Device to Help in Detecting Melanoma Approved by FDA
A device called MelaFind has been approved by the FDA with the hope that it will help doctors in detecting more melanomas sooner.
Early detection is crucial for this type of skin cancer, as it is often curable when found early. If not, it is one of the most deadly types of cancer. According to the National Institutes of Health, over 70,000 people in the United States will be diagnosed with melanoma this year, and 16 percent are diagnosed after the disease has spread to other parts of the body.
MelaFind will help doctors decide whether or not to order a biopsy of suspected melanoma. The device has a handheld scanner and a computer program for analyzing images of skin lesions. It missed only 2 percent of biopsy-proven melanomas in a clinical trial.
One of MelaFind’s drawbacks is its high false-positive rate. Around 90 percent of the time, lesions that MelaFind finds suspicious are not melanoma. However, in that same trial, dermatologists who were not using MelaFind had an even higher false-positive rate.
While there were hopes that MelaFind would lower the number of unnecessary biopsies, some members of the FDA advisory panel were concerned it would increase the number, because of the high false-positive rate. However, the panel voted for approval because most members felt that the benefits outweighed the risk of unnecessary biopsies.
MelaFind won’t be replacing dermatologists — it’s a tool to help them with melanoma screenings. It is approved only for use by dermatologists who take a specialized training course.
Mela Sciences plans to roll out MelaFind to about 200 dermatologists on the East Coast next year.
Learn more about skin cancer reconstruction in Medina, Ohio.
Comments are closed.