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news.Electro-Optical Sciences, a medical device company, has announced positive top-line results of its pivotal trial of MelaFind, a non-invasive, point-of-care instrument to assist in the early detection of melanoma, a form of skin cancer.
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The blinded study, conducted at seven centers across the US, included 1,831 pigmented skin lesions from 1,383 patients, making this the largest prospective study ever conducted in melanoma detection, said Electro-Optical Sciences (EOS).
According to EOS, MelaFind detected 112 of 114 (98% sensitivity; lower confidence bound of 95%) melanomas that were eligible and evaluable for primary sensitivity endpoint analysis, and 125 of 127 (98% sensitivity; lower confidence bound greater than 95%) melanomas overall. The protocol agreement calls for sensitivity endpoints of greater than 95% lower confidence bound.
MelaFind’s specificity, the ability to accurately rule out disease, was significantly superior (9.5%) to that of the study dermatologists (3.7%), who are skin cancer experts (p-value less than 0.02), the company said. The protocol agreement calls for MelaFind to be more specific than the study physicians at a p-value of less than 0.05.
EOS is working to complete its pre-market approval (PMA) application and expects to file it with the FDA shortly. The FDA has notified EOS that the MelaFind PMA will receive expedited review once the application is submitted.
Joseph Gulfo, president and CEO of EOS, said: “We are extremely pleased with the outcome of the pivotal study and are now focused on completing our PMA to submit to the FDA as quickly as possible. Our mission with MelaFind has always been to provide a useful tool to aid in detecting melanoma at its earliest, most curable stage. We look forward to discussing these data with the agency.”