Electro-Optical Sciences, Inc (EOS) 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 (PMA) application and expects to file it with the US Food and Drug Administration (FDA) shortly.
"MelaFind appears to be an excellent tool to help detect melanoma at the earliest, most treatable stage," said Gary D Monheit, associate clinical professor of Dermatology at the University of Alabama in Birmingham and the lead investigator for the MelaFind pivotal trial. "With no cure for late stage melanoma, early detection is our best defense against this cancer, which has reached epidemic proportions."
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.
"These clinically compelling data suggest that MelaFind may help detect melanoma earlier, and more accurately differentiate many of the non-malignant lesions that mimic melanoma," said Darrell Rigel, Clinical professor of Dermatology at New York University Medical School. "This should lead to improved biopsy efficiency and help reduce the number of unnecessary biopsies, which can be painful and scarring."
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.
In order to generate a comparison with dermatologists' ability to accurately detect melanoma, EOS conducted a parallel pilot readers' study with a different group of 39 dermatologists. 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.
"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," said Joseph V Gulfo, president and CEO of EOS. "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."
The company chose the final classification algorithm 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.
Melanoma is the deadliest form of skin cancer, responsible for approximately 80% of skin cancer fatalities.
EOS is a medical device company focused on designing and developing a non-invasive, point-of-care instrument to assist in the early detection of melanoma.