Melanoma Detection Device Questioned

We’ve found an interesting piece in the New York Times Business daily about a device intended to aid diagnosis of melanoma, one of the fastest growing forms of cancer. Developed by Mela Sciences of Irvington, N.Y., the MelaFind system uses pattern-recognition algorithms to help a dermatologist who has picked out a suspicious pigmented spot to decide whether to perform a biopsy.

According to the article, the device “is polarizing the field of skin-cancer detection”, because it seems dermatologists are concerned that it’s a “gadget that may simply offer extraneous, and perhaps incorrect, data”.

Background

The dermatologist’s primary tool is their eyes, coupled with the dermatoscope, with which they can distinguish abnormal but benign lesions from potential melanoma in order to avoid unneeded biopsies. Of course, while new technology is welcomed, it comes with the attendant risk that unless it gives total accuracy it could be more harm than good if not used by qualified specialists. The FDA has itself recognised the risk of providing a false sense of security to inexperienced practitioners, especially because the reality is that MelaFind it is not even designed to pick up large melanomas, colorless melanomas or basal and squamous cell carcinoma that would be spotted by the dermatologist.

The FDA approved MelaFind for sale in the United States in late 2011, but the vote to approve it was not unanimous and the agency restricted the use of the device to dermatologists, following concerns that general physicians not trained as skin experts might miss these other forms of skin cancer. Furthermore the approval stated that doctors must successfully complete a MelaFind training program.

Physician comments

“My concern with MelaFind is that it just says everything is positive,” said a member of the FDA panel, he abstained on a vote about whether the device’s intended uses outweighed the risks.

In a company-financed study submitted to the FDA, the device missed two out of 127 evaluable melanomas, one FDA reviewer concluding; “There is inadequate data to determine any true value added for MelaFind for use by a dermatologist or other provider.”)

Full article is here.

Source: New York Times, Business Daily