#5 Handheld Optical Scan for Melanoma

Overview

Skin cancer is the most common cancer in the United States, affecting millions each year. One in five Americans will develop this cancer in their lifetime. According to the National Cancer Institute, the incidence of melanoma, the least common but most lethal type of skin cancer, has been increasing for at least 30 years, mainly due to UV radiation from sunlight. More than 76,000 Americans develop melanoma annually and 9,000 are expected to die from it this year.

The survival rate of patients diagnosed with early melanoma is almost 99%, while survival for patients diagnosed with advanced stage cancer drops to about 15%. Annual costs for treating skin cancer in the United States surpass $3 billion. Therefore, early melanoma detection is critical and not just because it allows for more effective treatment options and higher survival rates, but also because there are fewer costly and invasive surgeries.

Melanoma can occur on any skin surface. It’s often found on the skin on the head, neck, and between the shoulders and hips in men; in women, it typically appears on the skin on the lower legs or between the shoulders and hips. When a dermatologist makes a visual assessment of a mole that looks unusual or has grown or changed color or shape recently, he or she will decide on doing a biopsy and removing a small piece of the mole or the entire mole. A pathologist then looks at the sample under a microscope to check for cancer cells.

The skin is the only organ entirely available to inspection and it can be looked at every day. Dermatologists are experts at analyzing the surface of the skin but detecting life-threatening melanomas with the human eye has its own set of challenges. Melanoma in situ and invasive melanomas often mimic benign lookalikes. This is compounded when a patient has many moles or suspicious spots on his or her body, which sometimes adds to the difficulty in deciding what needs to be biopsied.

Additional facts for a dermatologist means that a more informed decision can be made when having to decide whether to biopsy or not. There is now a new FDA-approved handheld office device for dermatologists that can provide that extra information needed to help these specialists in the identification of skin lesions that have characteristics of melanoma.

Without cutting the skin, the device—which uses imaging technology created by the military for guided missile navigation—is placed on the skin over the mole. Special lights of 10 specific wavelengths are shined on the skin, and the computerized system rapidly visualizes the micro-vessel structure of the lesion just below the skin’s surface. The device then uses sophisticated algorithms that objectively analyze the lesion. Next, the device compares the image findings it has just developed to a database of 10,000 archived images of melanoma and other skin diseases. In less than a minute, an assessment of the skin lesion is given and the dermatologist can then decide on possible next steps.

Where Are They Now

This device received FDA approval in 2011 and has been widely welcomed by the international skin specialist community. This technology is now being applied to scan for lung and brain tumors. Trials for these new applications are ongoing. Results from a trial of the handheld device in brain tumors were released in 2017 to show the technology demonstrated 97% accuracy, 100% sensitivity, and 93% specificity.

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