MELA Sciences has reported that the company's pre-market approval (PMA) application for MelaFind will be reviewed by the General and Plastic Surgery Devices Panel appointed by the FDA on August 26, 2010.
MELA also reported the results of an internet-based US reader study performed by 155 physicians, including 110 dermatologists, on images and clinical information derived from 130 lesions (melanomas and non-melanomas) enrolled in the MelaFind pivotal trial.
According to the study, the average sensitivity of dermatologists was 72%. The sensitivity of MelaFind was 96.9%, which was superior to dermatologists at p-value of less than 0.0001. The company plans to submit the results of the reader study to a peer review journal for publication.
MELA said that the panel will review the MelaFind PMA application, which the company submitted to the agency in June 2009. It is based on the positive results of the company’s landmark pivotal study, which included 1,831 pigmented skin lesions from 1,383 patients, making this the largest prospective study ever conducted in melanoma detection.
Prior to the start of the study, MELA and the FDA have entered into a binding protocol agreement to stipulate the study design, including the sensitivity and specificity endpoints that should be used to determine the safety and effectiveness of MelaFind. The company believes that the results of the pivotal study met and exceeded the pre-defined endpoints.
Joseph Gulfo, president and CEO, said: “We and our advisors look forward to the Panel meeting with great anticipation. We have had positive and constructive interactions with the agency culminating in the submission of our formal response to the FDA’s questions regarding the PMA application earlier this month.
“We are fully focused on preparing for the August 26th panel meeting and firmly believe that MelaFind will be found to be a valuable tool to help dermatologists detect melanoma at the earliest, most curable stage.”