Irvington-NY based Electro-Optical Sciences (EOS), developer of The MelaFind System, a handheld imaging device that detects melanomas at an early stage, announced last week that its pivotal trial is over two-thirds complete. Six study sites are currently active, with an additional seventh and final site expected to come online in the coming weeks.
MelaFind is a non-invasive, point-of-care instrument that emits various wavelengths of light up to 2.5mm deep into the skin in order to capture images of suspicious pigmented skin lesions. This data is then analyzed against a database of melanomas and benign lesions. As early-stage melanomas often appear benign, the “Lesion Classifier” recommends whether a lesion should be biopsied.
Currently, a physician’s biopsy decision is governed by the presence of asymmetry, border irregularity, color variation, and size (a diameter greater than 6 mm). A doctor’s subjective evaluation often leads to two outcomes – melanomas being missed at the early, curable stages or a needless biopsy.
In a previous blinded trial examining 352 suspicious pigmented skin lesions, MelaFind had 100% sensitivity in finding a melanoma and achieved 48.4% specificity (compared with the study dermatologists’ sensitivity of 96.4% and specificity of 28.4%). Specificity, in this case, is the probability that an individual who does not have melanoma will be correctly identified as negative; high specificity reduces the need for biopsies.
Based on EOS market research, physicians will seek the MelaFind’s guidance. In a survey of 18 dermatologists and 12 primary care doctors, 60% of both groups indicated that they will be likely early adopters of MelaFind technology. The dermatologists indicated that on average per month they performed skin checks for melanoma 325 times. During such skin checks, a pigmented skin lesion of concern was identified 230 times; of these, physicians biopsied 81 suspicious skin lesions.
The current study will support the company’s Pre-Market Approval application. EOS has a Protocol Agreement with FDA, under which the study is being conducted. In addition, it has received Expedited Review Designation from FDA for the MelaFind PMA.
In May, 2007 the company anticipated commercialization of MelaFind in mid-2008. That figure was based on PMA approval sometime by the end of 2007.
Skin cancer is the most common form of cancer in the U.S., with over one million cases diagnosed each year. It also is one of the fastest growing cancers in the U.S. and the leading cause of cancer death in women ages 25-30. Melanoma accounts for only 4% of skin cancer cases, but is responsible for 75% of skin cancer deaths.
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