Melanoma is a serious cancer, and one that isn’t always easy to spot. However, a new device called MelaFind uses imaging technology adapted from Defense Department target of interest identification programs to analyze irregular moles–and can even spot melanoma in its early stages. Currently available only in the northeast United States and Germany, the device is likely to change the way skin cancer is treated.
MelaFind, which was first made available to patients at the end of 2011, is a roughly five-foot-tall camera-computer-imaging system combo designed for deployment in medical offices and hospitals. In an in-person demonstration given to Co.Exist at the Manhattan offices of dermatologist Doris Day (yes, her real name), a camera-like handheld data acquisition unit based around a Zeiss lens system was positioned over a suspicious mole. A visible light was beamed over 10 varying wavelengths from a distance of approximately six inches; a series of proprietary algorithms then analyzed color, texture, and a host of other factors up to 2.5mm under the skin to search for irregular growth patterns. Within 60 seconds, the dermatologist (and patient) are alerted to whether or not the mole has a high level of irregular growth patterns. Dermatologists then have the option of biopsying or removing suspicious moles. MelaFind accurately detected melanoma at a 98% rate in clinical studies. The device also reduced the rate of unnecessary biopsies by 90%.
While MelaFind has an impressive melanoma detection rate, the device is not cheap to use. Each unit costs approximately $7,500; patients need to pay $50 and a dermatologist’s fee for a session. And MelaFind is not covered by insurance at this time. Joseph Gulfo of parent company MELA Sciences says that the device was currently deployed in only a few facilities along the northeast corridor and in Germany.
The algorithms at the core of MelaFind were adapted from Defense Department technology. MELA Sciences’ previous incarnation, Electro-Optical Sciences, originally worked on military projects. Electro-Optical ended up experimenting with the application of image analysis algorithms designed for spotting military targets of interest to health care. After pivoting from military software to health care technology, MelaFind was one of several projects the company worked on. Others included a system for detecting cavities without X-rays and a skin wrinkle measurement device.
Despite MelaFind’s revolutionary potential for melanoma detection, MELA Sciences fought a difficult seven-year battle with the Food and Drug Administration (FDA) from protocol agreement to pre-market approval. The agency, which has a troubled record in efficiently evaluating medical technology, previously denied approval to MELA. Following the denial, MELA filed a successful citizen’s petition to the FDA to overturn the denial, and the petition resulted in a highly unusual House of Representatives hearing, in which chief device regulator Jeffrey Shuren publicly acknowledged mishandling MelaFind’s application.
The adaptation of military technology to health care isn’t just a brilliant pivot; it’s also an indication of larger issues going on in the health industry. Algorithms are objective; light beams hitting a mole can analyze the growth patterns and arrangement of skin cells far more effectively than the naked eye. Although MelaFind might be a new technology, the use of machine imaging for diagnosis will become more and more frequent in the coming years.
Correction: An earlier version of this article misidentified MELA Sciences’ Dr. Joseph Gulfo.