IRVINGTON, NY--(Marketwired - May 8, 2014) - MELA Sciences, Inc. (NASDAQ: MELA), developer of the MelaFind® system, an optical diagnostic device approved for use in the U.S. and the European Union to assist dermatologists in melanoma diagnosis, today announced statistically significant preliminary results of a study that measured the impact of predictive probability information (probability of lesion being melanoma and melanoma/high-grade) on dermatologists' decisions to biopsy ambiguous pigmented skin lesions.
At the January 2014 Winter Clinical Dermatology Conference, 191 dermatologists reviewed images of 12 lesions in a reader study facilitated by Darrell S. Rigel, MD, MS. Dr. Rigel is a Clinical Professor of Dermatology at New York University, Langone Medical Center. The physicians were asked if they would biopsy each lesion before and after seeing the MelaFind system probability information, and then both sets of data were analyzed.
The biopsy sensitivity of dermatologists increased from 68% to 89% with the addition of the MelaFind system probability information, and specificity increased from 39% to 54%. Sensitivity measures the percentage of lesions correctly identified as melanoma, and specificity measures the percentage of lesions correctly identified as not being melanoma. The average percentage of benign lesions selected for biopsy decreased from 61% to 46%. The p-value in all three measurements was statistically significant at p < 0.001. There was a non-significant change in the percentage of total lesions selected for biopsy.
Dr. Rigel, who facilitated the reader study, commented, "The preliminary results of this study are very compelling. The ability to improve diagnostic accuracy without increasing the rate of biopsies is very meaningful for physicians."
This data will be presented at the 2014 American Dermoscopy Meeting, June 17-19 in Bar Harbor, Maine.
About MELA Sciences, Inc. www.melasciences.com
MELA Sciences is a medical device company developing dermatology diagnostics utilizing state-of-the-art optical imaging. The Company's flagship product is the MelaFind® system, a non-invasive diagnostic tool to aid dermatologists in melanoma evaluation and diagnosis, which has secured FDA Pre-Market Approval (PMA) for the U.S. and CE Marking certification for the European Union. The MelaFind® system uses a variety of visible to near-infrared light waves to evaluate skin lesions from the surface to 2.5 mm beneath the skin. It provides images and data on the relative disorganization of a lesion's cell structure that provides substantial additional perspective to aid melanoma diagnosis. MELA is also exploring new potential uses for its core imaging technology and algorithms.
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