Melafind is a highly anticipated device that had just received FDA approval. It is a noninvasive handheld device that evaluates suspicious pigmented lesions for need to biopsy.
Melafind System
According to the company Web site, MelaFind acquires and displays multispectral digital images from blue to near-infrared, for pigmented skin lesions. The computerized device uses automatic image analysis and statistical pattern recognition to help identify lesions that should be considered for biopsy to rule out melanoma. The device consists of an illuminator that produces light in 10 wavelengths, a lens system that creates the images, a light sensor, and an image processor that identifies discrete characteristics of each picture.
Although the science is interesting, the politics of Melafind’s approval are even more so. Its path through FDA is marred by stonewalling, decision reversal, and ultimately unnecessary and costly delay. In order to get approval, Mela Sciences, the company that created MelaFind, did a multi-year study comparing the accuracy of the device to a that of panel of dermatologists. This was what the FDA originally requested as necessary and sufficient for approval. The company proved that the device did as well as the dermatolgists and, indeed, on some dimensions of the study the device did better than the panel of dermatologists. However, the FDA bureaucrats deemed the device “not approvable,” saying that MelaFind “puts the health of the public at risk.”
Michael Mandel, a progressive economist, summarized the FDA’s position in his paper.
“FDA seems to be saying that it cannot approve MelaFind unless the device can:
• Outperform experienced dermatologists
• Perform well on any lesion that an inexperienced doctor might find suspicious
• Never miss any melanomas
• Turn an inexperienced doctor into the equivalent of a board-certified dermatologist.
This is a standard that no first-generation device can ever reach.”
At company’s request, FDA convened an advisory panel which recommended approval of Melafind in November 2010. However, the FDA commissioner declined the approval requesting more studies. Despite multiple requests from the company, FDA stonewalled and gave no standards that the company had to meet in order to get approval. At that point, a Citizen Petition was filed with the FDA, and an unrelated congressional hearing on FDA’s abuses and delays prominently featured the Melafind story. Under that pressure, FDA relented and approved Melafind in September 2011. However, it is only approved for use by board certified dermatologists.
Currently, the company is rolling out its device to high volume dermatologists in the Northeastern US based on its agreement with the FDA. (Mela Sciences website posting in early November) So, the rest of us just have to hold our breath and keep on biopsying all those suspicious lesions. Realistically, this device can be a great help even for non-dermatologists, especially where the physician resources are strained and patient access is limited.
So now, Melafind joins Reflectance Confocal Microscopy as a noninvasive technology for evaluation of pigmented lesions.