mela find

EOS designed MelaFind® to assist in the evaluation of pigmented skin lesions, including atypical moles, which have one or more clinical or historical characteristics of melanoma, before a final decision to biopsy has been rendered. MelaFind® acquires and displays multi-spectral (from blue to near infrared) digital images of pigmented skin lesions and uses automatic image analysis and statistical pattern recognition to help identify lesions to be considered for biopsy to rule out melanoma.

The key components of the MelaFind® system are listed below:

  • A hand-held imaging device comprised of several components:
  • an illuminator that shines light of 10 different specific wavelengths, including near infra-red bands;
  • a lens system composed of nine elements that creates images of the light reflected from the lesions;
  • a photon (light) sensor; and
  • an image processor employing proprietary algorithms to extract many discrete characteristics or features from the images.

Proprietary MelaFind® database of pigmented skin lesions. The database includes in vivo MelaFind® images and corresponding histological results of approximately 9,000 biopsied lesions from approximately 7,000 patients. EOS believes this is the largest such database in the US and a substantial barrier to competition.

MelaFind® lesion classifiers. The “brains” of the MelaFind® system, are sophisticated mathematical algorithms that distinguish melanoma from non-melanoma by comparing the lesions features with the characteristics of the benign and malignant lesions stored in EOS proprietary MelaFind® database.  

Lesion classifier development and training is an iterative process involving: (1) selection of the lesion features that provide for optimal lesion discrimination; (2) optimization of the mathematical formulas to differentiate benign lesions from melanoma; and (3) expansion of the size and diversity of our proprietary lesion database. The performance of the lesion classifiers is directly related to the size of the database used in classifier training, as well as the degree to which the training database is representative of the lesions that will be evaluated by MelaFind® in commercial use.

The MelaFind Premarket Approval (PMA) application is currently under review with the U.S. Food and Drug Administration (FDA). MelaFind will not be available commercially until the FDA has rendered an approval decision.

 
MelaFind

As with many diagnostic systems, the diagnostic performance of MelaFind® is characterized using two measures: (1) sensitivity — the ability to detect disease when it is present; and (2) specificity — the ability to exclude disease when it is not present. Since sensitivity and specificity are typically trade-offs, meaning that as one parameter increases the other decreases, the MelaFind® lesion classifier is developed and trained with the intention that MelaFind® will detect all melanomas in the training data set with the highest possible specificity.

MelaFind ® is currently under clinical investigation and is not yet available for commercial distribution in the United States or any other country. EOS has entered into a binding Protocol Agreement with the US Food and Drug Administration (FDA). EOS believes the Protocol Agreement, under which EOS and the agency agreed upon the specific parameters and conduct of the pivotal trial in order to establish the safety and effectiveness of MelaFind®, should help to enhance its ability to expedite the FDA approval process.
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