biomarker?
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Has anyone heard of Myriad Labs. . to announce that they have finished validating a melanoma biomarker and it is going to be marketed . . maybe late summer. . . and at that point we can ask a dermpath to run the test to rule out a false positive? Our scientific board does not feel this is a valid test yet, nor is it ready for prime time. Stay tuned. This was at ASCO and I actually hoped Cohanja wouldn’t see it! http://skinmelanoma.com/ The Scientific Board of MIF feels there is misinformation on the site and here’s the other comment from scientific board member: “
This is a not-ready-for-prime-time test that is being inappropriately marketed directly to patients and docs. I think we should tell patients that the field is moving toward finding more accurate and useful predictors of how melanoma is going to behave. These will surely involve both the “usual” melanoma and patient factors + patterns of genes that are turned on and off in an individual’s melanoma and in the rest of the person. When such a test looks promising, then it will need to be tested in clinical trials for its usefulness in choosing therapy (including the option of no therapy in low risk patients) and for its ability to pick therapies that change outcomes for the better.BUT, this test and the field are not yet there either in terms of the accuracy of the test OR IN KNOWING WHAT TO DO WITH THE INFORMATION.
To docs, I think we say that we should await peer-reviewed evidence of analytical and clinical validity + clinical utility–and the trials that study these.”
so this was not tested in clinical trials? isn’t that a legal requirement that it first be tested in clinicals before being approved/marketed? are their %’s accurate? 14% of Stage I and II patients are actually likely to metastasize
– Class 1, with a very low 4% chance of metastasizing within 5 years, or
– Class 2, with a high 72% risk over 5 years.
Did you see why I didn’t want you to get into this? Did you read what the scientific board said, lots of inaccuracies on their website and yes, they must have this go through much larger numbers in clinical trial before it can be approved. What will patients do with the information if it is accurate? Lots of questions but few answers yet. Actually, Catherine, this is not the one I was initially wondering about. . . I can see not recommending this one, because of all the reasons that you cited. The one I was talking about will be marketed by Myriad and will be available the beginning of 2014. That test has been validated and revalidated.. . . it will be used by academic dermpaths throughout the country.
This test is for the genetic marker for melanoma, which affects less than 4% of the population. However they state it is 10% and then give notations/footnotes to studies about colon cancer: http://www.myriad.com/treating-diseases/melanoma/ Unless there is something different you are talking about. Please read my blog, Buyer Beware,
http://melanomainternational.org/2013/05/melanoma-patients-and-their-caregivers-buyer-beware/#.Uc3uNvXD-t8 these expensive testing firms are not covered by insurance for the most part and can’t tell you more than a good university lab.
The link you highlighted is for Myriad’s p16 test. They are the same company which is validating a marker to determine which people diagnosed with melanoma will progress. I think the marker is applicable for Stage III (in terms of which patients will become metastatic) and I believe there is another marker for earlier stage melanomas but I wouldn’t swear to it. 10% is the number that most people (American Cancer Society for example) use as the % of melanomas that are hereditary. Only some of those 10% though have the p16 mutation where is where the 4% number may come into play.
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