FDA accepts Electro-Optical Sciences' PMA application for melanoma detection system

Aug. 6, 2009

AUGUST 6, 2009--Electro-Optical Sciences (Irvington, NY) says the U.S. Food and Drug Administration (FDA) will expedite processing of its pre-market approval (PMA) application for MelaFind, the noninvasive system designed to aid in the early detection of melanoma. FDA approval is required for marketing MelaFind in the U.S.; the system acquires, displays and analyzes multi-spectral images of pigmented skin lesions to aid decision making for skin cancer biopsy.

AUGUST 6, 2009--Electro-Optical Sciences, Inc. (EOS; Irvington, NY) (NASDAQ: MELA) says the U.S. Food and Drug Administration (FDA) has formally accepted the company's pre-market approval (PMA) application for MelaFind, its noninvasive computer vision system designed to aid in the early detection of melanoma. The FDA's action means that the PMA application was sufficiently complete and ready for substantive review; the FDA confirmed that the application will receive expedited review and processing.

"This brings us one step closer to realizing our goal of offering clinicians a reliable tool to help them to detect melanoma while it is still in its earliest, most curable stages," said Joseph V. Gulfo, M.D., President and CEO. The company is eager for the agency's feedback and for the next steps in the review process. FDA approval is required prior to marketing MelaFind in the United States.

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. According to EOS, 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.

EOS cautions that it cannot predict either the timing of the FDA's decision on the PMA application or the outcome.

Melanoma is the deadliest form of skin cancer, responsible for approximately 80% of skin cancer fatalities. The melanoma rate has continued to increase with an estimated 120,000 new cases projected in 2009. A recent National Cancer Institute report published in the July 10, 2008 online edition of the Journal of Investigative Dermatology indicates that annual incidence of melanoma among young adult Caucasian women rose 50% between 1980 and 2004. Melanoma is the most common cancer in women age 25 to 29 and the number one cancer killer of women age 30 to 35. Although no cure is currently available for advanced-stage melanoma, if caught early, melanoma is virtually 100% curable.

For more information visit Electro-Optical Sciences' website.

Posted by Barbara G. Goode, [email protected], for BioOptics World.