New device uses light to screen for melanoma

MATTHEW PERRONE

AP Health Writer

WASHINGTON — Der­ma­tol­o­gists will soon get some high-tech help decid­ing which suspicious-looking moles should be removed and checked for melanoma, the dead­liest form of skin cancer.

The Food and Drug Admin­is­tra­tion on Wednes­day approved a first-of-its-kind device, called MelaFind, 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.

To diag­nose the dis­ease, doc­tors decide which moles to remove and biopsy using an entirely visual set of guide­lines involv­ing size, shape and color. Most der­ma­tol­o­gists eas­ily spot late-stage lesions that have obvi­ous signs of can­cer, includ­ing irreg­u­lar edges, uneven color and a width greater than 6 mil­lime­ters. But many oth­ers are tough calls.

“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.

MelaFind under­went a con­tentious, years-long review by the Food and Drug Admin­is­tra­tion, which ini­tially rejected the device and con­cluded it could “poten­tially cause more harm than good.”

Reg­u­la­tors wor­ried that the device could give physi­cians a false sense of cer­tainty, lead­ing to fewer biop­sies. Another con­cern was that doc­tors could mis­in­ter­pret the device’s feed­back, par­tic­u­larly error mes­sages when a mole can­not be scanned. About 8 per­cent of growths scanned in the com­pany study came back as “unevaluable.”

At a meet­ing last fall, FDA sci­en­tists said Mela Sci­ences had not shown how its device would influ­ence day-to-day deci­sions by doc­tors. The agency also wor­ried about its use by gen­eral doc­tors not accus­tomed to iden­ti­fy­ing sus­pi­cious skin moles. Despite these con­cerns, the panel of advis­ers nar­rowly backed the over­all safety and effi­cacy of the device in a 8–7 vote.

Reg­u­la­tors said this week that they ulti­mately approved the device after Mela Sci­ences agreed to limit its use to board-certified der­ma­tol­o­gists who undergo a spe­cial­ized train­ing course.

“The device is only good for cer­tain lesions, and that’s why you have to be a der­ma­tol­o­gist to be able to clas­sify and cat­e­go­rize those lesions appro­pri­ately,” said Christy Fore­man, direc­tor of FDA’s Office of Device Evaluation.

Fore­man said an FDA-required follow-up study would help deter­mine how much of a ben­e­fit MelaFind rep­re­sents for patients.

“This device rep­re­sents new tech­nol­ogy. At the end of the day I don’t know that this will be the best tech­nol­ogy out there, but it is a step for­ward to allow con­tin­ued inno­va­tion in this area,” Fore­man said.

But don’t expect to see a MelaFind machine at your next doctor’s appoint­ment. The com­pany plans a lim­ited roll­out next year of just 200 der­ma­tol­o­gists on the East coast, all of whom must undergo com­pany train­ing before they can begin using the device.

Doc­tors will pay a one-time fee of $7,500 to lease and receive train­ing on the device. Patients will pay $150 out of pocket for a MelaFind scan, which ana­lysts say may limit use to more afflu­ent patients who are will­ing to pay extra for the lat­est med­ical care. Mela Sci­ences does not plan to ask insur­ers to cover the device until sev­eral years from now, after it is more widely used.

Mela Sci­ences orig­i­nally devel­oped the tech­nol­ogy to guide mil­i­tary weapons sys­tems. But the com­pany changed course in the mid-90s after con­sult­ing with der­ma­tol­o­gists, adapt­ing its tech­nol­ogy for melanoma detection.

Posted by AP News on Nov 2 2011. You can follow any responses to this entry through the RSS Feed. Comments can be made below.