A new device called MelaFind was approved by the FDA this week. This device includes a scanner and a computer program that analyzes images of skin lesions. Apparently, MelaFind missed only about 2% of those spots that were later biopsy-proven to be melanoma...an amazing success rate!
According to one article, one drawback is that the device has a high rate of false positives. About 90% of the time, spots that MelaFind identified as suspicious turned out to be benign. This seems alarmingly high and would cause undue stress on the patient, but apparently a panel of dermatologists had an even higher rate of false positives.
The FDA passed MelaFind by a slim 8 to 7 margin with the primary resistance being the high false calls. Ironically, I mentioned photo-mapping of moles to my dermatologist yesterday and he digressed into a few comments about the non-reliability of digital imagining techniques. It seemed that his opinion was that technology had not yet caught up to the trained eye. What this told me is that, despite this device being available for use, my dermatologist would most likely not use it. I would imagine other dermatologists would be hesitant as well.
So I suppose this is a good news bad news scenario. The good news is, doctors have another tool to assist in the fight and diagnosis of melanoma. The bad news is that it may lay dormant and rarely be used. Let’s hope whatever decision your doctor makes is the best decision for YOU.
Finally, the best news out of this…melanoma is once again a headliner in the medical news. This has been a banner year for development in the fight against melanoma, and any mention on the news helps raise awareness. Remember, the best weapons against this disease is awareness and prevention.
I agree with you, any mention gets Melanoma in the news!! It is kind of scary to rely on a machine, but another tool to identify a malignancy is better than none. I wonder what the costs are going to be and if they will be available to Dermatologist or just Melanoma Specialist.
ReplyDeleteInsurance won't cover it for several years
ReplyDelete- it's about $150 out of pocket. Only derms ( vs Primary Care Physicians) can use them per the FDA and only specially trained ones at that. Around 200 are being rolled out to start and only on the east coast.
According to medical news, "The FDA examined a pivotal trial involving 1,383 patients in the USA, as well as the companion reader study of 110 dermatologists. MelaFind was found to be 98% accurate in the trial, while dermatologists had a 72% sensitivity." So its scary to only rely on a dermatologists. This is a phenomenal machine that should be in every dermatologists office and if they don't agree to use this tool I'm sure there will be many Primary Care Physicians looking to jump on that product.
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