First off, I am a lover of all things melanoma and especially research and new areas of development but I find myself at odds with the latest video from the Ask the expert series that was published this week. First I have looked and have not found any FDA approvals for this GEP (Gene expression profile test), thank you “Keymaster” for your link to Castle Bioscience the other day but asking for FDA approval information and giving me a link to Castle bioscience web page doesn’t quite answer my question to you, which was is this test FDA approved. Two articles that I will link below, one from “Journal of American Academy of Dermatology” with Guidelines for the care and management of Cutaneous melanoma with Jeffrey E Gershenwald Md as one of the authors on page 22 near bottom of page and on pg 23 talks about GEP test and do not approve of their use without prospective clinical trials. https://www.jaad.org/article/S0190-9622(18)32588-X/fulltext https://www.jaad.org/action/showPdf?pii=S0190-9622%2818%2932588-X
- April 23, 2021 at 11:01 am
Second link is article in JAMA Dermatology , Melanoma Prevention Working Group paper of use of GEP tests, July 2020 with Dr. Adil Daud ( a MRF Scientific Advisory Committee member ) as a co-author on paper. I will let you read their findings for yourself but they are similar to the first paper asking for prospective clinical trials. https://jamanetwork.com/journals/jamadermatology/article-abstract/2768743?fbclid=IwAR0yNWR8ZXqgufl1Vl49JOooBEILoE8YI5_EuH2cCo7-g62bpAPqiMqn4uI
- April 23, 2021 at 11:09 am
- April 23, 2021 at 11:25 am
I just posted on this topic on a prior thread – but perhaps it makes more sense to post it here – so….here’s a copy:
Hey Ed (and Lauren Johnston),
I too am confused! There is this: https://www.dfs.ny.gov/public-appeal/print-page/75216
There is also this patient report from CASTLE Biosciences themselves: https://castlebiosciences.com/wp-content/uploads/2015/01/Sample_CM_report.pdf
Which actually states – “This test not been cleared or approved by the U.S. Food and Drug Administration (FDA).”
Then there is this Re Decision Dx Uveal Melanoma info: https://www.evicore.com/-/media/files/evicore/clinical-guidelines/solution/lab-management/healthplan/decisiondx-uveal-melanoma.pdf
Within this document it clearly states that both DecisionDx PRAME and DecisionDx UMSeq are – “…considered investigational and/or experimental.”
None of this means that this test is necessarily worthless. There may well be cases where this test can provide important information to aid a patient’s decisions regarding treatment and follow-up. However, facts and words matter. As melanoma patients, our lives are on the line. We deserve to have this forum as a place free of adverts and corporate double speak. If this test is FDA approved, please let us know where that is documented.
Furthermore, perhaps I am alone in this – but I am not interested in the views of corporate representatives. For instance ~ I believe in Opdivo. I was in a phase 1 trial back when it was known as MDX1106 and then BMS936558. I am certain it saved my life. Since then, nivolumab, brand name Opdivo, alone and in combination with other therapies including ipilimumab/Yervoy has revolutionized melanoma treatment. Still, I am not interested in what corporate reps from Bristol Myers Squibb have to say about it. I want to know what researchers, oncologists, patients and their families can tell me.
Again, maybe that’s just me. Still, melanoma patients deserve a place that is free from folks with an underlying desire to sell their products – no matter how worthy (or not) they may be. Any clarification on this issue would be most appreciated.
Here is a link to the “Ask an expert” video on GEP testing by Castle Biosciences for those interested in information being presented by MRF on the topic of Gene Expression Profile test. I am not sure that this MRF series is giving the full picture and view of main stream melanoma experts about this new type of test that can be using during the melanoma staging process. https://www.youtube.com/watch?v=xjBY_ktlAng
- April 23, 2021 at 11:26 am
ThreefittyParticipant“…melanoma patients deserve a place that is free from folks with an underlying desire to sell their products – no matter how worthy (or not) they may be.”
- April 23, 2021 at 12:37 pm
I’m surprised there is not more concern from the org itself about maintaining perceptions of integrity.
Every junk or commercial post dilutes the overall quality that some have labored for years to build up on this board.
As one who benefits from quality participation, I find commercial come-on’s diminishing to the board and completely unacceptable.
- April 27, 2021 at 10:10 am
First, thank you to all for your comments and concerns regarding the gene expression testing series.
The MRF’s education program fields many questions about the testing and treatment pipeline which is why we engage with leaders in the field to offer more information that may be helpful to melanoma patients and caregivers evaluating their options. This is especially important when it comes to rare melanoma subtypes like OM, as the limited number of FDA-approved treatments puts a greater focus on tests and therapies currently in development in the emerging field of personalized medicine. As noted in the presentations, the series was/is for educational purposes only and any medical questions should be directed to your healthcare professional for discussion.
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