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  • bullnbearnhog bullnbearnhog Mar 10, 2013 9:09 PM Flag

    MT21 in Japan starting April....

    Prenatal blood test to detect Down syndrome to begin in April...

    Prenatal blood test to detect Down syndrome to begin in April

    TOKYO (Kyodo) -- A new type of blood test for pregnant women to detect Down syndrome in a fetus is expected to become available in Japan in April, as a set of guidelines for conducting the test were compiled Saturday.

    The Japan Society of Obstetrics and Gynecology decided at a board meeting guidelines for conducting the prenatal test10+件, designed to detect three types of chromosomal abnormalities in fetuses, including Down syndrome.

    By the end of this month, a body of the Japanese Association of Medical Sciences is expected to finish screening of medical institutions to perform the test.

    About 20 medical institutions, such as the National Center for Child Health and Development, Hokkaido University Hospital, Osaka University Hospital and Showa University Hospital, have already obtained approval from their ethical committees.

    The guidelines say that if the test10+件 is used too casually by parents-to-be given its ease, it could lead to unethical distinction of human life based on disabilities.

    The guidelines also say the test should be limited to facilities where adequate counseling is available.

    Among the requirements for these facilities, the guidelines say they should employ full-time obstetricians, gynecologists and pediatricians certified in clinical genetics.

    The guidelines also limit those who can take the test10+件 to women giving birth at an advanced age or who have a history of fetal chromosomal abnormalities in previous pregnancies.

    The obstetrics and gynecology society had been collecting public opinions for its guidelines since it released a draft in December.

    If in doubt it's MT21, read my prior posts!

    Sentiment: Strong Buy

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    • Impressive. If only we had a patent! That the courts respected and upheld.

      Sentiment: Strong Buy

    • bull, are both a "scrounge extraordinaire" and a "visionary optimist" (much more than T21!)... never hear it enough (at least not on this board)...but THANKS for paying attention and sharing...

      Sentiment: Hold

    • So how are they delivering this? We have no idea. No transparency

    • MORE...

      New prenatal diagnosis may start next month

      The Yomiuri Shimbun

      A new method of prenatal diagnosis that can reveal chromosomal abnormalities in a fetus merely through an analysis of the mother's blood may be adopted as early as next month at a limited number of institutions, the Japan Society of Obstetrics and Gynecology has said.

      Institutions authorized by the Japanese Association of Medical Sciences to utilize the new method must meet certain requirements, and all cases should be treated as clinical trials, according to the guidelines announced Saturday. Applications for authorization can be submitted beginning this week.

      The new test examines fetuses' DNA using a sample of their mothers' blood. Unlike the standard amniotic fluid check, in which a needle must be injected into a pregnant woman's belly, there is no chance it will cause a miscarriage.

      The new prenatal diagnosis method is also more accurate than maternal serum screenings in determining whether fetuses have chromosomal abnormalities. The serum test, also a blood test, can only give the probability of such problems occurring. If results from the latest method are negative, meaning the fetus shows no signs of chromosomal abnormalities, the chance of the fetus being born without such abnormalities is greater than 99 percent.

      However, if the test turns out positive, the rate of accuracy can differ considerably depending on the age of the mother, and therefore an amniotic fluid check is required to identify chromosomal abnormalities.

      The Japan Society of Obstetrics and Gynecology announced the latest guidelines at a press conference in Tokyo along with the Japanese Association of Medical Sciences, the Japan Society for Human Genetics and other related parties.

      The organizations issued a joint statement calling for careful introduction of the new method, acknowledging concerns it could promote "embryo screening."

      According to the guidelines, institutions wishing to become authorized to carry out the new prenatal diagnosis test should meet prerequisites such as:

      -- Having full-time obstetricians and pediatricians on staff.

      -- Ensuring at least a few of such doctors also specialize in genetics.

      -- Having an outpatient genetics department.

      -- Having the ability to provide pregnant women with extensive information and genetic counseling.

      Furthermore, the guidelines say the new method should only be used on women who:

      -- Are carrying fetuses that may have chromosomal abnormalities, as indicated by ultrasound and other examinations.

      -- Have previously become pregnant with babies showing such abnormalities.

      -- Are pregnant relatively late in life.

      Regarding the last point, the guidelines do not mention a specific age, although a draft version announced in December said women aged 35 or older were eligible for the new test.

      The Japanese Association of Medical Sciences set up a task force Saturday to screen, authorize and register institutions that meet the prescribed conditions for implementing the new prenatal diagnostic method.

      The task force consists of officials from three medical organizations--the Japan Society of Obstetrics and Gynecology, the Japan Pediatric Society and the Japan Society for Human Genetics--along with experts on ethics and the law.

      (Mar. 11, 2013)

      Sentiment: Strong Buy

    • Bull-- thanks for that post. HH mentioned ( almost glossed over) the new international agreements coming. He really under-played that aspect. SQNM is the World-Wide leader in NIPT for T21!

      Sentiment: Strong Buy

    • If you're still not sure...

      Japan readies guidelines for Sequenom prenatal Down syndrome Dx

      A new prenatal diagnostic blood test that would help identify fetuses with Down syndrome could launch in Japan this month, now that a major medical society has issued a stringent set of guidelines meant to prevent misuse.

      Japan Times reports on the new guidelines, which the Japan Society of Obstetrics and Gynecology issued in draft form in December and expects to formally sign off on this month. They have in mind the highly scrutinized MaterniT21 Plus test developed by U.S.-based Sequenom ($SQNM), which as the article notes, has a 99.1% accuracy rate of detecting trisomy 21 mutations; Down syndrome patients have three #21 chromosomes instead of two.

      JSOG draft guidelines would limit using the blood test to pregnant women ages 35 and older. The test would also be restricted to women who have previously had children with chromosomal abnormalities, and women who have already been diagnosed in earlier prenatal exams as at risk of having trisomy 21- mutation babies, according to the story. Additionally, hospitals in Japan that offer the test would ideally have full-time doctors with expertise in prenatal diagnosis. JSOG recommendations also call for a certified genetic counselor on staff who would work with pregnant mothers-to-be before and after the diagnostic test.

      Sentiment: Strong Buy

      • 2 Replies to bullnbearnhog
      • Must say Bull, you're on top of/all over it!!! Just read an article from the Japan Times, dtd Jun 17, 2010, titled: "Don’t be afraid to ask questions about giving birth in Japan", which states that in 2009, 22.5 percent of the women who gave birth to Japan’s 1.07 million babies were 35 or over. Point being, that's over 200k in their high risk market. If SQNM can just garner at least half of that or 100k tests, it would increase revenues of over 100 million, unless, of course, SQNM will be giving those tests away (also) for a loss as "Longsqnm" portends. LOL!

        The ribbon cutting of that double-secret Torrey Pines lab may be happening sooner rather than later.
        TX, regards, Bud

        PS SQNM-- T21--and more--and more (right?)!!!

        Sentiment: Strong Buy

      • Thanks! great news

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