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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
    Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Twain
    ---------------------------------------------------------------------------------------------------------------------------------------------------
    Surgery 2/10/93 A/P fusion T4-L3
    Surgery 1/20/11 A/P fusion L2-sacrum w/pelvic fixation

  • #2
    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

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    • #3
      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

      Comment


      • #4
        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

        Comment


        • #5
          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.

          Comment


          • #6
            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."

            Comment


            • #7
              The idea of the test also is to guide follow-up care. If a curve has a low risk for progression they would space out the doctor's visits and x-rays to reduce radiation exposure. And of course they are not going to recommend surgery for a kid based on the results irregardless of curve! Only kids with curves large enough for surgery will receive surgery recommendations. The genetic test will just be one more piece of information.
              Gayle, age 50
              Oct 2010 fusion T8-sacrum w/ pelvic fixation
              Feb 2012 lumbar revision for broken rods @ L2-3-4
              Sept 2015 major lumbar A/P revision for broken rods @ L5-S1


              mom of Leah, 15 y/o, Diagnosed '08 with 26* T JIS (age 6)
              2010 VBS Dr Luhmann Shriners St Louis
              2017 curves stable/skeletely mature

              also mom of Torrey, 12 y/o son, 16* T, stable

              Comment


              • #8
                It's too bad that they're only testing on girls, and at age 9. I would think most parents who would be interested in having it done would be those who have a family history, in which case it can start much younger than that.
                Emily

                Comment


                • #9
                  Testing? To benefit *whom*, really?

                  I've been wondering when this would become a huge revelation ... that really isn't.

                  Also would LOVE to hear what weight the SRS doctors place on this. Surely it will be a big topic (or ... not) in San Antonio for the 2009 conference (I am SO not missing this one! ;-).

                  Yes, it's a start ... but I also believe the efficacy (and applicable group of patients) is overrated. Your mileage may vary, as always ... but my JIS curve was ±35° when diagnosed at age 10. Beyond the parameters (even as a female) others have mentioned.

                  And, LMAO they signed with Depuy - and a "small group of physicians in the U.S." will initially be afforded the tools to launch. Makes you wonder where the organizations interests lie.

                  From the press release:

                  "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."


                  9,500 patients from 85 clinical sites throughout the world isn't enough to prove it out? And what OTHER spine diseases when they can't even say it's effective for scoli prediction??

                  Pam
                  Last edited by txmarinemom; 12-28-2008, 08:38 AM.
                  Fusion is NOT the end of the world.
                  AIDS Walk Houston 2008 5K @ 33 days post op!


                  41, dx'd JIS & Boston braced @ 10
                  Pre-op ±53°, Post-op < 20°
                  Fused 2/5/08, T4-L1 ... Darrell S. Hanson, Houston


                  VIEW MY X-RAYS
                  EMAIL ME

                  Comment


                  • #10
                    Well, it would be a great medical breakthrough if it worked.
                    I looked at their website to try to see some information about accuracy/ reliabality. They really dont have too much in their "publications" portion. It looks like a few poster sessions and presentations.
                    I would think a physician would want to see the basis of proof of just how and why this test works. Heck, a parent would want to see the same.
                    Of course, since the test does no harm (unless medical decisions are made based on results) I guess it doesnt hurt to try it.
                    The 13 year old cut off seems random. Does DNA change as you age?

                    I saw two things that were pretty interesting from their website (although not directly related to the DNA test discussion).

                    One of the presentations was given last year at the SRS meeting in Utah. I looked at the program here The talk was only 4 minutes long. Many of the talks were just 4 minutes. Is that usual for these medical conferences?
                    8:30 - 8:34 am Predicting Brace-Resistant Adolescent
                    Paper #6 Idiopathic Scoliosis
                    (I dont suppose anyone here has a copy of the proceedings)
                    It looks like the talks were in rapid fire progression and they finished that day at noon. Perhaps physicians are used to processing information rapidly, but that seemed odd to me.

                    the other thing I was amused to see was from the axialbiotech website where they were talking about how great it was to do DNA work in Utah. They said:
                    Known Paternity: Fewer errors occur when studying extended families in Utah because the incidence of “non-paternity” (unknown or incorrectly attributed fathers) is lower. (<1% among Utah residents verses approximately 10% for the rest of the U.S. )

                    10%? wow.

                    Maybe I should get off the computer and spend more time with my dear wife.

                    Comment


                    • #11
                      Originally posted by concerned dad View Post
                      the other thing I was amused to see was from the axialbiotech website where they were talking about how great it was to do DNA work in Utah. They said:
                      Known Paternity: Fewer errors occur when studying extended families in Utah because the incidence of “non-paternity” (unknown or incorrectly attributed fathers) is lower. (<1% among Utah residents verses approximately 10% for the rest of the U.S. )

                      10%? wow.

                      Maybe I should get off the computer and spend more time with my dear wife.
                      That could be explained easily if only about 5 guys fathered most of the kids in the state.
                      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."

                      Comment


                      • #12
                        Originally posted by concerned dad View Post
                        One of the presentations was given last year at the SRS meeting in Utah. I looked at the program here The talk was only 4 minutes long. Many of the talks were just 4 minutes. Is that usual for these medical conferences?
                        I think it's different for every conference. SRS papers are 5 minutes long. They're pretty strict about it.

                        --Linda
                        Never argue with an idiot. They always drag you down to their level, and then they beat you with experience. --Twain
                        ---------------------------------------------------------------------------------------------------------------------------------------------------
                        Surgery 2/10/93 A/P fusion T4-L3
                        Surgery 1/20/11 A/P fusion L2-sacrum w/pelvic fixation

                        Comment


                        • #13
                          Hi,
                          I recently came across this powerpoint presentation posted on the web regarding the genetic testing:


                          http://www.vinzenzgruppe.at/vinzenzg...3Ogilivie.pdf/



                          I do not know much about the accuracy or validity of this presentation - the company who posted it is in Austria I think.........but I thought it might be interesting reading for those following the genetic testing progress.
                          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

                          Comment


                          • #14
                            Thanks for posting that, Cara!

                            Very interesting.

                            I note that their ideal future doesn't include bracing.

                            This is consistent with the literature on the efficacy of bracing in my opinion.

                            (I further note the ideal future doesn't include woo-woo "treatments" but I won't dwell on that.)

                            Evidence-based medicine... more than just a good idea.

                            sharon
                            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."

                            Comment


                            • #15
                              Originally posted by nate03 View Post
                              Hi,
                              I recently came across this powerpoint presentation posted on the web regarding the genetic testing:


                              http://www.vinzenzgruppe.at/vinzenzg...3Ogilivie.pdf/



                              I do not know much about the accuracy or validity of this presentation - the company who posted it is in Austria I think.........but I thought it might be interesting reading for those following the genetic testing progress.


                              Cara, this was authored by the same people in SLC, Utah--James Ogilvie

                              Comment

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