PracticalDermatology

Early detection of melanoma is critical for securing appropriate treatment. While a number of potential therapies are currently under investigation to treat melanoma at varying stages, several advancements in technology offer clinicians significant new ways of approaching melanoma in both the detection and biopsy phases. Of these technologies, the device that has perhaps gained the most prominence is MelaFind (MELA Sciences). Since its FDA clearance in 2011, MelaFind has been the source of robust discussion and debate. During that time it has shown to be an extremely valuable device, if used and approached appropriately. Ahead, I will discuss the utility of MelaFind from the perspective of my experience using the device in my own practice.

The Science of Melanoma Detection Technology

MelaFind is meant to complement a skilled physician’s process for detection of early melanoma. Instead of performing painful biopsies on areas that contain abnormal pigmentation, MelaFind allows for the requisition of actual quantitative data concerning a lesion. It gains feedback via light inputs, which are then processed by an algorithm. This provides clinicians with an enlarged detailed image of the area in conjunction with various quantitative data concerning cellular disorganization. Ultrasensitive lenses and sensors are used to detect light scatter, and within seconds a 3D anatomical map of the lesion is calculated. MelaFind can penetrate up to 2.5mm into the skin surface, making it capable of being used virtually anywhere on the skin while providing extremely accurate data that helps to distinguish between melanoma and other types of skin lesions.

MelaFind is painless for the patient and requires virtually no pre-procedure preparation. Alcohol is applied to the targeted areas, and the MelaFind handheld applicator is used directly on the skin. MelaFind works by pulsing a series of 10 different wavelengths of light, precisely measuring the spectral output of the lesion, providing completely objective data about the physical makeup of the lesion. Importantly, MelaFind is not a diagnostic tool, but is rather used for its ability to deliver valuable additional information for a more informed decision concerning possible melanoma developments.

Perception and Approach

As with any new technology, several assumptions and preconceptions have taken hold in the medical community about MelaFind. Therefore, before discussing how I use this machine in practice, it may be helpful to address some of these views. For example, there seems to be a perception that MelaFind, by its design, displaces the diagnostic capacities of the dermatologist. This, however, is misrepresentative of MelaFind’s capabilities. It bears reiterating that MelaFind is not a diagnostic device. Rather, it is an aid that can be used in particular situations that can help dermatologists decide when to biopsy and when not to biopsy. Thus, MelaFind is similar to dermoscopy, in that it is a tool that helps you be more accurate. It’s not designed to be used for the most obvious lesions or benign growths. In fact, a study comparing the use of MelaFind among family practitioners and dermatologists showed that dermatologists were still better at diagnosing melanomas than family doctors.¹ These findings underscore the reality that MelaFind is an aid; a tool in the diagnosis of melanoma, not a means of diagnosis.

MelaFind is most useful in situations wherein the clinician is unsure about a particular lesion. Results from a MelaFind scan will lend greater assurance to the decision of whether to biopsy the lesion or keep a watch for future visits. It is also useful when you have a patient with a large number of moles. In this situation, there are some moles that you will look at and know that you need to biopsy, as well as some moles that are obviously benign. But for moles that are somewhere in between, you can use dermoscopy as well as MelaFind, both of which will aid in the decision-making process.

When it comes to the utility of MelaFind, perception and approach make all the difference. It is not only unfair to hold MelaFind to an absolute diagnostic standard, but it is also a misunderstanding of the device and its function. Another faulty understanding of MelaFind is to compare it to clinical photography. Photography allows clinicians to follow a lesion over time, not only to see if it’s changed, but also to see if there is anything new. By contrast, MelaFind provides important information about a lesion at the moment. In the end, the clinician is still making the call to biopsy a mole or not, but the MelaFind device provides an in-the-moment analysis that can determine the relative likelihood that a lesion is malignant.

MelaFind in Practice

When it comes to how MelaFind is incorporated into practice, there are many different avenues one can take. I have two devices in practice, and I perform the procedure myself. When a patient is in for a full skin check, I will biopsy the moles I am worried about. For any moles that are ambiguous, we will schedule the patient for a specific MelaFind appointment.

During these MelaFind appointments, after the patient is undressed, I examine the patient along with my nurse and we select up to five lesions to scan with MelaFind. Originally the MelaFind card would only allow up to five scans in a visit. Now it allows more, but as a matter of comfort, I will only scan up to five lesions. The reason for this is that if a larger number of moles all come back as high-risk for malignancy, we would have to perform many biopsies in one visit. The general rule with deciding which moles to scan: if I scan it, I’m not worried about it enough to biopsy the mole without the MelaFind scan. If the scan results come back high, I will then biopsy the lesion. If the risk is low, we can keep a watch on that particular mole and perhaps scan it again on a future visit. If, on the other hand, I am worried about a specific mole and the MelaFind says the malignancy risk is low, I would still biopsy the lesion.

In my practice, I tend to use MelaFind only when I am less certain about a particular mole. To use the device too much is essentially undermining its function. MelaFind helps us to be more accurate, but it also serves the dual function of preventing unnecessary biopsies. It is designed such that it will provide more false positives than false negatives, so in instances where you do not need a MelaFind to be worried, the better option is always to biopsy.

Another Piece of Evidence

MelaFind has a great deal of utility in dermatology practices, however the perception of that utility can be a matter of context. Diagnosing skin cancer is a nuanced process, and a device such as MelaFind aids in clarifying some of the gray areas, by providing real-time data that may lend greater assurance to the decision to biopsy or not. How one approaches and thus applies this device is key, however. Neither MelaFind nor any device can replace clinical skills. Rather, MelaFind is designed to function in conjunction with clinical skills. The data it provides function as more evidence that clinicians can use in aiding the critical decisions on a direction to pursue when it comes to potentially malignant melanoma.

Gary Goldenberg, MD is an Assistant Professor of Dermatology and Pathology at the Mount Sinai School of Medicine Departments of Dermatology and Pathology.

1. http://clinicaltrials.gov/show/NCT01011153