Melanoma Detection Device Gaining Approval

MelaFind receives FDA Approvable Letter

(RxWiki News) 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.

"Ask your dermatologist about MelaFind, a test may soon be available to detect melanoma."

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.

Review Date: 
September 27, 2011