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Ask the Expert today on MRF’s FB Page!

Forums General Melanoma Community Ask the Expert today on MRF’s FB Page!

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      ed williams
      Participant
      Hi there, did I miss something when it comes to the Castle Bioscience test? It hasn’t been approved by the FDA for use in melanoma and it isn’t part of the 8th edition of staging guidelines for use in melanoma at this point or has it been approved and I missed those approvals?

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      ljohnston
      Keymaster
      HI Ed!

      This test has been approved by the FDA for both cutaneous and ocular melanoma to detect gene expressions.

      https://castlebiosciences.com/products/decisiondx-melanoma/

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        ed williams
        Participant
        Interesting, could you then explain this recent article and their recommendations towards GEP testing use in melanoma. https://jamanetwork.com/journals/jamadermatology/article-abstract/2768743?fbclid=IwAR0yNWR8ZXqgufl1Vl49JOooBEILoE8YI5_EuH2cCo7-g62bpAPqiMqn4uI

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        ljohnston
        Keymaster
        Hi Ed-

        I’m not an expert on the test, but its definitely a question that we can pass to their team or you can ask during the Ask the Expert session.  Happy to assist either way!

         

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        ed williams
        Participant
        Hi again MR. Johnston, thanks for your reply to my earlier post. The link you provided is to the company that makes the product. (decision Dx test made by Castle Biosciences). This is not a link to FDA approval for this test and I have tried and failed to find any FDA approvals.

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        Bubbles
        Participant
        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 ipilmumab/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.

        Thank, celeste

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        ThinkingPositive
        Participant
        Cutaneous
        Hi LJohnston,

        I wonder if Castle improved their testing since 2017. At that time, the test said I was at low risk for recurrence (I was at Stage 2A). Insurance did not pay for the test.  Three years later I arrived at metastatic melanoma after I found a lump that popped out in between my every 3 month derm visits; thankfully I am responding to Keytruda now.

        Cindy

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        ljohnston
        Keymaster
        Cindy- I’m so glad that you continued with the appointments and that it was caught!  The test is not 100% accurate, as most tests aren’t unfortunately, I’m sure that the company tries to improve it on a regular basis.  There are many OM patients that were diagnosed class 1 (lowest risk) and then like yourself metastasized.  Based on the information that science has and the markers, that is how the test is used. Unfortunately, every person’s cancer journey is different. I am so glad that you are responding to Keytruda!

         

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      ed williams
      Participant
      Hi Mr. Johnston, you caught my interest so I have done a little more reading and this article from American Academy of Dermatology clinical practices guidelines for cutaneous melanoma. If you go to page 17 SLNB, page 22 and 23 get into GEP test and their recommendations. I did visit the Castle web site like and found the 80% of all Sentinel test are negative to be not accurate, where it is true that 80% of CLND were found to be negative is a more accurate history of melanoma node surgeries. https://www.jaad.org/article/S0190-9622(18)32588-X/pdf

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      ljohnston
      Keymaster
      All-

      Thank you for the threads on this post regarding the ask the expert series related to gene expression testing.

      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 presentation 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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      Bubbles
      Participant
      Hey Lauren,

      Still curious about the comment you posted above:  “This test has been approved by the FDA for both cutaneous and ocular melanoma to detect gene expressions.” 

      Sometimes we are mistaken.  Sometimes we have gained access to new information.  Either way – accuracy matters.  Any clarity you could provide would be helpful.  And YES!  Talking about ones care with our medical providers is essential.  Still, folks come to this board for support and information.  Comments made here make a real difference.

      Thanks, celeste

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      ljohnston
      Keymaster
      Celeste and group-

      My apologies for the mis-information on the FDA approval.  Before posting this today I made sure our team triple checked everything and communicated with our science teams.

      I know this group looks for the correct information and I extend my apologies for any misdirection, especially since we strive to push out the most up to date info on all treatments, trials, etc.

      Again, sincerest apologies.

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        ed williams
        Participant
        Hi Lauren, how do you walk back all the ask an expert presentation which were a big sales pitch. You would think that before you allow a company to run patient information for the last month, and promote the sessions, that your team would know their background. The question I asked you at the start of a previous thread is common knowledge to those of us with melanoma! The session of “ask an expert” yesterday was like listening to a time share sales pitch. Will there be another “ask the expert” session to cover all the misinformation contained in the previous ones sponsored by Castle?

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