminates and measures αvβ3 integrin – a biomarker protein associated with early invasive melanoma development. The integrin is an indicator for the presence of malignant cells and their interaction with the surrounding structural skin tissue during melanoma’s early progression. This “tissue remodeling” conveys the expansion of malignant cells into the surrounding tissue space, and the delivery of nourishment and oxygen.

The Orlucent system will be the first to provide clinicians with a noninvasive direct measure of early intra-cellular activity and shows promise to transform the landscape of identifying melanoma at its earliest stage. Accordingly, mSFI recently was recognized by the FDA as innovative medical technology, receiving the agency’s Breakthrough Device Designation.

Sancy Leachman M.D., Ph.D., who is Director of the Melanoma Research Program at the Oregon Health & Science University Knight Cancer Institute Not Involved in the Study comments….

“I am particularly excited about the ability of the Orlucent in vivo molecular Skin Fluorescence Imaging System to assess aspects of stromal tissue remodeling that are invisible to the human eye clinically through direct examination or traditional pathological examination of nevi, enabling the categorization of lesions of concern more accurately at a very early stage at the point of care. Further, it will diminish the need for unnecessary biopsies of ambiguous or ‘grey area’ lesions by equipping healthcare professionals with an additional tool to enhance clinical decision-making.”

Encouraged by these findings, Orlucent is continuing research of mSFI and is preparing for FDA submission.

Pigment Cell and Melanoma Research Peder-Reviewed Article

The peer-reviewed article in Pigment Cell and Melanoma Research is titled, “Molecular Skin Fluorescence Imaging: A Tool for Evaluating Early Melanoma Development,” and can be found at


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