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How will the DDx change my experience in the doctor’s office? 
Important facts about SKIN CANCER
In 2014, there were over 3.5 million cases of basal cell and squamous cell skin cancers diagnosed in the US, and over 76,000 cases of melanoma. Melanoma is aggressive and deadly. Of the 13,000 skin cancer deaths annually in the US, melanoma accounts for around 9,700.

Symptoms of both non-melanoma and melanoma skin cancers include a change in the size or color of a mole, growth or spot on the skin, a new growth, a change in skin sensation, and a spread of pigmentation outside the border of a mole or mark on the skin.

Currently, skin cancer is diagnosed by a dermatologist, sometimes using a dermoscope. The device shines polarized light on the skin and magnifies it. The dermatologist looks at the pigment and structures in the skin, and any suspicious lesion is removed from the skin and further analyzed in a 
histopathology laboratory by a specialized pathologist. A dermatologist selects treatment after considering the type of skin cancer and stage of the cancer (how deeply the skin cancer has grown and how widely it has spread).

Treatment strategies involve surgical removal, usually by either by single excision or Mohs surgery. Alternative procedures include curettage (scraping) and electro-desiccation (a localized electrical treatment to assure complete removal of cancer tissue), primarily used to treat small basal cell and squamous cell skin cancers. Other possible treatments are immunotherapy, cryosurgery, chemotherapy applied to the skin, or photodynamic or radiation therapy.

​According to the American Cancer Society, melanoma patients’ overall 5-year survival rate is 98% if their melanoma is detected early. Later, after the tumor has spread to regional lymph nodes or other organs, the survival rate falls to 62 percent. If the cancer is neglected long enough that it metastasizes to distant organs, the 5-year survival rate drops to 15%.

Skin Cancer Outcomes
TODAY: 
 In the doctor’s office or clinic, the doctor first visually inspects the patient’s skin to see if there are any unusual spots, moles, or discolored patches on the skin that might be suspect as possible skin cancer. Sometimes a hand-held device called a dermascope will also be used for this. It allows visual inspection of the area of concern magnified and under polarized light, assisting the doctor to see features of the suspect tissue. The doctor will surgically remove any suspect lesion (or a part of it) to send to a histopathology laboratory. There it will be inspected by an expert pathologist who will determine if the excised tissue is from skin cancer, and if it is, what kind of cancer it is (Melanoma, Basal Cell Carcinoma, or Squamous Cell Carcinoma, for example). This will be reported back to the doctor who will evaluate the information and then contact the patient to report the pathologist’s finding. This process normally takes several days to a week or more. If the tissue is cancerous, then a full surgical excision will be scheduled. 
WITH THE DDx
If the doctor finds a suspicious spot the process will be different. The DDx employs a small hand-held diagnostic probe about the size of a ballpoint pen. This “light wand” will be touched to the spot to be tested for about 5 seconds while harmless light is shined on the skin and the light reflected back is collected and measured. This is a painless procedure. Immediately after this measurement, the DDx will provide the doctor with an analysis of the data collected in that time from the three optical methods. That data will classify the tissue as either benign or likely to be cancerous. If the suspicion of cancer remains after this process, only then will tissue be surgically excised and sent away for histopathological examination. The DDx is very accurate, but pathology is the “gold standard” for cancer identification. Using the DDx is expected to reduce the number of times suspicious but actually benign tissue is excised to a small fraction of today’s procedure.
EARLY DETECTION IS IMPORTANT!
  • Caught early and properly treated, skin cancer can be cured. Even melanoma, which can be deadly, has a cure rate of almost 100 percent when diagnosed and treated early. 
  • Once a person gets skin cancer, the risk of getting another skin cancer is higher.
  • Without early treatment, the outcome is not as favorable. 
  • If not found early, skin cancer can grow deeply. Removing the cancer can mean removing muscle and even bone. Reconstructive surgery may be needed after the surgery to remove the skin cancer. 
  • Skin cancer can spread. If the cancer spreads, treatment can be difficult and may not cure the cancer.

COMMON TYPES OF SKIN CANCER

  • Actinic keratosis (AK)
  • Basal Cell Carcinoma (BCC)
  • Melanoma
  • Squamous Cell Carcinoma (SCC)

DDx is not yet approved for sale in Europe and US.