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ColumnPostponement of the Expansion of Authorized NIPT Facilities: What Should We Do Next?

Postponement of the Expansion of Authorized NIPT Facilities: What Should We Do Next?

Postponement of the Expansion of Authorized NIPT Facilities: What Should We Do Next?

In June 2019, the Japan Society of Obstetrics and Gynecology issued guidelines for the expansion of new prenatal testing (NIPT).
This article explains the postponement of the expansion of facilities that can conduct NIPT, the reasons behind it, and how pregnant women, as the recipients of these tests, should respond going forward.

Table of Contents

What Are the New Guidelines for NIPT?

In June 2019, the Japan Society of Obstetrics and Gynecology issued new guidelines on "Non-Invasive Prenatal Testing (NIPT) using Maternal Blood." These new guidelines consider that pregnant women who need to undergo the test can receive appropriate tests fairly and without anxiety. Previously, testing at approved facilities was recommended, but the new guidelines expand the scope to include core hospitals and affiliated hospitals. Facilities with obstetricians and gynecologists trained in prenatal diagnosis can also offer NIPT testing.

Why Were the New Guidelines Issued?

So, why were the new guidelines issued at that time? The background includes an increase in the number of pregnant women undergoing the test and the expansion of testing beyond approved facilities. In 2013, non-invasive prenatal testing began in Japan, and the number of approved facilities increased from 15 to 92 as of July 2018. Since the start of the testing, a system where pregnant women can receive it with peace of mind has gradually been established, and necessary prenatal counseling is provided along with the test. It has been reported that, over four years until the end of fiscal year 2016, a total of 52,490 pregnant women received prenatal counseling, and among them, 48,643 underwent NIPT. Recently, it is not uncommon for pregnant women to undergo testing at medical institutions other than approved facilities. In this context, the increase in older pregnant women, the difficulty for pregnant women needing the test to access approved facilities due to geographical issues, and the greater demand for sufficient prenatal counseling were all problems leading to the issuance of the new guidelines.

What Are the New Guidelines?

The new guidelines from the Japan Society of Obstetrics and Gynecology place greater emphasis on the necessity of prenatal counseling and the importance of a support system to assist in decision-making for pregnant women and their families undergoing non-invasive prenatal testing. The guidelines maintain the stance that testing should not be conducted as a "mass screening for an unspecified number of pregnant women," but rather should be carefully carried out by thoroughly assessing the various individual circumstances. At the same time, the guidelines express concern about the increasing anxiety among older pregnant women and the difficulties in accessing testing due to the limited number of approved facilities, which can be "undesirable" for pregnant women depending on their living area or work situation.

Development of Core and Affiliated Facilities That Meet Requirements

The new guidelines aim to expand the number of facilities where testing can be conducted by allowing it to be done at "core facilities" and their "affiliated facilities" that meet certain requirements. Additionally, the guidelines stipulate that post-test prenatal counseling, subsequent tests and monitoring, and decisions and procedures regarding pregnancy termination should be conducted at core facilities. However, if it is difficult for pregnant women to commute to core facilities due to their residential area, the guidelines provide flexibility by allowing prenatal counseling related to the interpretation of test results to be conducted at affiliated facilities. The conditions for becoming core or affiliated facilities include having obstetricians, pediatricians, genetic counselors, and genetic nurse specialists with extensive knowledge and clinical experience in prenatal diagnosis.

The anticipated benefit of the new guidelines is that pregnant women will find it easier to access prenatal diagnostic tests. The increase in the number of facilities where tests can be conducted means that even pregnant women living in areas without approved facilities will have better access to testing. However, there is also concern that easier access to testing may lead to an increase in the number of pregnant women choosing to terminate their pregnancies based on the test results.

What Do Pregnant Women Think About the Revised Plan for NIPT Facilities?

Various opinions have been expressed regarding the new guidelines. In March 2019, the Japan Society of Obstetrics and Gynecology conducted a web survey among "Baby App" users, with 6,859 responses. Many positive responses were received regarding NIPT and the proposed revisions to the guidelines. Nearly 90% of respondents were positive about the implementation of NIPT in Japan, and about 80% indicated that they would like to consult with a specialist in obstetrics and gynecology when undergoing the test. Additionally, more than 80% of respondents were positive about increasing the number of facilities that can conduct NIPT, and about 70% supported the proposed revisions by the Japan Society of Obstetrics and Gynecology, with only 5% opposing the revisions.

Implementation of the New Guidelines Postponed

Despite the many positive opinions from pregnant women about the new guidelines, their implementation was put on hold due to requests from the Ministry of Health, Labour and Welfare's Maternal and Child Health Division and the lack of agreement from other related academic societies. Moving forward, discussions held by the Ministry of Health, Labour and Welfare will be closely watched. Until the new guidelines come into effect, it is recommended to continue conducting tests according to the previous guidelines.

What Is the Future Direction of NIPT Guidelines?

While the new guidelines would expand the number of facilities where tests can be conducted, making it easier for pregnant women to access testing, there were concerns from other academic societies about the possibility of inadequate prenatal counseling and other issues. To prevent confusion and anxiety among pregnant women, the government decided to address these issues first. Although the future of the new guidelines is uncertain, it remains important to maintain the current testing system according to the existing guidelines. At the same time, it is crucial to establish a system that ensures equal access to testing for all pregnant women who truly need it, along with adequate support and a well-prepared environment.

What Should Pregnant Women Do About NIPT?

Given the uncertainty about when the new guidelines will be implemented, it is generally advisable for pregnant women to follow the existing guidelines for testing. As highlighted in the new guidelines, it remains crucial to receive thorough explanations before and after the test and to undergo prenatal counseling when necessary. Pregnant women should understand why they need NIPT, and couples should discuss and comprehend the implications of the test results before undergoing the procedure. Additionally, if the test result is positive, it is essential to learn about fetal treatment options, the future of children with disabilities, and the support systems available in society.

However, there are limits to what couples can research and understand on their own. Therefore, it is important to consider undergoing testing in facilities that provide a well-established environment for obtaining accurate information both before and after the test. Whether testing is done at approved or other facilities, it is necessary for all pregnant women to have a thorough understanding of the significance of the test and its results and to receive appropriate prenatal counseling. The postponement of the implementation of the new guidelines serves as a reminder of the importance of these preparations and considerations for pregnant women.

Summary

Women who wish to become pregnant in the future need to pay close attention to the national trends and guidelines related to NIPT testing. If the new guidelines are implemented in the future, it is expected that the circumstances for undergoing testing will change significantly. Whether following the existing guidelines or the new ones, it is essential to prioritize ensuring that pregnant women can undergo testing in a safe and secure manner.

References