A breakthrough technology in molecular imaging and pathology is paving the way for a more objective approach to melanoma diagnosis.

By Andy Lundin

While skin biopsy with histopathology remains the gold standard for making melanoma diagnoses, advancements in in vivo testing are revolutionizing the noninvasive ways dermatologists can assess suspicious moles.

Dermatologists typically rely on visual cues to evaluate concerning moles using the subjective ABCDE criteria (asymmetry, border, color, diameter, and evolution). Fortunately, technological breakthroughs in molecular imaging and pathology are helping deliver a more objective approach to melanoma diagnostics.

A New Molecular Skin Fluorescence Imaging System

One new solution is the novel handheld point-of-care molecular Skin Fluorescence Imaging (mSFI) System that is being developed by Orlucent.

“Advancements in both molecular imaging and pathology form the basis for the Orlucent technology,” says Catherine Shachaf, PhD, president and chief scientific officer for Orlucent. “In vivo molecular imaging has been a research tool for quite some time and pathology has standardized the use of tissue stains as a means for assessing pathological features ex vivo. The Orlucent system has benefited from and combined both approaches to examine biological activity in moles in vivo.”

The mSFI approach uses a handheld imager and a 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, according to the company.

“While reducing the number of unnecessary biopsies, the Orlucent method will allow dermatologists to identify lesions of true concern that require further assessment through pathology, while monitoring those of less concern,” Shachaf says. “Using in vivo molecular imaging, one can evaluate the whole mole and its surroundings. And if the invasive procedure of biopsy is needed, the results of molecular imaging can also guide the dermatologist on the type and margins of a biopsy as well as provide biological information for the pathology evaluation.”

Further reading: Handheld Mole Imaging System Demonstrates Noninvasive Detection of Melanoma Activity

The Handheld Imaging Device

The U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for Orlucent’s Handheld Skin Fluorescence Imaging System back in May of 2023.

“The hand-held nature of the Orlucent device allows the test to be conducted in the clinic at the time of the visit and reduce patient anxiety by eliminating the wait time that comes with lab-based tests,” says Shachaf. “The small size allows for better storage and the ability to be incorporated in the clinical workflow.”

The company says it is preparing for FDA submission as it continues research of mSFI.

Andy Lundin is the associate editor of CLP.

Featured image: Orlucent’s handheld point-of-care molecular Skin Fluorescence Imaging (mSFI) System. Photo: Orlucent