subject: Skin Cancer Detection Device, MelaFind, Gets FDA Panel Backing, Only Just [print this page] Skin Cancer Detection Device, MelaFind, Gets FDA Panel Backing, Only Just
Skin Cancer Detection Device, MelaFind, Gets FDA Panel Backing, Only Just
MelaFind, a device that helps dermatologists detect suitable samples for skin cancer biopsies has been approved by the General and Plastic Surgery Devices Panel, which advises the FDA (Food and Drug Administration). The vote, 8 in favor and 7 against approving the device, only just got through - there was one abstention. While some felt the device could be useful and a potential lifesaver, others wondered whether it could reliably detect more cases of fatal skin cancer.
Even though the Panel's recommendations are not binding, the FDA tends to go along with what they advise. However, the FDA had given the device a negative review, indicating a lack of willingness to approve it. Earlier this week one of the documents used in preparation for the meeting included the phrase that the device "may do more harm than good".
Joseph V. Gulfo, MD, President and CEO of Mela Sciences, the makers of the device, said:
We are extremely pleased with the results of today's panel vote and look forward to working with the FDA during its ongoing review of the MelaFind PMA application. Melanoma is virtually 100% curable if detected at its earliest stage. The unfortunate reality is that one person in the US dies from the disease every hour and it's the number one cancer killer in women ages 30-35. We designed MelaFind to provide clinicians with objective information that can aid their decision on whether or not to biopsy a pigmented skin lesion that has characteristics of melanoma at its earliest stage."
This is encouraging news for Mela Sciences which has no other product on the market.
According to Mela Sciences web site, in clinical trials MelaFind's sensitivity was over 95%, a statistically significantly higher detection rate than that of study dermatologists. The device is designed to assist in the evaluation of pigmented skin lesions, including atypical moles that have at least one clinical or historical characteristics of melanoma, therefore a final decision to biopsy has been rendered. MelaFind displays digital images of pigmented skin lesions and uses state of the art technology to help identify lesions that should be considered for biopsy to rule out melanoma.
MelaFind is a portable, hand-held device made up of an illuminator that shines light at 10 different wavelengths, including infrared, a lens system consisting of 9 elements that create images of the light scattered back from the lesions, a light (photon) sensor, and an image processor that uses proprietary algorithms to extract several discrete features from the images.
Put simply, MelaFind is designed to help physicians detect melanoma. It is not meant to be a screening device.
The FDA, which described the studies so far as "exploratory", is asking for two further studies to be submitted. There is concern in the FDA that the device has not been studied adequately for its current indications and use.
Dermatologists currently use a specialized magnifying glass to identify unusual skin lesions. The specialist then chooses which samples should be taken for biopsy. According to Mela Sciences, their device reduces the number of unnecessary biopsies.
According to the FDA, although the device was able to reduce the number of unnecessary biopsies, it did miss a couple of melanoma (true positive) cases in quite a small study.
Some media reports indicate that due to lack of resources, launching a new trial may be difficult for Mela Science, without the help of a new partner or raising more cash.
There is some concern in the FDA about whether the device might not be harmful if its use becomes popular among non specialists.
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