An Intro to MelaFind; FDA Gives it the Thumbs-Up Approval
In November, the FDA approved the use of MelaFind, a computer-assisted melanoma diagnostic device from Mela Sciences, Inc (Irvington, NY). In this introductory post, we will provide some background to MelaFind.
A number of different technologies have been developed in recent years to assist dermatologists in the earlier diagnosis of melanoma. MelaFind is the first FDA approved computer aided device for melanoma detection.
The development team describes MelaFind as a “novel multispectral digital dermoscope with ‘expert system’ software that performs the image processing sequence automatically end-to-end, leading to differentiation between early melanoma and benign atypical neoplasms.”
The MelaFind digital dermoscope captures both visible and infrared image data. Image acquisition is done under computer control to ensure standardization. The digital dermoscope uses the image data to uncover new features that can only be obtained with computer assistance, and uses the potent mathematical framework of statistical pattern recognition to arrive at a differential diagnosis.
In February, the Archives of Dermatology published a prospective, multicenter, blind study on the diagnostic performance of MelaFind vs dermatologists, which was evaluated using the histologic reference standard.
In the trial, MelaFind achieved a high sensitivity to thin melanomas and borderline lesions of >98%. The average specificity was 9.5% Both of these parameters were better than the clinical diagnoses made by the investigators.
Ultimately, the decision whether the lesion is suspicious and requires a biopsy rests with the dermatologist. It is thisdecision that would lead a dermatologist to use the MelaFind to scan a lesion. As we know, it is incredibly helpful when the computer confirms a diagnosis of melanoma after the clinician considers a lesion either melanoma or suspicious for melanoma.