(RxWiki News) Detecting melanoma is still something of an art. While imaging technology exists, dermatologists most often rely on visual cues to assess if a mole or lesion appears to be cancerous. A new device is about to change that.
The U.S. Food and Drug Administration (FDA) has given pre-market approval (PMA) to MELA Sciences, the manufacturer of a computerized imaging system that provides objective analysis of suspicious moles to help dermatologists determine if and when biopsies are appropriate.
MelaFind is a smart device that has proven to be more accurate than doctors in the early detection of melanoma, the deadliest form of skin cancer that's curable when diagnosed and treated in its earliest stages.
"MelaFind will be available on a limited basis in the United States starting in 2012."
MelaFind differs from other imaging technologies that are essentially sophisticated cameras, according to Joseph V. Gulfo, M.D., President and CEO, MELA Sciences.
"This is a watershed moment for cancer detection," Dr. Gulfo old dailyRx. "This is a non-invasive, painless imaging system that's 100 percent objective. That is, no interpretation is needed," he explained
The hand-held wand is about the size of a hair dryer. It's moved over the suspicious lesion, and the system analyzes the area as "positive" or "negative." Some lesions may be determined to be "non-evaluable" in which case additional evaluation is needed.
"These results can then be incorporated into the physician's thinking and patient care to provide more efficient biopsies," according to Dr. Gulfo.
As part of the FDA approval process, MelaFind was tested with nearly 1,400 patients in a U.S. pivotal trial and a companion reader study of 110 dermatologists. The device was 98% accurate in the pivotal trial.
When compared to dermatologist judgments, the device had 98 percent sensitivity (accuracy) compared to doctors' accuracy of 72 percent.
Dr. Gulfo says the company plans what he calls a "deliberate rollout," meaning only 200 high-volume dermatology offices in the U.S. will be equipped with the systems. Each office will be carefully trained in the proper use of the technology.
Dermatologists will pay an initial placement fee of $7,500 and then individual usage fees of $50 for each digital reader card that contains patient information.
This service will not be reimbursed by insurers in the beginning, and the out-of-pocket fee patients will pay will be determined by the individual offices.