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40 Japanese medical institutions gave unapproved prenatal testing: Mainichi survey


TOKYO -- At least 40 medical institutions have conducted noninvasive prenatal genetic testing (NIPT), in which possible chromosome abnormalities in fetuses can be detected from the blood of their mothers, despite being unauthorized to do so, a survey by the Mainichi Shimbun has found.

The actions by those institutions come in violation of medical society guidelines, which require certain conditions for medical institutions to be authorized to perform such testing.

Of the 40 institutions, approximately 90%, or 37 institutions, have carried out NIPT in divisions other than obstetrics departments or OB-GYN departments, according to the survey. In many of those cases, NIPT has been performed in cosmetic surgery departments. Furthermore, those institutions have not provided sufficient counseling to patients.

The survey targeted 40 institutions in Tokyo, Hokkaido and 13 other prefectures around the country that had advertised NIPT screenings on their websites as of the end of July 2019 or had been known to the Mainichi to be running those tests through earlier news gathering.

When asked if they had carried out NIPT, all of the 40 institutions said they had. However, when the Mainichi asked local public health centers and regional bureaus of health and welfare about which departments the institutions reported as the primary performers of NIPT, it emerged that only three institutions had cited the obstetrics department or OB-GYN department.

Twenty-one institutions had reported that their cosmetic surgery department was responsible for NIPT, forming the largest group, while other institutions had cited the internal medicine or cardiovascular departments.

When the 37 institutions that have conducted NIPT at non-OB-GYN departments were asked if part-time obstetricians were involved in NIPT screenings, 30 of them responded that no obstetricians took part in the testing. The remaining seven institutions did not answer that question.

NIPT has been the subject of controversy as it could lead to abortions on the grounds of abnormalities found with fetuses. The Japan Society of Obstetrics and Gynecology has accordingly set guidelines that require institutions to: have OB-GYN specialists and pediatricians regularly in attendance; provide expert counseling to patients in order for them to understand the purpose of NIPT and the ethical issues entailing it; and limit the conditions subject to NIPT to Down syndrome and two other disorders, among other requirements. The Japanese Association of Medical Sciences then authorizes institutions that meet those requirements as eligible to conduct NIPT.

When the survey asked the 40 institutions whether they provided counseling to patients, 31 of the 32 responding institutions said they either gave no counseling or provided nothing more than explanations about the content of the testing.

With regard to a question over whether they limited the conditions subject to NIPT to the three specific disorders, all of the 31 institutions that responded said they had conducted NIPT for other disorders as well. These institutions included those that perform NIPT at their obstetrics department or OB-GYN department.

Twelve institutions responded to survey questions through companies that mediate between medical institutions and firms that examine samples. Altogether, more than 10,000 NIPT screenings were performed by those 40 institutions.

In addition, outside of those 40 organizations, it is believed that there are multiple doctors who have conducted NIPT without authorization.

(Japanese original by Asako Kamihigashi, Lifestyle and Medical News Department, and Norikazu Chiba, Science & Environment News Department)

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