|Doctors are questioning the benefits of Mela Sciences' MelaFind device.--Courtesy of Mela Sciences|
When Mela Sciences ($MELA) won FDA approval for its cancer-identifying device back in 2011, the company hailed its technology as a huge advance in melanoma detection. But now, as MelaFind makes its way into U.S. hospitals, some physicians are concerned the device offers no benefit over low-tech tradition.
As The New York Times reports, some dermatologists worry that the use of MelaFind is giving doctors false surety in diagnosing melanoma, as the device is designed to vet small spots and not large melanomas or basal and squamous cell carcinoma.
In the pivotal trial Mela used to win the FDA's favor, the device charted 98% sensitivity in a study of 1,383 patients, compared to 72% for dermatologists alone. However, some biostatisticians told the Times that MelaFind's high recognizes a high percentage of melanomas because skyward sensitivity also falsely IDs benign tissue, possibly leading to unnecessary biopsies.
"My concern with MelaFind is that it just says everything is positive," biostatistician Jason Connor told the Times. "I don't think this helps an aggressive doctor, and unaggressive doctors could do just as well if they were more diligent without the device."
But that low threshold for positive identification is by design, a Mela spokeswoman told the newspaper. MelaFind is designed as a supplementary test for melanoma, not a unilateral diagnostic, and the device is calibrated to ensure it doesn't miss any cancerous tissue, even at the cost of some false positives, she said.
Of course, that feeds back into the initial concern: At $10,000 a pop, why should hospitals pay for a device that solely supplements the medical talent they already employ? Mela insists that the added insight from its algorithm-powered device is a benefit to dermatologists who want all the information they can gather before making a treatment decision, and one doctor who uses the device regularly told the Times it provides a valuable counterpart to her expertise.
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