IRVINGTON, NY--(Marketwire -02/23/12)- MelaFind, developed by MELA Sciences, Inc. (NASDAQ: MELA - News), was shown to improve melanoma detection in a study of 179 dermatologists. The average sensitivity of dermatologists before obtaining the MelaFind output was 69 percent, and the average sensitivity after obtaining the MelaFind output was 94 percent, according to a recent study published online in the Archives of Dermatology on February 20, 2012.
MelaFind, a non-invasive, multi-spectral computer vision system recently approved by the FDA, uses light from visible to near-infrared wavelengths to evaluate skin lesions up to 2.5 mm beneath the skin. The device analyzes the three-dimensional morphologic (i.e., structural) disorganization under the surface of the lesion and provides an unambiguous and easy to interpret output -- High Disorganization (Positive) or Low Disorganization (Negative) -- that a dermatologist can incorporate into the biopsy decision-making process.
At a continuing medical education conference, 179 practicing dermatologists were asked to evaluate a series of pigmented lesions selected from prior MelaFind studies. Biopsy decisions were recorded before and after the dermatologists received the MelaFind information.
"MelaFind was shown to increase dermatologist sensitivity from a baseline of 69 percent to a level of 94 percent, and it increased the percent of dermatologists that detected all of the melanomas in the series from 13 percent to 70 percent," said Darrell S. Rigel, MD, Clinical Professor of Dermatology at New York University Medical School and lead author of the study. "Consistent with other diagnostic tools, the information provided by this type of diagnostic device for pigmented lesions was integrated into all of the other factors used in making a biopsy decision but was not 'blindly' followed."
After obtaining the MelaFind information, participating dermatologists made more uniform biopsy decisions. In the study, specificity amongst participating dermatologists decreased overall as their sensitivity increased with MelaFind. However, on MelaFind negative lesions, the availability of the MelaFind information increased dermatologist specificity. According to the study, the MelaFind information resulted in a 17 percent reduction of biopsies of these histologically benign lesions.
"The study clearly demonstrated that MelaFind can provide significant clinical utility," added Dr. Rigel. Sensitivity, the ability to detect disease when disease is truly present in a population, and specificity, the ability to correctly rule-out disease when disease is truly absent, are the measures used to assess diagnostic performance.
MELA Sciences is executing a controlled and deliberate launch of MelaFind predominantly in the Northeastern U.S. and in several key cities throughout Germany. During this period, the company will work with the dermatology practices to train and assist them in using MelaFind appropriately and to incorporate its use successfully into their practices. This approach is appropriate for a first-of-a-kind breakthrough product and will serve as the basis for more widespread dissemination of MelaFind in the future.
For more information and additional study information, visit http://archderm.ama-assn.org/cgi/content/full/archdermatol.2011.3388?etoc. The study results will be published in a subsequent print issue in 2012.
About MELA Sciences, Inc.
MELA Sciences is a medical device company focused on the design, development and commercialization of non-invasive tools to provide additional information to dermatologists during melanoma skin examinations. The Company's flagship product, MelaFind®, is intended to be used when a trained dermatologist chooses to obtain additional information to help decide whether to biopsy certain indeterminate pigmented skin lesions. MelaFind has received approval from the U.S. Food and Drug Administration and is approved for use in the U.S. In addition, MelaFind has received the CE Mark and is approved for use in the European Union.
For more information on MELA Sciences, visit www.melasciences.com.
This press release includes "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to our plans, objectives, expectations and intentions and other statements that contain words such as "expects," "contemplates," "anticipates," "plans," "intends," "believes," "assumes," "predicts" and variations of such words or similar expressions that predict or indicate future events or trends, or that do not relate to historical matters. These statements are based on our current beliefs or expectations and are inherently subject to significant known and unknown uncertainties and changes in circumstances, many of which are beyond our control. There can be no assurance that our beliefs or expectations will be achieved. Actual results may differ materially from our beliefs or expectations due to financial, economic, business, competitive, market, regulatory and political factors or conditions affecting the company and the medical device industry in general, as well as more specific risks and uncertainties facing the company such as those set forth in its reports on Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission (the "SEC"). Factors that might cause such a difference include whether Melafind® achieves market acceptance or becomes commercially viable. Given the uncertainties affecting companies in the medical device industry such as the Company, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. The Company urges you to carefully review and consider the disclosures found in its filings with the SEC which are available at www.sec.gov and www.melasciences.com.
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