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Thread: Dante WGS and Promethease?

  1. #11
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    Quote Originally Posted by Donwulff View Post
    I shouldn't really comment, but FDA has implied very heavily between the lines that pharmacogenetic reports are allowed, as long as they do not mention (American) brand-name drugs.
    So reporting about acetylsalicylic acid would be fine, as long as they don't mention Aspirin? I thought that was what Promethease was doing anyway?


    Yes the disclaimers in the report and in the ToS are thorough, but I think this whole notion of "it's research with error bars, not facts and health advice" needs to be featured directly on the product page. Right now, they advertise:
    Report on 100+ common diseases, common hereditary cancers, 30+ wellness and longevity traits
    To me, they are implying that you get screening for hereditary cancers with yes/no answers, and that is specifically what the FDA wants to (and should) regulate and mandate minimum standards of sensitivity/specificity for.
    It's very rare that companies get away with selling you X while putting (well actually, not really X) into page 27 of their terms of service.

  2. #12
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    Sex

    I'm not a lawyer, so of course this is mostly personal interpretation. On the main page at https://www.fda.gov/medical-devices/...ecific#actions FDA says, "Most firms addressed the FDA’s concerns by removing specific medication names from their labeling, including promotional material and patient test reports." Feel free to interpret "specific medication names" how you will. It's important to note though that there's a difference between what is decreed and prohibited, and what's enforced. FDA puts it just a few lines above as [FDA] "will take compliance actions when appropriate, such as when the tests pose significant public health concerns."

    And yes, you can still go on SNPedia and enter https://www.snpedia.com/index.php/Aspirin for example, they've just removed the pharmacogenetic section from the reports. They're still violating every other category of the FDA genetic tests charter, IFF research platforms/literature-retrieval systems are covered. It's a bit tricky for Promethease though, because of course they like to sell it as a complete & best consumer solution. I understand the argument that FDA's policies are unfair and stifle innovation, though in reality they hold Promethease's competition back lot more than them. (Well okay MyHeritage doesn't seem to care about that).

    I have reservations about Dante Labs marketing and legal strategy, but that doesn't currently affect the product, nor is it my problem. However, I think the non-existent/fine-print disclaimers, especially on marketing materials, are much more common choice right now. Obviously they shouldn't be. On the other hand, on social media for example everybody(that's expressing an opinion for some reason) is pushing Promethease as a completely unerring, perfect analysis. There's active hate if someone says it's derived from publicly editable Wiki, contains errors, and shouldn't be used blindly (Although this does go for essentially every genetic, or biological test out there). Either practically nobody has read the disclaimers, or they choose not to believe them. I think Promethease reports do not contain any disclaimers themselves, and it was impossible to re-read them easily last I checked, so it's believable that the average customer doesn't even notice them.

    But yeah, this too is getting into wider ethical discussions than the topic

  3. The Following User Says Thank You to Donwulff For This Useful Post:

     pmokeefe (06-13-2019)

  4. #13
    deleted

  5. #14
    Quote Originally Posted by Possie View Post
    Well, that did not work out for me unfortunately. Dropbox seems to have an upper filesize limit of 50Gb. My BAM File exceeds this - its 98GB. Did you compress or split your file perhaps ? Or was it under 50GB ?
    * edit * Well, figured it out. upload of 98Gb BAM file from PC to Dropbox in the app sucessfull. My bad - tried uploading it via internet - dumbass. Now i can finally drop the DL link to Promethease.

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