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 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.
The 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.