Orlucent® has developed the first handheld fluorescent molecular imaging system to non-invasively evaluate early tissue remodeling that signals the likelihood of a mole’s transition to melanoma.
FDA Breakthough Device
Desingation Granted
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The Orlucent System evaluates biological activity originating from within the mole
The Orlucent System non-invasively determines the likelihood of malignancy potential for suspicious moles to provide greater certainty in clinical assessments of indeterminate pigmented lesions.
Fluorescent biotag is topically applied then wiped away
Handheld imager captures white light and fluorescent images
The software provides a probability score for tissue remodeling
The novel Orlucent System detects a biomarker for early stromal tissue remodeling associated with mole transition from benign to atypia.
Fluorescent Biotag
Binds to Receptors
Imager CapturesFluorescence
Software Reports the Presence of a Malignancy Biomarker
Addressing physician desire for improved mole evaluation tools5-7 the Orlucent System was developed with the aim of increasing efficiency and reducing subjectivity and invasiveness in the identification of moles with potential to develop into malignancy. Orlucent is the first system to show biological activity without invasive biopsy and differentiate indeterminate pigmented lesions.
1. Friedman et al. The “dysplastic” nevus
2. Haenssle et al. Results of a surveillance programme for patients at high risk of malignant melanoma using digital and conventional dermoscopy
3. Annessi et al. Correlation between clinical atypia and histologic dysplasia in acquired melanocytic nevi
4. Elmore et al. Pathologists’ diagnosis of invasive melanoma and melanocytic proliferations: observeraccuracy and reproducibility study
5. March et al. Practical application of new technologies for melanoma diagnosis: Part I
6. Angelucci D. Diagnosis: Melanoma: What emerging tests and tech mean for dermatologists
7. Elmore et al. Pathologists’ diagnosis of invasive melanoma and melanocytic proliferations: observer accuracy and reproducibility study
Currently in Clinical Trials. Research Use Only in the US.
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