Nov. 2, 2011 -- MelaFind, a device that helps dermatologists decide whether to order a biopsy of suspected melanomas, has been approved by the FDA.
However, the device had a high false-positive rate. About 90% of the time, lesions identified as suspicious by the MelaFind device turned out not to be melanoma. But in the same clinical trial, a panel of dermatologists who did not use the device had an even higher false-positive rate.
Risks vs. Benefits
It was hoped that the device would reduce the number of unnecessary biopsies. At an FDA advisory panel meeting last year, some members worried that MelaFind's high false-positive rate actually would increase unnecessary biopsies.
In the end, the panel voted 8-7 in favor of FDA approval. Most members agreed that the benefits of MelaFind outweighed the risk of unneeded biopsies.
"MelaFind is a groundbreaking technology and represents one of the most significant advances in early melanoma detection," Darrell S. Rigel, MD, clinical professor of dermatology at New York University Medical School, says in a Mela Sciences news release. Rigel is a member of the company's scientific advisory board.
It takes years of training for a dermatologist to learn to identify the subtle signs of an early melanoma. MelaFind is intended to aid, but not replace, melanoma screening by expert dermatologists. It's approved only for use by professionals specifically trained to use the device.
A different device, the Aura from Verisante Technology Inc., recently was approved in Canada. The Aura device offers a biochemical analysis of skin lesions. It can be used to detect non-melanoma skin cancers as well as melanoma.
Verisante is seeking European and Australian approval before seeking FDA approval.