Electro-Optical Sciences (MELA) Reports Top-Line Results from Pivotal Trial of MelaFind(R)
Electro-Optical Sciences, Inc. (NASDAQ: MELA) today 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, the deadliest form of skin cancer. 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. EOS is working to complete its Pre-Market Approval application and expects to file it with the US FDA shortly.
Prior to the start of the study, EOS and the FDA entered into a binding protocol agreement to stipulate the sensitivity and specificity endpoints that should be used to determine the safety and effectiveness of MelaFind.
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(footnote 1).
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 protocol agreement calls for MelaFind to be more specific than the study physicians at a p-value(footnote 2) of less than 0.05.
Almost half of the melanomas in the study were melanoma in situ, the most curable yet most difficult form of melanoma to detect.
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