Electro-Optical Sciences, Inc. (EOS) has announced the positive top-line results of its pivotal trial of MelaFind. MelaFind is a non-invasive, point-of-care instrument to assist in the early detection of melanoma. 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. The company is working to complete its PMA application and expects to file it very soon with the US FDA. EOS and the FDA entered into a binding protocol agreement before the start of the study 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. The skin cancer experts who participated in this study had previously made the decision to biopsy all 1,831 pigmented skin lesions prior to enrolling the patients in the MelaFind clinical trial. The company has conducted a parallel pilot readers' study with a different group of 39 dermatologists in order to generate a comparison with dermatologists' ability to accurately detect melanoma. Using images and clinical histories of 23 randomly-selected melanomas from the pivotal study, this group of dermatologists, on average, would have decided to biopsy only approximately 18 (80%) of the melanomas, whereas the MelaFind result would have led to a biopsy of 22 of the melanomas (biopsy sensitivity of 96%). A larger readers' study to provide additional data regarding the sensitivity of MelaFind relative to physicians will commence shortly. Data from these studies will be submitted to the FDA. Final classification algorithm has been chosen by the company based on its success at identifying melanomas in a series of large, blinded and sequential internal classifier selection studies conducted immediately prior to the analysis of the pivotal trial data. Including the pivotal trial, the MelaFind classifier successfully detected 430 of the 432 melanomas against which it was tested. MelaFind uses 10 different wavelengths of light to see where a clinician cannot -- up to 2.5 millimeters below the skin's surface. Using advanced algorithms, trained and developed on a database of 9,000 pigmented skin lesions and over 600 melanomas, including those from the pivotal study, the system provides an immediate result that informs the decision to biopsy.