Melafind

MelaFind is a non-invasive fully automatic, computer-vision diagnostic system designed to provide additional information to dermatologists during skin examinations to detect cutaneous melanoma. Using light from visible to near-infrared wavelengths, MelaFind is able to evaluate skin lesions up to 2.5 mm beneath the skin, and by using automatic image analysis and statistical pattern recognition, MelaFind can provide information on a lesion’s level of morphologic disorganization. This additional objective information may be used by dermatologists to identify candidate lesions for biopsy to rule out melanoma. It provides a binary output: (1) High Disorganzation, the lesion should be considered for biopsy to rule out melanoma; and (2)Low Disorganization, the lesion should be considered for later evaluation.

Approvals:

  • MelaFind received CE Mark approval in September 2011 and is approved for use in the European Union.
  • MelaFind received approval by the US Food and Drug Administration in November 2011 for use in the US.

 

melafind

 

Data:

The largest study analyzing the specificity and sensitivity of MelaFind was done as a prospective multicenter trial from 2007 – 2008, accumulating1632 lesions (including 127 melanomas). The primary endpoints were the sensitivity and specificity of MelaFind, along with the specificity of clinicians, when evaluating pigmented lesions. The trial found a very high sensitivity of MelaFind to melanomas and high grade lesions (accurate detection of 172 out of 175 melanomas and other high grade lesions)1. However, MelaFind has been found to trade a high sensitivity for a low specificity (9.9%)1-2, in order to not miss any potential melanomas.

Industry Affiliations:

MelaFind is developed by a medical device company called MELA Sciences based in Horsham, PA.  http://melasciences.com

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