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  1. #1
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    The Axial Biotech Test is Here

    SALT LAKE CITY, Dec. 9 /PRNewswire/ -- Axial Biotech, Inc. announced today the commercial launch of a new DNA-based test that indicates the likelihood of progression to a severe curve for children diagnosed with Adolescent Idiopathic Scoliosis (AIS). This new molecular diagnostic tool marks a major advancement in which medical treatments can be personalized to patients diagnosed with this deforming disease. The test will be marketed under the name of ScoliScore(TM) AIS Prognostic Test.


    Scoliosis is an abnormal curvature of the spine that affects two to three percent of the population, or an estimated 7 million people in the United States. Most often scoliosis is identified during school or sport screenings. Girls are eight times more likely than boys to have a curve progress to a point that treatment is required.


    Currently, to determine whether or not a curve will progress patients are observed over a period of several years with the uncertainty of not knowing what the long-term outcome is likely to be. If the curve does continue to progress, the most widely accepted treatments are spinal bracing or ultimately spinal fusion surgery.


    "For decades, spine surgeons have been looking for ways to determine which patients may progress and which may not," stated Ken Ward, M.D., Chief Scientific Officer for Axial Biotech. "Currently, most patients diagnosed with scoliosis have spinal x-rays repeated over several years because of the lack of precise clinical indicators or markers that can identify the likelihood of severe curve progression. This lack of predictive information is very inefficient and can cause adolescents to be given years of unnecessary radiation exposure."


    ScoliScore(TM) was developed by utilizing a genome wide association study that identified a panel of 53 genetic markers associated with severe curve progression. This scoliosis research involved collecting DNA samples from over 9,500 patients from 85 clinical sites throughout the world. The test was then further validated in two separate clinical trials.


    John Climaco, CEO and President of Axial Biotech, said that the launch of ScoliScore(TM) illustrates the company's commitment to making critical information from molecular diagnostic tests more broadly available to spinal surgeons, patients, and their family members. "Our long-term vision is to utilize the knowledge and capabilities gained from the development of this test and apply it to other spinal diseases," said Mr. Climaco.


    The initial launch of the ScoliScore(TM) test will be to a small group of physicians in the U.S. The test will be processed solely at Axial's CLIA certified laboratory, which meets all applicable state and federal guidelines. It will be made commercially available to physicians nationwide in 2009. Axial Biotech has signed an agreement with DePuy Spine, Inc. to sell and market ScoliScore(TM).


    For more information on the ScoliScore(TM) test, please contact Axial Biotech Customer Service at 877-AXIAL98 (877-294-2598) or visit the company's website at www.axialbiotech.com

  2. #2
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    May 2005
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    Thanks for posting Linda, I was wondering when it would start being put to use. Our ortho dr. said he was going to start utilizing this test soon and I am eagerly anticipating this for my 10 yr. old.

    Renee

  3. #3
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    May 2005
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    672
    Well, we saw our dr. this week for my older son's 3 yr. post op checkup and was able to ask about the ScoliScore testing for my 10 y.o. We were told that the testing should begin soon sometime after the first of the year BUT they will initially only be offering the test to girls between 9-13 y.o. with an initial scoliosis diagnosis of 16-25 deg. I'm bummed, my son falls perfectly w/in that range.

    Renee

  4. #4
    Join Date
    Nov 2007
    Posts
    90
    Yes, I just got the same type of disappointing news. My older son, just turned 14 and was diagnosed with a 22 degree curve last week, but he also is not eligible for the test. We were given the possible option of having him participate in the next trial, which we will gladly do to help others..........but it won't benefit him any personally. My daughter has been told she has mild scoli, and she is age 11, so I may try to have her tested. But, it is offered at very few hospitals right now and with it being so narrow I honestly don't know if I would find it very meaningful at this point anyhow.

    At least they are getting a step closer to some answers.........but it definitely has a long way to go!

    -Cara
    Cara, Mom to Nathan
    Diagnosed 24 deg. in July 2007, progressed to 38 deg. by August 2007
    Boston Back Brace 8/07 12/07
    VBS 12/10/07 Boston Children's Hospital
    Dr. Hresko
    40 Degrees before VBS
    11 Degrees now!! (2012)

    Nathan's VBS Video

    www.vertebralstapling.com

  5. #5
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    If this test is accurate, does this mean that they will recommend spinal surgery for any child that qualifies irrespective of the degree of curvature at the time of testing.

  6. #6
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    Quote Originally Posted by Rayknox View Post
    If this test is accurate, does this mean that they will recommend spinal surgery for any child that qualifies irrespective of the degree of curvature at the time of testing.


    I think the main outcomes will be to:

    1. avoid bracing kids who will not progress to surgery territory, and

    2. avoid bracing kids who are going to progress to surgery territory absent some robust evidence bracing works.
    Sharon, mother of identical twin girls with scoliosis

    No island of sanity.

    Question: What do you call alternative medicine that works?
    Answer: Medicine


    "We are all African."

  7. #7
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    SALT LAKE CITY ...? Is the same?? http://www.scoliosis.org/forum/showt...c-Test-for-AIS

  8. #8
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    Mar 2010
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    I believe that is where these researchers are located.
    Be happy!
    We don't know what tomorrow brings,
    but we are alive today!

  9. #9
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    Mar 2010
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    Would be true that about those 3 or 4 men??

  10. #10
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    Mar 2010
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    What 3 or 4 men? I'm sorry I didn't look at the link. Are you referring to the researchers? If so, at least some of them came from the Twin Cities Spine Center in Minneapolis, MN, USA. Dr. Ogillvie for sure.
    Be happy!
    We don't know what tomorrow brings,
    but we are alive today!

  11. #11
    Join Date
    Mar 2010
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    Rorher, I was referring to that

    Quote Originally Posted by Pooka1 View Post
    I think it has been shown that between 3 and 4 men fathered all the children in the Mormon church.
    ...

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