Questions frequently asked by dermatologists about MelaFind®, and the answers.
Q. Is MelaFind® a body scanner?
A. No. A scan means that MelaFind® would be used on all lesions on the patient’s body. MelaFind® should only be used on atypical pigmented skin lesions that you want additional information for a decision to biopsy.
Q. What is MelaFind®?
A. MelaFind®is the world’s first and only multi-spectral, non-invasive, painless, and 100% objective and automated computer vision technology that evaluates clinically atypical pigmented skin lesions and classifies them unambiguously and clearly based upon their level of 3-dimensional morphological disorganization. (Lesions that cannot be evaluated by MelaFind® are clearly designated as such to the operator)
Q. What will MelaFind® do for me?
A. MelaFind® is an additional tool for you in deciding whether or not to biopsy atypical pigmented skin lesions. MelaFind® can provide additional input as the “M” of the ABCDE’s to help inform biopsy decisions.
Q. How does MelaFind® work?
A. MelaFind® works by acquiring multi-spectral digital data from a clinically atypical PSL using 10 distinct wavelengths, invoking proprietary information processing algorithms for automatic analysis, and providing unambiguous output based on the level of 3-dimensional morphological disorganization of the lesion.
Q. How do I know MelaFind® will work?
A. The safety and effectiveness of MelaFind® was established in the largest prospective clinical study in melanoma detection ever conducted. Moreover, the FDA has reviewed and approved MelaFind® for use in melanoma detection. Additionally, MelaFind® has received CE Mark approval in the European Union.
Q. What does “High Disorganization” mean?
A. “High Disorganization” indicates a high level of 3-dimensional morphological disorganization (“MelaFind® Positive”). In the pivotal trial, a high level of 3-D disorganization was associated with a 98.3% sensitivity (95.1% at 95% lower confidence bound).
Q. What does “Low Disorganization” mean?
A. “Low Disorganization” indicates a low level of 3-dimensional morphological disorganization (“MelaFind® Negative”). In the pivotal trial, a low level of 3-D disorganization was associated with a 9.9% specificity, versus 3.7% for dermatologists (p < 0.05).
Q. Is MelaFind® covered by insurance?
A. Like all new and innovative technology, it is unlikely that health care plans will cover the MelaFind® procedure at this time. However, MelaFind® is affordably priced. An indigent patient program is provided to ensure access to this breakthrough technology.
Q. How will I fit MelaFind® into my practice?
A. As part of the MelaFind® placement package, we will provide practice management tips and insights on how best to optimize the integration of MelaFind® into your practice.