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Japan ob-gyn society considering looser requirements for new prenatal genetic test

A couple is seen in this undated photo. (Mainichi)

TOKYO -- In the wake of unpermitted testing, the Japan Society of Obstetrics and Gynecology has decided to loosen requirements for performing certified noninvasive prenatal testing (NIPT) to increase the number of medical institutions that can appropriately perform the exam, it has been learned.

NIPT can detect if a fetus has any chromosomal abnormalities simply from a blood sample from the mother. It is both more accurate and much less of a burden than tests such as those involving the amniotic fluid, which risk miscarriage or infection. While a confirmation test of the amniotic fluid is needed, NIPT can be administered as early as around 10 weeks of pregnancy. If the results of the test are positive for a disease, however, then there is a high chance that the fetus will not be carried to term, leading to ethics claims of unnatural selection of which children will be born.

The testing was introduced for clinical research by the society in 2013 and limited to selected institutions. Just this March, the society changed their guidelines such that general institutions registered with and certified by the Japan Association of Medical Sciences could also administer testing. With the further loosening of requirements, it looks as though NIPT will begin to spread quickly throughout Japan.

The guidelines for NIPT include having both an obstetrics and gynecology specialist and a pediatrician as regular employees, having at least one of those doctors being qualified as a clinical genetic specialist, to have an outpatient department specializing in genetics and other requirements, such as women being tested being older or having a history of becoming pregnant with a child with chromosomal abnormalities. These prerequisites have not changed since the testing was shifted from clinical research to a general diagnostic.

But the response to these guidelines has been that they are too strict, and some institutions have begun administering the test without getting approval from the medical association. If an abnormality is found, the parents must make a very difficult decision, and the lack of proper counseling and examination of other chromosomal abnormalities besides the targets Down syndrome (Trisomy 21), Trisomy 18 (Edward's syndrome) and Trisomy 13 (Patau syndrome) have become a problem.

Ahead of its June directors meeting, the Japan Society of Obstetrics and Gynecology has created a special committee to examine the guidelines for NIPT. Experts at the Japan Pediatric Society, the Japan Society of Human Genetics and other organizations are also engaging in the debate, and are considering not having their members work with institutions that have not received proper certification for the testing.

A new certification for obstetricians and others involved in prenatal care in genetic counseling is also being considered to combat the limited availability of proper counseling from clinical genetic experts. There is also deliberation as to if the age of the mother should be a factor and other conditions, bringing up the possibility for a complete overhaul of the current rules for NIPT.

(Japanese original by Norikazu Chiba, Science & Environmental News Department)

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