IRVINGTON, N.Y., July 24, 2014 (GLOBE NEWSWIRE) -- 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 new study results demonstrating the effectiveness of MelaFind predictive probability information when used by dermatology residents. The results strongly correlate with the findings of a similar, previously reported analysis on dermatologists’ decisions to biopsy. Together, these studies suggest the clinical impact of MelaFind predictive probability information (probability of lesion being melanoma and melanoma/high-grade) on decisions to biopsy suspicious pigmented skin lesions may expand to a wider range of practitioners.
The studies were facilitated by Darrell S. Rigel, MD, MS, a Clinical Professor of Dermatology at New York University, Langone Medical Center. Dr. Rigel commented, “Each study was conducted independently with dermatologists and residents, using the same methodology. The results show that the MelaFind information had a similar impact of increased diagnostic accuracy with no significant change in biopsy rates for both dermatologists and residents. It is very compelling to see similar improvement rates in both groups.”
Study Methodology
The data for each study group were collected independently at separate dermatology conferences using equivalent methodology. Participants were presented with high-resolution clinical close up, clinical overview, and dermoscopic images for 12 lesions (3 melanomas in situ, 2 thin invasive melanomas, 7 atypical non-melanomas). The participants were asked if they would biopsy the lesion utilizing the presented images. After the results were collected, the MelaFind probability information was shown and the participants were asked again whether they would biopsy the lesion. Both sets of data were analyzed.
Resident Dermatologist Study Results
Data from 122 resident dermatologists were analyzed. Biopsy sensitivity increased by 29%, 54% to 83%, and the percentage of benign lesions selected for biopsy decreased by 17%, 50% to 33%. The percentage of resident dermatologists electing to biopsy all 5 melanomas increased by 46%, 3% to 49%, and overall diagnostic accuracy increased by 22%, 52% to 74%. The p-value in all four measurements was statistically significant at p<0.001. Results occurred with a non- significant change in the total number of lesions selected for biopsy.
These new findings correlate with the previously reported study results that showed dermatologists’ overall diagnostic accuracy improved 18%. Similar to the residents, the dermatologist improvement occurred with a non-significant change in total number of lesions selected for biopsy.
The resident dermatologist study results will be presented at the Practical Dermatology & Dermatopathology Symposium August 14-17 in Vail, Colorado.
About MelaFind www.melafind.com
MelaFind is the first and only medical device with FDA Pre-Market Approval (PMA) for the U.S. and CE Marking certification for the European Union designed to assist dermatologists in the evaluation and diagnosis of melanoma at its most curable stage. The MelaFind® system utilizes innovative software driven technology and state-of-the-art 3-D optical imaging to non-invasively extract data 2.5 mm below the skin surface from patient’s pigmented ambiguous moles and objectively analyzes them with proprietary algorithms. MelaFind provides important additional perspective to physicians via 3-D spectral images and 100% objective data analysis to help them better understand the structural disorganization of a patient’s pigmented ambiguous moles (before cutting the skin) during the evaluation and diagnosis process for melanoma.
About MELA Sciences, Inc. www.melasciences.com
MELA Sciences is a medical technology company dedicated to designing and developing innovative software-driven technology for the clinical early detection and prevention of skin cancer. MELA Sciences conducted the largest, positive prospective study ever done on the melanoma disease, and is the first and only medical technology company to receive both FDA Pre-Market Approval (PMA) for the U.S. and CE Marking certification for the European Union for a device of this nature.
Safe Harbor
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 may contain words such as “seeks,” “look forward,” and “there seems” that suggest future events or trends. These statements are based on our current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from our 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 set forth in the company’s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all of these forward-looking statements may prove to be incorrect or unreliable. MELA Sciences assumes no duty to update its forward-looking statements and urges investors to carefully review its SEC disclosures available at www.sec.gov and www.melasciences.com .
CONTACT: Media Diana Garcia Redruello MELA Sciences, Inc. 212-518-4226 dgarcia@melasciences.com Investors Andrew McDonald LifeSci Advisors, LLC 646-597-6987 Andrew@LifeSciAdvisors.com
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