TOKYO -- The health ministry is set to establish a study panel on noninvasive prenatal genetic testing (NIPT), in which possible chromosome abnormalities in fetuses can be detected from the blood of their mothers.
The move comes as a draft of new guidelines drawn up by the Japan Society of Obstetrics and Gynecology (JSOG) to increase the scope of medical institutions that can conduct such tests has been met with stiff opposition from other medical societies. In the meantime, the number of institutions that do not abide by the society's current guidelines for commercial purposes has been growing rapidly.
This will be the first time in 20 years for the national government to consider regulating prenatal diagnosis.
The JSOG had planned to adopt the new guidelines at a board meeting on June 22, but is set to postpone approval because the Health, Labor and Welfare Ministry advised the society to respond to the matter in line with discussions underway at the central government.
The requirements that medical institutions must meet in order to conduct NIPT will be among the topics of discussion at a study panel to be launched by the health ministry as early as this summer.
With NIPT, a maternal blood test can determine whether there is a possibility a fetus has one of three diseases, including Down syndrome. This has raised concerns, however, that expecting mothers may abort their fetuses if they believe there is a possibility their child has one of these diseases. Critics have warned that such prenatal diagnosis could lead to selection of who should live.
In 2013, five academic organizations -- including the JSOG, the Japanese Association of Medical Sciences and the Japan Society for Human Genetics (JSHG) -- approved guidelines stipulating that medical institutions must meet strict conditions to receive permission to conduct NIPT. Under the guidelines, NIPT began at selected institutions as clinical research.
In the spring of 2018, NIPT was upgraded to a general medical practice. Currently 92 medical institutions are authorized to conduct this type of prenatal diagnosis. Over the 5 1/2-year period until September last year, more than 65,000 cases of such testing were conducted across Japan.
However, a rapidly growing number of medical institutions are conducting NIPT without permission. Although medical institutions can conduct NIPT to see if fetuses have one of the three specified illnesses under the current guidelines, many institutions advertise that they can examine whether fetuses have other kinds of chromosome abnormalities to attract patients.
In a bid to decrease such unauthorized practices, the JSOG unveiled a draft of new guidelines in March, which would ease requirements for medical institutions to conduct NIPT so that smaller institutions could receive permission to perform such testing. The drafted guidelines would simplify the genetic counseling procedure by experts, enabling obstetricians and gynecologists alone to provide such counseling.
However, the JSHG, the Japan Pediatric Society and other organizations have bitterly criticized the proposal.
In the 1990s, the rapid spread of another type of blood test known as maternal serum screening (MMS), which similarly detects the possibility of a fetus's chromosome abnormalities from the mother's blood, became an issue in Japan. In 1999, a panel of experts under the health ministry put the brakes on the MMS method by issuing a statement saying, "Medical practitioners do not need to proactively notify expecting mothers of test results."
(Japanese original by Norikazu Chiba, Science and Environment News Department)