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November 19th, 2010
09:38 AM ET
Device could detect melanoma without cutting skinDoctors may have a new tool for diagnosing the deadly skin cancer melanoma with cutting the skin, after a Food and Drug Administration advisory committee on Thursday recommended approval of the device. The machine, called MelaFind, is intended to examine lesions that doctors think have one or more characteristics of melanoma. Today, most lesions that look cancerous are biopsied. Many of those lesions turn out to be non-malignant. With a MelaFind, a dermatologist can scan the lesions, relying on the machine to identify early melanoma. If the machine does detect cancer, the doctor can proceed with a biopsy, but if the machine finds the lesion to be noncancerous, the patient does not have to go through unnecessary surgery to the skin. The manufacturer of the device conducted the largest prospective study ever in melanoma detection to show that MelaFind has higher accuracy identifying early melanomas than the highest rate of doctors ever recorded in the clinical literature. They also wanted to confirm that the extremely high accuracy wouldn't come at the cost of more unnecessary biopsies for patients, so MelaFind had to be better at ruling out melanoma that the doctors who participated in the study. Melanoma, which is the deadliest form of skin cancer, has an extremely high fatality rate when it's caught in its latest stages. According to the American Cancer Society, one American dies each hour from melanoma and the number of cases is growing fastest among young women. So early detection is key. “We are extremely pleased with the results of the panel vote and look forward to working with the FDA during its ongoing review of the MelaFind PMA application,” said Joseph V. Gulfo, M.D., president and CEO of MELA Sciences. “Melanoma is virtually 100 percent curable if detected at its earliest stage." Although this is only a recommendation from the committee to the FDA, traditionally, the government agency follows those recommendations.
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Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.
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Device could detect melanoma without cutting skin (headline)
Doctors may have a new tool for diagnosing the deadly skin cancer melanoma with cutting the skin...(first sentence)
CNN EDITORS, PLEASE DO YOUR JOB: "Doctors may have a new tool for diagnosing the deadly skin cancer melanoma with cutting the skin..." Oh, please. I see mid-edited stories on CNN.com at least once daily, often more than that. I'm shopping around for a different online news service.
You tell them!
this is old news too!!!
And your point is?
So how does the machine work? This is clearly little more than a corporate press release with a lede tacked on.
Here is another article that I found on this topic. http://www.massdevice.com/news/fda-melafind-skin-cancer-biopsy-replacement-may-cause-more-harm-good
I agree that this "news" seems like it came straight from the mouth of the company that makes the device. Coincidently I also saw something about their stock doubling after the vote.
the fda committee vote was split 8-7, not a resounding endorsement
If you had listen to Piper Jaffray conference, you would know that 3 more panelist would have voted yes with labeling stating for Derms use only. This is something that MELA wanted from the beginning and the FDA directed physicians. If my math is correct, that would have been 11 yes, 4 no and 1 abstain. Just another short on MELA I presume?
with melanoma present in my family, taken my aunt, almost my mother and my baby sister in Stage 4 with experimental treatments any new tool is welcomed if accurate. this cancer is a dealy chameleon and i know all too weel with several tumors removed. As an avid surfer/skier and sun lover i offer this. Wear sunscreen always, check out any mole change or skin cahnge with your dermo and most of all STAY OUT OF TANNING BEDS.....
Thank you, Tom. Please speak out for the men to hear. They will listen to you much quicker than any woman in their life. Thank you.................. from a melanoma cancer survivor.
Tom – I am sorry to hear about your personal experience from this disease. I try to spread the word to everyone once a year to be diligent about sunscreen and dermatological screenings. It is a devastating disease. See my post later in this thread about a new tool that is NOT getting the attention it deserves. It found my 2nd melanoma. It works and is relatively inexpensive.
Why haven't they approved Clinuvel/ melanotan – could protect millions!
I am glad that there are new diagnostics available. My dad is currently on his death bed. He was diagnosed 4 weeks ago with stage 4 melanoma. It took him so fast with no treatment available to him because at the time of diagnosis it was too far advanced.
