WASHINGTON (AP) — 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.
MATTHEW PERRONE - AP Health Writer
AP Chief Medical Writer Marilynn Marchione
contributed to this report.
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