Skin Cancer Detection Device
Compiled by Walter Sorochan

Skin cancer is the most common form of human cancer. It is estimated that over 1 million new cases occur annually. The annual rates of all forms of skin cancer are increasing each year, representing a growing public concern. It has also been estimated that nearly half of all Americans who live to age 65 will develop skin cancer at least once.

The most common warning sign of skin cancer is a change in the appearance of the skin, such as a new growth or a sore that will not heal. Types of skin cancer:  Basal cell carcinoma is the most common. Melanoma is less common, but more dangerous.

Skin cancer can be prevented and when detected early, can be treated successfully.  This article focuses on providing information about prospects of improving early detection. 

 MelaFind, is a skin cancer detection device that maker Electro-Optical Sciences [ EOS ] is hoping for FDA approval in 2010.  

 MelaFind is also referred to as "Algorithm Gun.” 

eos deviceThis is a handheld cancer detection device, which effectively takes a super-fancy 3D photo of skin lesions, records that data on proprietary memory cards that are patient-specific, and compares it to their library of skin cancer pics to see what the likelihood is that this particular lesion is cancerous or worthy of aggressive treatment.

Technology used:  C-VS Tech or Computer Vision Systems Technology. 

Computer vision is the science and technology of machines that see.  Computer vision is the branch of artificial intelligence that focuses on providing computers with the functions typical of human vision. To date, computer vision has produced important applications in fields such as industrial automation, robotics, biomedicine, and satellite observation of Earth. In the field of industrial automation alone, its applications include guidance for robots to correctly pick up and place manufactured parts, nondestructive quality and integrity inspection, and on-line measurements.

Applications include:  human recognition of fingerprints, eyes, faces, voices, DNA, video surveillance, recognize of behavior, detection of body disorders like skin cancer, airport check for weapons, poultry industry, military applications & so on. 

 Electro-Optical Sciences is a medical technology company focused on developing MelaFind, a non-invasive and objective computer vision system intended to aid in the early detection of melanoma. EOS designed MelaFind to assist in the evaluation of pigmented skin lesions, including atypical moles, which have one or more clinical or historical characteristics of melanoma, before a final decision to biopsy has been rendered. MelaFind acquires and displays multi-spectral (from blue to near infrared) digital images of pigmented skin lesions and uses automatic image analysis and statistical pattern recognition to help identify lesions to be considered for biopsy to rule out melanoma.

FDA:  used a guideline in 2009 called "PMA/510(k) Expedited Review," to essentially speed up the review process for this new device for diagnosing a life-threatening disease on assumption that it "represents a breakthrough technology that provides a clinically meaningful advantage of existing technology."

To evaluate a biomedical-screening device like the "Algorithm Gun", you must answer two questions:

1) Does the device catch the disease (the sensitivity)?
2) Does it also tell you who's disease-free (the specificity)?

In a preliminary study of 352 lesions, this company’s device correctly identified all 28 cancers. And in all tests so far, the company’s device has correctly diagnosed cancer in 98% of the cases, compared to the 60% to 70% rate doctors are able to identify the disease using the ABCDE method.

 The MelaFind device is apparently going to be priced at about $2,500.  Projected cost to public will probably be $100 to $200. 

solarscan02 australia Competitors: 

Similar product (SolarScan) has been around in Australia & USA for a couple of years – that stock last traded for .130(A$) – code PLT.  Polartechnics claims an 83 percent accuracy rate using the Solarscan, approaching 100 percent if the lesion is monitored over a period of three months. More studies are being conducted to confirm these claims.

ABCD's of melanoma:

The simple ABCD approach is a useful guide to help you identify moles you should show your doctor:

abcmelanoma

Stages of melanoma:

There are four stages of melanoma that classify the severity of this skin cancer. Each stage pertains to the thickness and the amount that the melanoma has spread. When the stage of melanoma has been diagnosed, it is then possible for the doctors to determine the best type of treatment. In this article, we will discuss what the different stages of melanoma signify. We will describe each of the four stages in further detail. Hopefully, after reading this article you will have a greater knowledge of the skin cancer disease known as melanoma and the four degrees associated with it.

Stage 1 of melanoma is thin and the epidermis usually appears scraped. This stage of skin cancer is subdivided into two other categories. These additional categories describe the thickness of the tumor. Stage 1a is less than 1.0 mm and has no ulceration. Stage 1b is less than 1.0 mm but has ulceration. It is also considered to be in stage 1b if it is 1.01 - 2.0 mm even if it does not involve ulceration. In this stage and stage 2 the melanoma has not yet spread to the lymph nodes.

Early Stages of Melanoma
early stages melanoma


Stage 2 is also subdivided into three more categories that signify the thickness and the existence or non-existence of ulceration. The tumor in stage 2a is 1.01 - 2.0 mm with ulceration or 2.01 - 4.0 mm without ulceration. Stage 3b has a tumor thickness of 2.01 with ulceration or a thickness of more than 4.0 without ulceration.

When this type of skin cancer advances to stage 3 a significant change occurs. At this stage, the melanoma tumor has spread to the lymph nodes. This is a much more serious stage of the disease because when healthy, the lymph nodes fight disease, cancer and some other infections.

Patients with stage 3 of this cancer have melanoma that has spread into lymph nodes near the primary tumor. This stage also involves in-transit metastasis that has skin or connective tissue that is more than 2 centimeters from the original tumor. However, at this point it has not spread past the regional lymph nodes.

In stage 4, the melanoma has spread to lymph nodes that are a distance from the original tumor or to internal organs. These organs are most often the lung, liver, brain, bone and then the gastrointestinal tract.

When diagnosed with skin cancer, it is important to consult with your doctor concerning the degree or stage of melanoma that you may have. A variety of diagnostic techniques will likely be used to determine the stage of your skin cancer. Most stage 1 and stage 2 melanomas should not cause too much worry because they can most often be cured through surgery. There is little need to worry about getting later stages of melanoma just because you once suffered through the early stages.

Different doctors may use different systems or scales to classify the stages of melanoma. The most commonly used are the TNM staging system and the Breslow scale. The most important things to remember are that melanomas with 0.76 mm or lower thickness are low risk, 0.76 - 1.5 mm involve medium risk and when the melanoma is more than 1.5 mm in thickness you are at a much higher risk. When you are diagnosed with melanoma it is important that you understand exactly what stages your doctor may be referring to and what treatments are available to you. 

 Reference:  Mike Havrilla, FDA Calendar Updates: ViroPharma, Electro-Optical Sciences, Wyeth, Progenics. August 05, 2009.
 
Web: http://seekingalpha.com/article/154027-fda-calendar-updates-viropharma-electro-optical-sciences-wyeth-progenics