Ask the Expert today on MRF’s FB Page!

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

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.

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

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

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?