Despite Limitations, MelaFind May Be a Step Toward Earlier Diagnosis of Melanoma
Early last month the Food and Drug Administration approved the use of MelaFind, a computer-assisted melanoma diagnostic device from Mela Sciences, Inc (Irvington, NY). In this post we offer “the skinny” on MelaFind, noting it’s limitations.
For the last several decades, the incidence of malignant melanoma (MM) has been rising sharply both in the United States and worldwide. In the 1990’s the mortality rates seem to have stabilized due to earlier detection and treatment of thinner melanomas. For melanoma in situ, the 5 year survival rate is 100%. For metastatic melanoma, it is less than 20%.
MelaFind is the first FDA approved computer aided device for melanoma detection. Approved by a vote of 8-7 in favor with one abstention, MelaFind may be a step forward in a limited range of situations.
MelaFind is designed to assist in evaluating pigmented lesions that have one or more clinical or historical characteristics of melanoma. This means that a clinician first needs to identify a lesion as suspicious before MelaFind could be used.
Other limitations include the following:
+ MelaFind is indicated only for use on lesions that meet several specific criteria, including: accessibility by the MelaFind tool, sufficient size, sufficient diameter, no scarring or filbrosis, only lesions which are non-ulcerous and nonbleeding, and only in specified locations on a patient’s body.
+ Healthcare professionals must complete a MelaFind training program to use the device.
+ The cost of MelaFind scanning is not reimbursed by insurance companies.
The issue of false positives and false negatives
Larger questions also arise about the use of technology like MelaFind. For example, what about situations in which a clinician decides that a lesion is suspicious, but the MelaFind technology determines that it is not?
The FDA notes:
“Potential adverse effects for MelaFind are associated with incorrect test results or result interpretations. Failure of this device to perform as expected or a dermatologist’s failure to correctly interpret the results may lead to incorrect diagnoses and subsequently, improper patient management decisions in melanoma biopsy and treatment. False negative results may lead to delays in the timely diagnosis of melanoma and treatment, allowing an undetected condition to worsen that could possibly lead to death. False positive results could lead to patients unnecessarily undergoing more frequent screening and potentially invasive procedures such as a skin biopsy.”
In addition, other methods, including Melanoscan and confocal laser microscopy, have been shown to provide more sensitive and more specific assistance than MelaFind in many cases.
MelaFind may provide a measure of assistance in the early diagnosis of melanoma. The technology does have serious limitations, but may be helpful in situations that meet the specific criteria for which it is indicated.