MELA Sciences MELA today announced that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter for the MelaFind(R) Pre-Market Approval (PMA) application. The company intends to work with the agency to finalize the physician and patient labeling, package insert, user’s guide, training program and clinical protocol for a post-approval study in order to obtain final approval.
“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,” said Joseph V. Gulfo, MD, President and CEO, MELA Sciences. “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.”
The Approvable Letter from the FDA follows the CE Mark for MelaFind issued earlier this month.
“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,” said Darrell S. Rigel, MD, Clinical Professor of Dermatology at New York University Medical School. “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.”
“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,” said Laura K. Ferris, MD, PhD, Assistant Professor of Dermatology and Director of the University of Pittsburgh Department of Dermatology Clinical Trials Unit.
The studies used to support the PMA application for MelaFind were the 1,383 patient U.S. pivotal trial and the companion reader study of 110 dermatologists: the device demonstrated a 98% sensitivity in the pivotal trial, whereas dermatologists had a 72% sensitivity in the adjunctive reader study.