Dermatologists have no true test for determining if a skin lesion may be melanoma, the deadliest form of skin cancer. A new tool is gaining approval that will give physicians more reliable information to detect the disease when it’s most curable.
MelaFind, a noninvasive and objective computer-vision system designed to aid in detection of melanoma in its earliest stages, is one step closer to being available in the United States. Manufacturer, MELA Sciences, has announced that the U.S. Food and Drug Administration issued an Approvable Letter for Pre-Market Approval (PMA) application for the test.
While melanoma is the most serious form of skin cancer, when caught early, it’s nearly 100 percent curable. MelaFind can help dermatologists determine when a suspicious skin lesion needs to be biopsied, according to Darrell S. Rigel, M.D., Clinical Professor of Dermatology at New York University Medical School.
FDA action was based on a trial involving 1,383 patients and a companion study of 110 dermatologists. The device showed 98 percent sensitivity in detecting melanoma, while the dermatologists had a 72 percent sensitivity.
This step in the approval process allows the company to work with the FDA on finalizing labeling, packaging, training and clinical protocol for a so-called post-approval study. These steps then lead to final FDA approval for the device to be marketed and sold.
MelaFind recently received approval to be sold in all 27 nations of the European Union.
Each year an average of 53,000 new cases of melanoma are reported, with over 7,000 people dying from it. It is the sixth and seventh most common cancer among men and women, respectively.
Although melanoma is the least common type of skin cancer (basal cell carcinoma is most common), it is the deadliest, as it makes up only 4% of all skin cancers, but 79% of skin cancer deaths. Melanoma is caused by a cancer forming in a skin cell called a melanocyte, the type of skin cell that gives us skin pigmentation.