I agree with aminmd. Whoever proofreads or edits these news blurbs must have been asleep.
The headline referred to without cutting the skin. The text referred to cutting the skin.
Too many of these errors the past year.
Wake up CNN or take yourself off the web.
CNN wants to become the new comedy network?
CNN is more interested in "shock" stories than actually getting a story/article correct.
How can anyone watch HLN with the exception of Robin Meade? and she is caving too.
How can a story be "breaking news" about a murder that happened in 2005?
Bernard Shaw saw this coming and was disturbed.
it keeps me laughing!
Proofreaders Anonymous members: If you have nothing to say about the topic at hand, please move on. Those of us who have, or have survived, this deadly cancer don't appreciate your worthless comments. They interfere with an informative and potentially life-saving discussion.
Many years ago, as a 21-year-old, fair-skinned female, I was diagnosed with melanoma. The only diagnostic tool available at that time was biopsy, and if positive, surgery was often the only option. After a melanoma diagnosis and following my oncologist's recommendation, I underwent radical excision surgery.
It's been exciting to see the advances medical research has made in the diagnosis and treatment of melanoma since that time. Should I find another potential melanoma, I might try one of the newer diagnostic methods, but only IF my insurance will cover the costs of the new method AND the biopsy, which remains our best diagnostic tool.
I've never had a melanoma (so far), but have had quite a few basal cell carcinomas. The presence of a BCC is always confirmed by a biopsy, which, at least in the case of a BCC, is no big deal - really, a tiny, tiny deal. Possibly a biopsy for a suspected melanoma is more serioius. So, I am not sure what the fuss is about. What is really needed is effective treatment for any beyond Stage 1 or Stage 2 melanomas. There are promising treatments in the pipeline, but as far as I know, none that will convert post-stage 1 or 2 from a death sentence to a manageable disease. One of my closest friends died of Stage 4 melanoma after a 15 month battle. Melanoma is exactly what I would wish on my worst enemy.
I am all about early detection. On my 29th birthday I had radical surgery for stage 3 melanoma. Not only did they remove the tumor on my leg, cut a huge chunk from my calf, did a graft with skin from my left ass cheek, but they also took 17 lymph nodes from my groin area and b/c of that, I live with a leg twice the size of my other one. I also went to Duke University 4 times for immunotherapy, shots that made me sick. yes, I am a cancer survivor, 22 years now, this new melanoma detector is innovative; however, if your tumor is malignant, your life will never be the same. they will cut you and you might die. a biopsy is nothing compared to the full-on treatment. So my point is, hooray for the people who are benign but what can be done for those who really have melanoma? I am fair, blonde hair, blue eyes with a celtic heritage. BUT, anyone can get it. Wear sunscreen everyday and stay out of the tanning beds. Americans think tan=healthy. we need to educate, educate, and let these kids realize that your skin is damaged when it changes color b/c of the sun. Besides, it also ages you really fast. Check your moles and freckles and follow the ABCD rule. Thanks for letting me vent.
Thank you, Amelia, for your post. I, too, was cut on, but the malignancy was removed. Not to the lymphnodes for me. So, early detection is surely the key. I won't be trusting a new contraption. I want the lab to SEE the cells. I want a biopsy if anything suspicious shows up. It just isn't worth the chance. YES we need to redefine beauty in the U.S. Tan means injury to your skin. Pure and simple.
Amelia – Yes, education is the key to catching melanoma in its early stages. And I agree that a cancer diagnosis can change your life. At 21, it forced me to grow up – not a bad idea at the time. I felt, and acted, like a victim for far too long. But with the help of an amazing therapist, I now see myself as a survivor.
Many of us are disfigured by the "battlescars" of radical excision surgery. For 35 years, I've lived without a large piece of my back. But I'VE LIVED.
How cool that you have two "birthdays" to celebrate at once! I may be 56 years old on Thanksgiving Day next week, but I'll be celebrating my 35th birthday.
