FDA-approved computer vision system that offers 100% objective information based on
Detecting melanoma with the
the structure of atypical
pigmented skin lesions
human eye can be challenging
The many faces of melanoma are difficult to recognize. While trained dermatologists have no difficulty recognizing advanced melanoma, melanomas at their most curable stages (melanoma in situ and invasive melanomas
< 1 mm in Breslow thickness) may mimic histologically benign look-alikes. Many patients present with PSLs that have one or more characteristics of melanoma posing the difficult clinical challenge of deciding what to biopsy. MelaFind® is designed to help.
MelaFind was designed by dermatologists and is ONLY for dermatologists. MelaFind® evaluates multi-spectral data captured from up to 2.5 mm into the skin providing dermatologists, for the first time, with objective information about the 3-dimensional morphological disorganization of the lesion. MelaFind® is CE Mark approved, and it is the first FDA-approved device of its kind with a high sensitivity in detecting melanoma at its most curable stage. MelaFind®:
- Non-invasively captures, displays and stores multi-spectral lesion information 2.5 mm into the skin at the point-of-care
- Uses sophisticated algorithms that objectively analyze the lesion
- Demonstrates very high sensitivity to the most treatable and curable melanomas (as well as high grade dysplastic nevi) based on the evaluation of complex cellular patterns of lesion disorganization
- Has been developed, trained, and tested on the largest proprietary database of PSLs, with over 10,000 in vivo lesions and corresponding histological results in over 7,000 patients including over 600 melanomas, most of which were highly curable (melanoma in situ and invasive melanoma with < 1 mm Breslow thickness)
- Is designed to automatically exclude poor quality data as a safety measure
- Sees at a 3 melanocyte-resolution (20 microns)
Innovative computer vision technique
+ 100% Objective Analysis
MelaFind® acquires multi-spectral data from clinically atypical pigmented skin lesions (PSLs) and then analyzes the information using sophisticated proprietary computer algorithm software. This new information requires no interpretation, but rather, incorporation of the MelaFind® data, which allows for a more informed biopsy decision.Fast and objective information
With the click of a button, MelaFind® acquires digital data using 10 distinct wavelengths. Each wavelength allows it to see deeper and deeper (down to 2.5 mm) into a clinically atypical PSL. Sophisticated and proprietary computer algorithms then quickly analyze this data. Immediate output is provided in few steps:
- Selection: Dermatologist identifies clinically atypical PSL of interest
- Prepare: Hair is removed and isopropyl alcohol applied to the lesion to optimize data acquisition
- Acquire: With the click of a button, MelaFind® acquires digital data derived from 10 distinct wavelengths (from blue to infrared) down to 2.5 mm
- Output: In under a minute, MelaFind® provides information about the level of 3-dimensional morphological disorganization of the lesion as “High Disorganization” or “Low Disorganization”. Multiple images of the lesion from each wavelength will also be displayed on the screen.
Features & Benefits
MelaFind® objectively analyzes atypical
PSLs right in the exam room
MelaFind® is a non-invasive, painless and 100% objective and automated computer-vision system that captures multi-spectral digital data from clinically atypical pigmented skin lesions and classifies them based upon level of 3-dimensional morphological disorganization: High Disorganization or Low Disorganization.
Four primary components: an illuminator, a lens system, a photon sensor and a liquid crystal display
The lens system
Creates images of light scattered back from lesions
Liquid Crystal Display
Shows enlarged images of lesions
Extracts distinct lesion characteristics via proprietary computer algorithms
Fast and objective
MelaFind® acquires multi-spectral data from up to 2.5mm under the skin’s surface in seconds and provides objective output in under a minute
Shines visible light of 10 varying wavelengths from blue (430 nm) to near infrared (950 nm) for data capture
The photon sensor
Converts scattered light particles into electrons for analysis
Multi-spectral data 2.5 mm beneath the skin surface
MelaFind® acquires multi-spectral digital data under the skin’s surface containing features not visible to the naked eye
Classifies lesion at the core according to “High” or “Low” disorganization via proprietary computer algorithms
MelaFind® is ergonomically designed and portable
|State-of-the-art optics using advanced technology|
|Multi-spectral data||Captured and displayed for every lesion from up to 2.5 mm in depth|
|Dermoscopic image||Color visual created from the multi-spectral data|
|9-element lens system||Made by Carl Zeiss, known worldwide for premium optics|
|Liquid crystal display||Multi-spectral and dermoscopic images of lesions along with MelaFind® output are clearly displayed and easy to view via this touch screen|
|External Clinical Camera||Takes high-resolution images|
|Additional system components|
|Full QWERTY computer keyboard for note taking|
|High-speed computer that is HIPAA compliant (country specific)|
|Removable electronic data card allows for mobile data storage of individual patient records|
|Mobile, unobtrusive, ergonomically designed cart moves easily within exam rooms and through-out the office|
|Card reader for electronically uploading patient data for storage and printing patient records|
|Detailed reports of MelaFind® evaluation summary with multi-spectral images for patient, physician and pathologist|
The first CE Mark and FDA approved system
MelaFind® has been clinically proven to correctly
identify melanoma at a very high rate of detection1
- 98.3% sensitivity to melanoma and high-grade lesions
- Studies show dermatologists detect 70-80% of melanomas
- —Correctly identified 172 out of 175 melanomas and high-grade lesions in the largest prospective study ever performed in melanoma detection
- —Median Breslow thickness of invasive melanomas was 0.365 mm and 45% of all melanomas were in situ indicating melanomas tested were clinically challenging
- Studies reported in the medical literature show dermatologists on average detect
70—80% of the most curable and readily treatable melanomas
- Designed for dermatologists to use in their efforts to detect melanoma at the most curable stage
- 10.8% MelaFind® specificity vs. 5.6% dermatologist specificity*
- MelaFind® correctly called more normal moles “Low Disorganization” than dermatologists, which could mean fewer biopsies of moles that were histologically benign.
