Good news for anyone worried about skin cancer with the FDA approving Melafind, which the manufacturers describe as a groundbreaking technology for detecting melanomas.

Darrell S. Rigel, MD, Clinical Professor of Dermatology at New York University Medical School confirmed the news :

“MelaFind is a groundbreaking technology and represents one of the most significant advances in early melanoma detection since the advent of the ABCD criteria that our group developed over a quarter century ago … While there have been incremental improvements in imaging tools for melanoma detection, we still primarily rely on our eyes, experience and judgment. MelaFind provides objective information about indeterminate pigmented skin lesions to help us when deciding which lesions to biopsy to detect melanoma as early as possible when it can still be cured.”

Melanoma is the deadliest form of skin cancer because it more easily and aggressively spreads to other parts of the body. It accounts for around 75% of all skin cancer mortalities and although its virtually curable if detected early, the skin obviously being one of the easiest parts of the body to treat, the problem remains with catching it early enough.

Joseph V. Gulfo, MD, President and CEO, MELA Sciences said :

“The FDA approval of MelaFind marks the most important achievement in the company’s history and represents a significant advance for the millions of Americans who are at risk of developing this terrible disease … We are actively working to prepare to launch MelaFind in the Northeast U.S. and Germany during the first quarter. We’re planning a steadfast, deliberate and measured approach to the commercial launch to ensure that dermatologists in practices of all shapes and sizes are trained and set up to use MelaFind effectively on the patients who can benefit most from the objective information that the system provides during skin examinations.”

Melafind also received CE approval for release in Europe where the company plans a similar roll out strategy as for the North America.

MelaFind is not an overall confirmation system in itself and is not meant for a complete clinical diagnosis of melanoma. What it represents is another tool in the dermatologists kit and is designed for use on clinically atypical cutaneous pigmented lesions with clinical or historical characteristics of melanoma. MelaFind is designed to be used when a dermatologist feels the need to obtain additional information for a decision to biopsy.

MelaFind is not meant for use by the general public as a physician needs to be trained in the clinical diagnosis and management of skin cancer (i.e., dermatologists) and also complete a training program in the use of MelaFind.

None the less it represents a significant breakthrough in the fight against skin cancer. With the five year survival rate for patients with stage IV melanoma at less than 15%, and with most patients dying within six to 10 months, detecting early melanoma and conducting prompt treatment is essential to improving the prognosis. With detection of early melanoma, surgical removal alone is usually the only required treatment because the melanoma is limited to the epidermis, the outer layer of skin. In this early stage, the cure rate with surgical removal is virtually 100%.

The markets are obviously confident of the product with the stock of Mela Sciences (MELA) up more than 10% in trading today.