Here at the MRF, we talk a lot about skin checks. The message is clear: if you see something that is different or changing, get it checked out.

 

Of course, it isn’t that simple. Who checks it out makes a big difference. In one study, primary care physicians identified suspicious lesions only 71% of the time. Dermatologists were at 94%! Even among dermatologists the variations are significant. One group tested the thoroughness of skin exams, and found only half of exams conducted by dermatologists were sufficiently robust. 

 

Several companies are trying to bring technology to the aid of dermatologists. Some are thinking of marketing to primary care physicians or even to consumers directly. At the recent annual meeting of the American Academy of Dermatology I was able to connect with a number of these companies. Here is a summary:

 

3Gen makes the Dermlite, a widely used dermatoscope. The device uses polarized light to remove any reflection from the skin surface. This allows doctors to examine the skin more thoroughly than can be done with a simple magnifying glass. The company is now close to launching a dermatoscope that is tied to smart phones and can be used by patients. The price point will be about $100. Patients will be able to track their lesions over time, and show any changes to their dermatologist.

 

Castle Biosciences has offered for some time an evaluation of primary tissue in ocular melanoma that is highly predictive of the likelihood of metastasis. The test looks at genetic profiles of patients. Those profiles fall into two broad classes: Class I patients rarely experience metastasis and Class II patients almost always experience metastasis. Castle now has a similar product for cutaneous melanoma. So far they have only done small studies, but the test seems to hold up well. They tested a group of Stage I and II melanoma patients. Those who tested as Class 1 had a 5-year metastasis-free rate of 97%; those who tested Class II were at 31%. They also looked at patient who had sentinel-node biopsy (SLNB). In that study, the Castle test was more accurate than SLNB than predicting response.

 

DermTech makes a small adhesive strip that is placed on a suspicious spot. When the strip is pulled off the skin it brings with it genetic material from the skin surface. This strip is then sent to the laboratory, where the genetic material is analyzed. The company has identified two genetic markers that are highly indicative of melanoma. This product may be available to dermatologists later this year.

 

MelaSciences has the only device that has been approved by the FDA, called MelaFind. The approval process was challenging and resulted in a very limited scope of use; the device can only be used by dermatologists. MelaFind takes a series of images of a lesion, using different wavelengths of light. Each wavelength penetrates deeper into the skin and the result is a 3-dimensional model of the lesion. This then is evaluated by an algorithm that shows the likelihood of the lesion being melanoma. 

 

MoleSafe does whole body photography and dermoscopy. The most important factor in identifying suspicious lesions is change, so their system makes available serial dermoscopy images. They create a report that shows whole-body images, with areas of particular concern identified in detail. For those places they can show dermatoscopic and microscopic images. This record is in the cloud and is available to patients at any time. If a patient moves or changes doctors they still have access to the record and can show the images to their physician. 

 

Myriad Genetics made their mark doing the BRAC test for breast cancer. They are now rolling out a test for melanoma that is highly definitive. The test has been through analytical validation and clinical validation, and may be commercialized later this year. It is designed to supplement the work of a pathologist, not replace it. The physician takes a biopsy and then the pathologist looks at the tissue and identifies areas of particular concern. They pull seven samples from that tissue and do PCR , looking for a profile of 25 different genes. This profile is sufficient to distinguish melanoma from normal tissue.

 

SciBase is a Swedish company that has a device designed to test for melanoma by measuring the impedance (electrical resistance) in the skin. Normal skin tissue is comprised of highly organized cells. In melanoma tissue the cells are highly disorganized. This creates a variance in the impedance. SciBase has a probe with many very small barbs that is placed on the skin. These barbs measure impedance and provide a report on the likelihood that the place being tested is melanoma. In a study of more than 2,400 lesions they found 265 melanomas, with an accuracy rate of 97%. The SciBase system is approved in Europe and Australia, and they are working on approval in the United States.

 

Whether these companies will be successful or not remains to be seen. Success will rely on having a proven technology, offering it at an appropriate price point, and finding a way to have this approach embraced by the dermatology community. I suspect, though, that five years from now evaluating a suspicious spot on our skin will be done in a way quite different from what is currently practiced.