MELA Sciences Issues Statement on FDA's New Draft Guidance on Pivotal Clinical Trials

MELA Sciences, Inc. MELA issued the following statement regarding the U.S. Food and Drug Administration's (FDA) draft guidance on Design Considerations for Pivotal Clinical Investigations for Medical Devices, including those conducted to support Premarket Approval applications. The draft guidance, which was issued August 15, discusses various recommended study designs, including randomized and blinded clinical studies. "We hold ourselves to the highest, most rigorous clinical standards, and consequently when we designed the pivotal study of MelaFind® with the FDA, we insisted on conducting a blinded study in which patients underwent both tests, investigators' eyes and MelaFind, which is more rigorous and scientifically preferred to randomization," said Joseph V. Gulfo, MD, President and CEO of MELA Sciences. "We also set effectiveness thresholds for melanoma detection beyond any standards ever reported in the clinical literature. We met those thresholds -- and ultimately enrolled more patients than had any other study previously conducted in melanoma detection. From what I understand about the new FDA draft guidance, the protocol we agreed to with FDA years ago meets or exceeds what the agency is now proposing. Additionally, we believe our approach is in harmony with the draft recommendations, for example, with respect to meeting with FDA and designing a pivotal trial to achieve a desired claim before starting the study. We are pleased that the latest draft guidance is consistent with the commitment MELA and FDA made seven years ago." MELA Sciences developed MelaFind® to serve as a tool to help dermatologists detect melanoma at its earliest, most curable stages. Clinical literature shows that approximately 25% or more of these early lesions are being missed with current detection techniques. In the largest clinical trial ever conducted in melanoma detection, MelaFind detected 98.3% of the melanomas, missing fewer than 2% of the early melanomas. Based on these positive data, the company submitted a PMA application for MelaFind to the FDA over two years ago, yet no final decision has been made.