Thomas M. Burton of the Wall Street Journal shares news about a new tool with the potential of improving physicians' ability to diagnose melanoma, the most deadly form of skin cancer. In his September 26th article, he also addresses problems with the FDA approval process for new devices.
The accuracy rate of the typical dermatologist is ~80%. This means that 20% of the time a dermatologist either predicts cancer when the lesion is benign (false positive) or predicts benignancy when the lesion is cancer (false negative).
MelaFind is a specialized camera that takes pictures of a skin lesion at various depths and then compares the pictures with thousands of pictures of lesions with definitive diagnoses. In a study involving 1,383 patients, MelaFind bested dermatologists, making the correct diagnosis in 98.3% of cases.
The FDA sent an "approvable" letter to MelaFind's maker, Mela Sciences, after a 7-year battle. Last year the FDA rejected the device, claiming Mela Science first needed to conduct a larger study. The case went before the House of Representatives, where "the FDA's top device regulator, Jeffrey Shuren, acknowledged the agency had mishandled the MelaFind application."
Weeks ago, MelaFind received marketing approval for the device in 27 European countries. American physicians may begin using the device as early as early next year.
I usually avoid battle imagery in the context of Healthy Survivorship. But in this case, unfortunately, it has been a battle for FDA approval.
This new technique sounds very promising. I hope it saves lives in the end. That's the ultimate goal, isn't it?
Jan
Posted by: Jan Hasak | September 28, 2011 at 01:27 PM