Image: The MelaFind melanoma diagnostic tool (Photo courtesy of MELA Sciences).

A computer-assisted melanoma diagnostic tool helps the detection of atypical cutaneous pigmented lesions.

The MelaFind melanoma diagnostic tool is a point-of-care (POC) multispectral system with a handheld component that captures the image of a lesion with a dermoscope, through a thin layer of alcohol applied to the skin. Multiple light wavelengths are used to obtain data from images of suspicious pigmented skin lesions; the data are then analyzed against a proprietary database of melanomas and benign lesions stored on a central computer, using sophisticated algorithms. A report is then transmitted to the physician’s office containing a recommendation of whether the lesion should be biopsied.

The MelaFind is designed to be used only when a dermatologist chooses to obtain additional information for a decision to biopsy, and not to confirm a clinical diagnosis of melanoma. It is not intended to be used as a screening tool or in the evaluation of nonpigmented lesions; banal pigmented lesions; lesions considered definite melanomas; or mucosal, subungual, and other lesions at different anatomic sites. The MelaFind was developed by MELA Sciences (Irvington, NY, USA), and has been approved by the US Food and Drug Administration (FDA).

“There is no such thing as 100% certainty in medicine,” said George Elias, MD, a melanoma expert at Georgetown University (Washington DC, USA). “Ultimately it's the responsibility of the dermatologist to use his clinical judgment to make the best decision. This machine is there to help him, not replace him.”

The device was used by dermatologists in a pivotal study of 1,257 patients (mean age 47 years) on 1,632 pigmented skin lesions that had at least one characteristic of melanoma, which were also biopsied. Of the 114 lesions that were positive for melanoma on biopsy, 112 were tagged as positive by MelaFind, representing a sensitivity of 98.3%, compared to a sensitivity of 70% to 80% for dermatologists reported in the literature.

Melanoma is a malignant tumor of melanocytes. They predominantly occur in skin, but are also found in other parts of the body, including the bowel and the eye. Melanoma is less common than other skin cancers, but it is much more dangerous and causes the majority (75%) of deaths related to skin cancer. Treatment includes surgical removal of the tumor, adjuvant treatment, chemotherapy and immunotherapy, or radiation therapy. The chance of a cure is greatest when the tumor is discovered while it is still small and thin, and can be entirely removed surgically.

Guangzhou Jia Yu medical equipment Limited