Clinical diagnosis of melanoma and other skin cancers is still performed primarily by sight. Since even the most sophisticated eye is fallible, there is a chance that skin cancer may be visually diagnosed as benign, while conversely a benign mole might be unnecessarily biopsied. As reported in the Journal of the American Academy of Dermatology, nearly 80 percent of all skin biopsies performed in primary care are benign.
The consequence of these circumstances is that patients must tolerate not only the chance of being misdiagnosed with skin cancer, but also endure the pain and potential subsequent scarring if a biopsy is deemed necessary by the physician. Further, patients may experience anxiety between the time a biopsy is performed and the time results are obtained, which can take up to two weeks.
Patients are often afraid to get suspicious lesions checked because they know the chances of being urged to undergo a biopsy are high. Additionally, many lesions occur on cosmetically sensitive parts of the body, such as the face, so apprehensive patients may decline to undergo the procedure at all.
Caliber Imaging & Diagnostics has developed a technology that may alleviate these concerns. Caliber I.D.’s VivaScope offers patients an “optical biopsy” that is both painless and noninvasive—meaning no cutting, no injury and no scarring takes place.
The VivaScope imaging procedure is designed to allow physicians to diagnose melanoma and other skin cancers at its earliest stage when it is most curable. The procedure captures high-resolution, zoomable images of the skin, providing doctors with a cellular view at varying depths under the skin surface. These images make it possible for doctors to determine if a spot on the skin is “nothing to worry about” or if it is a cancer such as melanoma or basal cell carcinoma. The entire procedure takes less than 10 minutes and collects all the images needed to make an accurate, reliable real-time diagnosis at the point of care.
VivaScope is one of the most fruitful applications of confocal microscopy, a noninvasive method for high-resolution diagnostics of tissue. While conventional microscopes work by using transmitted light technology, with thin tissue layers being illuminated from below, confocal microscopes designed for dermatology operate with incident light technology. The skin is illuminated from above, in the horizontal plane, with a focused laser. The light is reflected at interfaces where the refractive index changes. Highly reflective structures of the skin are keratin, melanin and collagen. The reflected light is directed through a pinhole onto a detector so that only signals from a defined horizontal plane are used for high-resolution imaging. The technique limits the penetration depth into skin, but typically provides physicians with enough information to determine if a biopsy is required or if the lesion can be monitored at future visits.
Examinations are possible noninvasively, in vivo and in real time. Confocal microscopy allows in vivo microscopic imaging of skin layers close to the surface, and opens up new possibilities for doctors to diagnose and monitor changes in the skin, in particular for monitoring benign moles for changes over time and for monitoring the response to noninvasive therapies at the cellular level. It also can be used ex vivo with freshly excised tissue, resembling a frozen section analysis, which is interesting especially for the field of microscopically controlled surgery of skin tumors.
In 2011, the Association of the Scientific Medical Societies in Germany published guidelines stating that confocal laser scanning microscopy is suitable for dermatological, noninvasive diagnostics of near-surface skin changes. The guidelines also note that in the area of skin tumors, it is especially of interest to assess melanocytic lesions with respect to their benign or malign character in order to enable the early detection of melanoma and to avoid unnecessary excisions.
As the only noninvasive skin imaging technology that offers the ability to accurately identify and diagnose all types of skin cancers through the direct visualization of cells, VivaScope holds promise for skin cancer patients and their doctors alike.
L. Michael Hone is CEO of Caliber Imaging & Diagnostics. He can be reached at firstname.lastname@example.org