If dermatologists had a reliable tool to identify potential melanoma skin cancer tumors prior to biopsy, patients would benefit in two ways. First, they would be less likely to have a dangerous lesion go untreated. Second, they could benefit from a reduction in unnecessary biopsy procedures for benign moles. The makers of the MelaFind imaging device are hoping that their handheld diagnostic tool will overcome FDA hurdles and make this a reality. The company faced a major setback in November when its device was harshly critiqued by a pre-approval review board.
The board members did not find the data presented by MELA Sciences to be compelling. Specifically, they were concerned that the imaging tool did not represent a real improvement over current visual assessments done by dermatologists. They were also hesitant to support approval because testing showed it was possible for the device to miss melanoma skin cancer in rare cases. The final ruling from the FDA isn’t yet in. If the FDA denies the company’s request for approval, further testing and potential improvements to the product’s performance may be required before the device can be marketed in the U.S.
MelaFind Developers Believe Device Offers Greater Consistency
The MelaFind computerized dermoscope analyzes a range of light wave spectrums as they are absorbed by or refracted by the tissues in a suspected skin lesion. Then, it provides a “yes” or “no” response to the question of whether a biopsy is recommended. In the clinical trial conducted prior to seeking FDA approval, the MelaFind device correctly identified 98% of melanoma tumors. The catch is that the testing for the study only included lesions that had been recommended for biopsy by each patient’s individual dermatologist. So, the melanoma skin cancer had already been “caught” or identified using the typical visual approach.
However, 39 dermatologists were given patient overviews and pre-biopsy images of each suspicious mole in the study without being told the result of the subsequent biopsy. They were then asked to state whether they would recommend a biopsy. The results varied widely. Each dermatologist selected a different set of the early melanomas presented as ones they would have biopsied. Only 1 out of 5 melanomas were identified by all the dermatologists.
This indicates that patients may or may not have an early melanoma caught depending on the subjective criteria their dermatologist uses to identify suspicious lesions. The goal of the MelaFind technology is to provide a more consistent, objective basis for recommending biopsy. So far, it appears that the evidence threshold may not be high enough for FDA approval. Of course, patients can still go the old fashioned route of getting a second opinion to increase the chances of an accurate diagnosis of early stage melanoma.