MELA Sciences Predictive Probability Study Supports Increased Diagnostic Accuracy by Dermatologists for Melanoma
May 08 2014 - 8:37AM
Marketwired
MELA Sciences Predictive Probability Study Supports Increased
Diagnostic Accuracy by Dermatologists for Melanoma
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.
Study Overview 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.
Study Results 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.
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.
Media Diana Garcia Redruello MELA Sciences, Inc. 212-518-4226
Email Contact Investors David Collins, Eric Lentini Catalyst Global
212-924-9800 Email Contact
Strata Skin Sciences (NASDAQ:SSKN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Strata Skin Sciences (NASDAQ:SSKN)
Historical Stock Chart
From Apr 2023 to Apr 2024