FDA approves Mela's melanoma device MelaFind Print E-mail
By Staff and Wire Reports   
Wednesday, 02 November 2011 08:28
FDA Approval CalendarCompany had been trying to get the device approved by the FDA since June 2009 and had filed a citizen's petition with the agency in May addressing the delay in the approval process.

 

The FDA approved the device for use on clinically atypical pigmented skin lesions with one or more clinical or historical symptoms of melanoma.

 The Food and Drug Administration on Wednesday approved the first-of-its-kind device, that makes detailed, digital images of skin growths and uses a computer to analyze them for signs of cancer, offering a sort of second opinion to doctors. The device is approved only for dermatologists and only for use on growths that don't have obvious signs of cancer but still have one or two worrisome traits.

The hope is to find more melanomas sooner. Nearly all patients diagnosed with early-stage melanoma can be treated and cured, but 85 percent of patients with late-stage melanoma die from it within five years.

More than 70,000 people in the U.S. will be diagnosed with melanoma this year, and 16 percent are diagnosed only after the disease has spread to other parts of the body, according to estimates from the National Institutes of Health.

"Every day patients come in with 20 moles on their back and the dilemma is, which ones are suspicious and need to be biopsied?" said Dr. David Pariser, former president of the American Academy of Dermatology. "The diagnosis of melanoma is the most serious one a dermatologist makes, and we have sleepless nights worrying about it," said Pariser, who consulted for the device's maker, Mela Sciences Inc. of Irvington, N.Y., on its presentation to FDA.

The device's handheld attachment, about the size of a blow dryer, emits light that penetrates below the surface of the skin, taking multicolored images that reflect the depth and shape of skin growths. A computer compares these to a database of 10,000 archived images and recommends whether a biopsy should be done.

In a company-sponsored study published last year involving around 1,300 patients, some with multiple growths, doctors reported that MelaFind correctly suggested biopsies on 125 of 127 melanomas that doctors had removed. However, the device did not raise an alarm about non-melanoma growths only about 10 percent of the time; that was still better than doctors in the study who correctly ruled out melanoma in less than 4 percent of such cases, on average. The study was published in the Archives of Dermatology.

The company's study was not intended to show that screening with the device saves lives, only that it can help improve a doctor's ability to spot melanoma.

For now, experts say MelaFind will help dermatologists make better decisions on which moles to remove.

"There is no such thing as 100 percent certainty in medicine," said Dr. George Elias, a melanoma expert at Georgetown's Lombardi Comprehensive Cancer Center who had no ties to the company or the device. "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."

Elias voted with the majority of an FDA panel that narrowly endorsed the device last year.

Dermatologists say it's too early to tell whether MelaFind will lead to fewer unnecessary biopsies.

"A biopsy takes a few minutes in my hands, so if there's an issue with any lesion we will always biopsy, whether we have a MelaFind picture or not," said Dr. Leonard Goldberg, a dermatologist at the Texas Medical Center and vice president of the Skin Cancer Foundation, a disease awareness group that accepts donations from makers of sunscreen.

"The FDA approval of MelaFind marks the most important achievement in the company's history and represents a significant advance for the millions of Americans who are at risk of developing this terrible disease," said Joseph V. Gulfo, MD, President and CEO, MELA Sciences. "We are actively working to prepare to launch MelaFind in the Northeast U.S. and Germany during the first quarter. We're planning a steadfast, deliberate and measured approach to the commercial launch to ensure that dermatologists in practices of all shapes and sizes are trained and set up to use MelaFind effectively on the patients who can benefit most from the objective information that the system provides during skin examinations."

In September, the company received CE Mark approval in the European Union, as well. Concurrent with its 2012 Northeastern U.S. rollout, the company plans to undertake a similar rollout strategy in Germany.

"We are thrilled that our years of persistence through the development and regulatory process have paid off," Dr. Gulfo continued. "We are ready to start this new phase in the company's history with the same energy, passion and tireless dedication that was responsible for this tremendous and rewarding accomplishment."




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