In the Pivotal Trial, the biopsy ratio of MelaFind® is 7.6:1 compared to 8.6:1 for dermatologists2. Biopsy ratios for dermatologists were as high as 50:1 in the literature3-8.
*Pooled results shown. Average specificity results: MelaFind® 9.9% vs. dermatologist 3.7% specificity
Pivotal Study Design: MELA Sciences conducted the largest prospective study ever conducted in melanoma detection with 1383 patients presenting with 1831 pigmented skin lesions. The study was multi-center and blinded. Of the 1831 lesions enrolled, 1632 were considered eligible for analysis including 127 melanomas and 48 high grade lesions. The aim of this study was to establish the safety and effectiveness of MelaFind® using sensitivity and specificity as metrics. MelaFind® successfully met both prescribed endpoints.
- Developed, trained, and tested using the largest historical database of more than 10,000 biopsied PSLs, including 600 melanomas of which 45% were in situ
In clinical trials, there were no reported adverse events related to the use of MelaFind®. However, the isopropyl alcohol used when preparing a lesion for data capture with MelaFind® may cause minor skin irritation in some patients.
While MelaFind® is intended for use when a dermatologist chooses to obtain additional information for a decision to biopsy, MelaFind® should NOT be used to confirm a clinical diagnosis of melanoma. As with all tools that provide additional information during skin exams, there is a risk that melanomas will be missed and histologically benignmoles will be biopsied.
MelaFind® — Medical Publications
Published Articles about MelaFind® in Medical Journals
- Elbaum, M. "Automated Diagnosis: Illustrated by the MelaFind® System", in Atlas of Dermoscopy, Ashfaq A. Marghoob, M.D., Alfred W. Kopf, M.D., and Ralph Braun, M.D., editors, Parthenon Publishing, CRC Press, New York and London, pp. 325-341, 2004.
- Elbaum, M. "Computer-Aided Melanoma Diagnosis." Dermatologic Clinics, Vol. 20, pp. 735-47, November 2002.
- Elbaum M, Kopf AW, Rabinovitz HS, Langley RGB, Kamino H, Mihm MC, et al.
- "Automatic differentiation of melanoma from melanocytic nevi with multispectral digital dermoscopy: A feasibility study." Journal of the American Academy of Dermatology, Vol. 44, pp. 207-218, February 2001.
- Friedman et al. The Diagnostic Performance of Expert Dermoscopists vs. a Computer-Vision System on Small-Diameter Melanomas, Arch Dermatol 2008; 144(4); 476-482.
- Gutkowicz-Krusin D, Elbaum M, Jacobs A, Keem S, Kopf AW, Kamino S, et al. "Precision of automatic measurements of pigmented skin lesion parameters with a MelaFind® multi-spectral digital dermoscope." Melanoma Research, Vol. 10, pp. 563-570, December 2000.
- Gutkowicz-Krusin D, Elbaum M, Szwaykowski P, Kopf AW. "Can early malignant melanoma be differentiated from atypical melanocytic nevus by in vivo techniques? Part II. Automatic machine vision classification."
- Skin Research and Technology, Vol. 3, pp. 15-22, January 1997.
- Mayer, J. “Systematic review of the diagnostic accuracy of dermatoscopy in detecting malignant melanoma.” Medical Journal of Australia, Vol. 167, pp. 206-210, May 1997.
- Monheit G, Cognetta AB, Ferris L, Rabinovitz H, Gross K, Martini M. et al. “The performance of MelaFind®.” [published online ahead of print October 18 2010]. Archives of Dermatology. 2010. http://archderm.ama-assn.org/.
- Rigel D, Roy M, Yoo J, Cockerell CJ, Robinson J, White R. “Impact of Guidance From a Computer-Aided Multispectral Digital Skin Lesion Analysis Device on Decision to Biopsy Lesions Clinically Suggestive of Melanoma.” [Published online February 20, 2012]. Archives of Dermatology 2012.