According to the L.A. Department of Public Health, skin cancer is most common form of cancer in the United States and the third most common skin cancer is melanoma. Due to its Sun Belt location, Los Angeles has a higher rate of skin cancer cases than cities at more northerly latitudes. On September 22, the Food and Drug Administration (FDA) granted approval for a new device to diagnose this deadly cancer. The MelaFind device (Mela Sciences; Irvington, NY) is a new method for detecting and diagnosing melanoma; it is intended to help identify this cancer in a systematic way. A special camera captures an image of a skin area; then, a computer analyzes it using an algorithm developed via data from thousands of patients. The usual method of diagnosing melanoma is by analyzing a skin lesion according to certain criteria such as color, border irregularity, symmetry or asymmetry, and diameter. Many skin lesions are difficult to diagnose, even by a skilled dermatologist. Furthermore, the possibility of a “false negative” exists: failing to diagnose a cancer that actually exists.
Last year, the FDA last year rejected the device and requested that the company conduct a new, larger study because the one published in October 2010 did not adequately compare the device findings with those of dermatologists. Mela Sciences filed a citizen’s petition to overturn the FDA denial. The case was a focus of a recent House of Representatives hearing at which the FDA’s chief device regulator, Dr. Jeffrey Shuren, acknowledged the agency had mishandled the MelaFind application. He admitted, “The staff made the wrong call.” As a result, the FDA sent an “approvable” letter to Mela Sciences last week that canceled the need for an additional study. Mela Sciences’ device was shown to be 98.3% effective in identifying melanoma lesions in the trial the company commissioned. The study, published in Archives of Dermatology in October 2010, included 1,383 patients with 1,632 skin lesions.
The device resembles a desktop computer mounted on a rolling rack. The camera is held against a skin lesion and filters in the camera allow the device to produce images from various skin depths. These images then are compared with thousands of images in the company’s database. Mela Sciences plans to introduce the device in the U.S. in early 2012, starting in the Northeast. The test would cost approximately $50 plus the doctor’s fee for conducting the test. After MelaFind is on the market, the company plans studies evaluating cost cost-effectiveness; this would persuade Medicare to pay for the test. If that occurs, private insurers would probably follow suit.
UCLA cancer researchers studying combination therapies for melanoma
Malignant melanoma: UCLA announces new findings
Prevent skin cancer: drink wine
Ladies, sport a healthy tan and pamper your skin