A medical device for detecting skin cancer melanoma – MelaFind – has been given an Approvable Letter by the FDA (Food and Drug Administration) in response to its PMA (Pre-Market Approval) application. Mela Sciences says it is liaising with the FDA to finalize patient and physician labeling, as well as providing a user’s guide, and training program.
MelaFind is a tool for the evaluation of clinically atypical cutaneous pigmeted lesions when a dermatologist chooses to gather additional data before making a final decision to biopsy to rule out melanoma. Mela Sciences says that MelaFind is a “non-invasive and objective multi-spectral computer system designed as a tool to aid dermatologists in the detection of early, (e.g. non-ulcerated, not bleeding, or less than 2.2cm in diameter) melanoma.”
It is not a screening device and is not indicated for non-pigmented lesions, lesions that are clinically confirmed as melanomas, or lesions on special anatomical sites, such as acral, mucosal, or subungual. The hand-hel imager is used to capture lesion images.
Joseph V. Gulfo, MD, President and CEO, MELA Sciences, said:
“The FDA’s Approvable Letter for MelaFind represents a monumental milestone for MELA Sciences and the millions of Americans who are at risk of developing melanoma, the deadliest form of skin cancer. The company has worked tirelessly to develop an objective tool to help dermatologists detect melanoma at its earliest, most curable stages.
Although melanoma is virtually 100% curable if detected at its earliest stage, one American dies from the disease every hour. We firmly believe that MelaFind has the potential to lower those tragic numbers. We are extremely pleased with the FDA’s decision and will work diligently to answer all open questions and finalize the post-market study protocol in the coming weeks.”
MelaFind has recently received the CE Mark, which allows it to be marketed throughout the European Union.
Darrell S. Rigel, MD, Clinical Professor of Dermatology at New York University Medical School, said:
“MelaFind has the potential to provide dermatologists with significantly more information about indeterminate pigmented skin lesions to help us when deciding on which lesions to biopsy to detect melanoma as early as possible. While there have been incremental improvements in imaging tools for melanoma detection, we still primarily rely on our judgment based on a visual examination to select the lesions to biopsy; data show that this is often not enough.”
Laura K. Ferris, MD, PhD, Assistant Professor of Dermatology and Director of the University of Pittsburgh Department of Dermatology Clinical Trials Unit, said:
“Taken together, the multiple clinical trials demonstrate that MelaFind represents a significant advance and should have a positive impact on patient outcomes once it’s approved and available to dermatologists.”
The FDA examined a pivotal trial involving 1,383 patients in the USA, as well as the companion reader study of 110 dermatologists. MelaFind was found to be 98% accurate in the trial, while dermatologists had a 72% sensitivity.
Melanoma is responsible for about three-quarters of skin cancer fatalities. In this year alone, there will be 70,230 new cases of invasive melanoma and approximately 8,790 melanoma-related deaths, according to the American Cancer Society.
Between 1980 and 2004 the annual melanoma rate among young white women in the USA rose 50%.
Less than 15% of those with stage IV melanoma survive for five or more years – the majority die within six to ten months. Effective melanoma treatment depends greatly on early diagnosis. When the melanoma is limited to the epidermis (outer layer of skin), the cure rate by surgically removing it is virtually 100%.
Written by Christian Nordqvist