Community› The Bump Message Boards› Pregnant after 35
Pregnant after 35
New Discussion
Options

Harmony Test / MaterniT21 Test

xhea1125xhea1125 member
in Pregnant after 35
Does anyone know a doctor in Chicago that will let their patient take this test?  My dr doesn't want me to do the test because it has yet been approved by the FDA..... 
Report Reply to Post

Re: Harmony Test / MaterniT21 Test

  • Options
    AdiAdi
    Since when do lab tests need to be approved by the Food and Drug Administration?! It doesn't sound like  the FDA has any "jurisdiction" over them. It's not a medication.
    Report Reply
  • Options
    buggirl72buggirl72 member

    imagexhea1125:
    Does anyone know a doctor in Chicago that will let their patient take this test?  My dr doesn't want me to do the test because it has yet been approved by the FDA..... 

    Interesting. They have finished clinical trials and are perfectly safe and highly accurate.  I have no idea who does the Harmony test in the Chicago area but I would start calling Maternal and Fetal Centers. I would also ask your doctor to give you a referral to a place that does them. If all else fails, you could try to get in touch with the companies that distribute the tests and see if they can put you in touch with a facility that does them.


    The day the Bump died - Jasper is wise
    Image and video hosting by TinyPic
    Report Reply
  • Loading the player...
  • Options
    xhea1125xhea1125 member

    I thought it was very odd too since I've read a lot of people having these tests on the boards.   

    It does say on their website that it has not been approved, so I guess they are not going to risk their license on it..  So now I'm scrambling to find someone/somewhere that does the test.. =( 

    Report Reply
  • Options
    Mrs.PawsMrs.Paws member

    Screening tests, which is how MaterniT21 is marketed, do not need to be approved by the FDA.  However, diagnostic tests do.  The difference is important in how to read the results.  Screening tests are offered when someone is high risk or suspected of having something.  It helps determine whether a diagnostic test is needed.

    My doctor is offering MaterniT21 and still doing NT Scans.  If either shows an increased likelihood of something, she'll said we can talk about getting a CVS.  

    If MateniT21 ever gets FDA approval that will likely mean it has its accuracy rate up to 99.8 or so, which is where CVS and amnio typically are.  In other words, it'll replace those tests.

     

     

    Report Reply
  • Options
    ReeceFamilyReeceFamily member
    Hmmm.  I go to a huge University of California medical center and they offer Harmony.  I don't think they'd offer it if it weren't considered safe/valid. Hope you find a provider in your area, we were really happy with it!
    Baby Birthday Ticker Ticker
    image
    Report Reply
  • Options
    l01bl01b member

    I am with MFM @ Loyola and they do it.  I didn't have it because my First trimester screen looked really good, but am positive they offer it.

     

    Hope that helps. 

    Report Reply
  • Options
    StaceySMC13StaceySMC13
    I'd also suggest genetic doctors.  I went to one for my NT Scan and they were really excited about the MaterniT21 Test.  Not sure if it would be beneficial but you also could call the lab in California and ask what to do since your doc won't give you the test.  The lab is called Sequenom.  
    ~ Single Mother by Choice ~ IUI with donor sperm - BFP on 2nd attempt! BabyFruit Ticker
    Report Reply
  • Options
    KatieM558KatieM558 member
    Chicago women's health group gives them. Associated with Northwestern. 
    Image and video hosting by TinyPic
    Report Reply
  • Options
    ElocinElocin member
    I just had my first real OB appointment today, and my Drs office is offering MaterniT21. However, it's a very new test and you should check woth your insurance carrier before you get your blood drawn. The DNA testing is thousands and thousands of dollars and if you're insuarnce doesn't cover it, it could be ton of OOP expense for you. I'm still scheduling my NT scan and will get my second tri quad bloodwork done as well, but I'm also calling my insurance carrier to see if they'll cover MaterniT21 and if they do, if they will still do the 2nd tri quad.
    BFP #2 5/31/12 CP 5w2d 6/4/12 BFP #3 7/9/12 EDD 3/8/13 Another Girl!! Lilypie Pregnancy tickersBaby Birthday Ticker Ticker
    Report Reply
  • Options
    dukemelidukemeli member

    imageElocin:
    I just had my first real OB appointment today, and my Drs office is offering MaterniT21. However, it's a very new test and you should check woth your insurance carrier before you get your blood drawn. The DNA testing is thousands and thousands of dollars and if you're insuarnce doesn't cover it, it could be ton of OOP expense for you. I'm still scheduling my NT scan and will get my second tri quad bloodwork done as well, but I'm also calling my insurance carrier to see if they'll cover MaterniT21 and if they do, if they will still do the 2nd tri quad.

    This is not the case. The lab requires you to pay $235.00 up front and will submit to your insurance after the test is performed. If your insurance denies the claim Sequenom (the lab that performs the test) will not come back to you for the difference. I know this from first hand experience has I had the test performed at 16 weeks.

    Baby Birthday Ticker Ticker Lilypie Pregnancy tickers
    Report Reply
This discussion has been closed.
Choose Another Board
Search Boards
"
"