The Orlucent system is a handheld point-of-care molecular-based imaging system designed to noninvasively identify and clinically assess the presence of biological tissue remodeling activity associated with the development of atypical moles in adults.

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Orlucent’s Skin Fluorescence Imaging System.

The Orlucent system is a handheld point-of-care molecular-based imaging system designed to noninvasively identify and clinically assess the presence of biological tissue remodeling activity associated with the development of atypical moles in adults.

The Orlucent system is designed to be used by physicians, in conjunction with traditional clinical visual skin examination as well as information on the patient's skin type and medical history, to help physicians determine a clinical course of action and identify melanoma at its very earliest stages.

"We are excited the FDA has recognized the Orlucent system as a Breakthrough Device," says Catherine Shachaf, Ph.D., president of Orlucent, in a news release. "It's estimated that anywhere from 2% to 53% of U.S. patients have moles that may be classified as suspicious, atypical, or dysplastic, and the Orlucent system will be an important tool to provide their physicians with information on a mole's biological activity status as well as its potential to become melanoma."

To use the Orlucent system for assessing an atypical lesion, a healthcare professional applies the reagent then uses the imager to capture both white light and fluorescent images. The system's image analysis software is used to analyze and display the images as well as provide a probability score for the presence of tissue remodeling.

A physician can use the Orlucent system's score along with their clinical assessment in determining if they should remove the mole and send it for biopsy or continue to observe the mole with the potential to retest it with the Orlucent system in the future.