This sounds like some press release from the company, more like an advertisement than a news report.
How is the skin examined? Is it with an X-Ray? Some type of scan? Are there any risks? What is the rate of inaccuracy? These should be questions a journalist would ask, I don't see any of that.
I think we need a new (and separate) "slam CNN" discussion board, so you guys will stop gumming up the discussions on the actually topic.
Ok, there are errors in the editing of the stories, move on! There are people who read these stories because the are living with melanoma or have survived this potentially deadly cancer like myself. Everyone is entitled to their opinions, but when I read comments, I'm am looking to ones that I can relate too, ones that may give me some information I may not know, or ones that may give me hope. A year ago, I was diagnosed with melanoma and had surgery to remove it. I now have a baseball sized indent on my leg and see a derm every 3 months. I live in constant fear that this disease will reappear somewhere else...I want to yell at people who walk into tanning begs, or bake out in the sun. Protection from the sun between 10am and 4pm is the best defense and even people who do not have a history of skin cancer should see a derm about once a year. I am fair skinned, but dark hair and do not have a family history, but I was also not careful protecting myself and have learned the hard way.
As part of a large group of people who treat these lesions(28 years)..this is a godsend for early diagnosis. Sure,there was a typo in the beginning...so what ! Ask anyone who could have a potentially curable and ,if left alone fatal,disease evaluated with very high credibility if they'd do this and the answer would be yes. Ask anyone who has to wait a week for a path result, whattheir week is like. And in the presence of a false positive ,then the usual biopsy can be done.Even the best derms are only 80% possibly right and this is closer to 99%. What is the questioning for ???? I don't get it!
Barry – please see my post about another diagnostic tool, that had results for me!!
As someone who has been diagnosed twice with melanoma, this is great news. However, there is also another viable option called MoleSafe. It is a simple process of photographing all lesions/moles/freckles on your skin (from 1 to 100+) and then getting a light infused close up (Lens on the skin and bright lights on the lens allows doctors to see what changes are going on beneath the surface), photos are then stored and reviewed year-to-year for changes and then a dermatologist reviews the pics and lets you know which ones should be watched, excised, etc. THIS TOOL FOUND MY 2nd MELANOMA – when my surgical oncologist and dermatologist weren't concerned with that spot, so this is like having a 3rd pair of eyes watching my skin. At a cost of $400, I think it is a very valuable tool at not too steep a price.
I am not associated with this company other than as a patient. I BELIEVE in its value. You can go to their website and see which clinics offer this service and when a traveling Molesafe office will be in your area. http://www.molesafe.com – it was developed by people in New Zealand where skin cancer occurs in 2 out of 3 people due to their proximity to the sun. If you have questionable places, get in to see a dermatologist.
If you are a dermatologist, you can buy a license to operate the Molesafe process in your office. This kind of technology needs to be in more hands to prevent more advanced cases!!
For all the MELA naysayer out there, why is there support from the Archives of Dermatology which is publishing an independent report in Feb that says Melafind would be an effective tool for Dermatologist to use. They are someone who I suspect know a thing or two about Dermatology and not some Kool Aide drinkers who are shorting the stock, hoping it will go down.
Greetings all!
It's interesting, I was at a meeting of the Melanoma Research Alliance and heard a renowned physician report that while many other cancers had genetic pathways that could be shut down; melanoma had far too many pathways that the cancer could take to mutate and metastasize. Early detection is the real hope for this disease. Catch it early, survival rates are nearly 100%. Catch it at stage 4; and it's all but lights out. I don't mean to sound callous – those are the facts.
While a biopsy may not be a huge medical procedure, there are chances for missing the disease due to something called sampling error. New diagnostic devices can make a big difference in how the disease gets managed along with the follow up treatment. There are other devices out there that already have FDA approval for the diagnosis of skin cancer – check out http://www.lucid-tech.com for an example of just one of these devices...
Big help, big help. And surpelavtie news of course.
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