About Age Limit for NIPT

Changing Conditions for NIPT

When undergoing Non-Invasive Prenatal Testing (NIPT), it is strongly recommended to have the test performed at an NIPT-authorized facility.

There are 92 authorized NIPT facilities (as of July 13, 2018), but many facilities that are not authorized also claim to offer NIPT, and in reality, many pregnant women undergo testing at these unauthorized facilities.

Reference: Committee for "Genetics, Health, and Society"

There are concerns about whether pregnant women can undergo NIPT (Non-Invasive Prenatal Testing) safely and securely, make decisions with their partners based on the results, and receive comprehensive support, including subsequent counseling.

In response, some authorized facilities have modified certain conditions.

One of the conditions for undergoing NIPT was being "35 years or older," which previously defined older pregnant women based on their age at the expected delivery date.

However, it has now been announced that rather than solely determining eligibility for the test based on being 35 or older, the decision will be made on an individual basis through "individual consultations" to cater to each pregnant woman's needs.

This raises the question of why the age threshold of 35 years for older pregnant women is being changed now.

The previous conditions for pregnant women wishing to undergo NIPT were as follows:

• Those whose fetal ultrasound suggests a possible chromosomal abnormality in the fetus
• Those whose maternal serum marker tests indicate a possible chromosomal abnormality in the fetus
• Those who have previously been pregnant with a child having a chromosomal abnormality.
• Older pregnant women
• Those where either parent has balanced Robertsonian translocation, posing a risk of trisomy 13 or trisomy 21 in the fetus

Reference: Public Interest Incorporated Association Japan Society of Obstetrics and Gynecology Ethics Committee

Among the conditions mentioned above is "older pregnant women," which is currently defined as 35 years old.

However, before 1991, this was defined at a younger age of 30 years old.

Reference: Increasing Maternal Age at Childbirth: Current Situation and Issues

Although the definition above pertains to first-time pregnancies, what does the relaxation of the significant age condition for undergoing NIPT mean?

Limitations of NIPT Authorized Facilities

Due to the trend of later marriages and the increasing age of first-time mothers, more pregnant women are inevitably experiencing anxiety about pregnancy and childbirth.

Issues associated with advanced maternal age include difficulty conceiving, a higher rate of miscarriage, and an increased risk of chromosomal abnormalities.

As a result, more pregnant women are undergoing NIPT. However, there are still not enough facilities accredited by the Japan Society of Obstetrics and Gynecology to meet the demand, leading to a shortage of supply for pregnant women.

This is evidenced by the continuous number of pregnant women seeking tests at unaccredited facilities.

In some cases, disciplinary actions have been taken against obstetricians and gynecologists at these unaccredited facilities for conducting NIPT. Despite this, the number of pregnant women undergoing NIPT at non-accredited facilities continues to rise.

The guidelines on NIPT also state that "the current NIPT is exceeding its limits," indicating that the needs of pregnant women wishing to undergo NIPT are not being met. Additionally, the academic society has publicly acknowledged that the supply is not keeping up with demand.

Reference: Public Interest Incorporated Association Japan Society of Obstetrics and Gynecology Ethics Committee: Guidelines on Non-Invasive Prenatal Testing (NIPT) Using Maternal Blood

Despite knowing that undergoing tests at accredited facilities provides greater reliability and appropriate counseling, many pregnant women still opt for tests at unaccredited facilities.

For example, the following reasons can be considered:

• Variations in the availability of NIPT-accredited facilities depending on the region
• Attraction to exaggerated advertisements from unaccredited facilities
• Unaccredited facilities often have no age restrictions, and some pregnant women may not fully understand the significance of NIPT

First, there is a disparity in the distribution of NIPT-accredited facilities, with significant regional differences, especially in rural areas.

As a result, pregnant women may visit unaccredited facilities because they are closer or due to being drawn in by exaggerated advertisements.

In this context, the "conditions for accredited facilities" have become a topic of debate.

Conditions for Undergoing NIPT, Will They Be Relaxed?

According to the guidelines on NIPT by the Ethics Committee of the Japan Society of Obstetrics and Gynecology, the conditions for NIPT-accredited facilities are as follows:

• The facility must have obstetricians and pediatricians with sufficient knowledge and clinical experience in prenatal diagnosis (particularly numerical abnormalities of chromosomes 13, 18, and 21) working there at all times
• It is desirable for the facility to have certified genetic counselors or genetic nursing specialists besides the physicians
• At least one of the above obstetricians or pediatricians should hold a qualification as a clinical genetic specialist
• The facility should have an established department specializing in genetics, where the above-mentioned physicians, counselors, and nurses collaborate in providing medical care

Additionally, the facility should be equipped to provide comprehensive counseling and have a system in place for close cooperation with affiliated facilities.

The number of obstetricians and facilities nationwide is decreasing each year, and there are still very few facilities that meet all these stringent requirements for performing NIPT.

Reference: Obstetric and Gynecological Medical System and Work Environment: Based on Facility Information Survey 2018

Therefore, it is believed that the condition regarding the age of pregnant women was relaxed to widen the scope and prevent pregnant women from turning to unaccredited facilities as much as possible.

While the conditions for pregnant women to undergo NIPT have been mentioned previously, the age condition is among the five criteria and has the lowest threshold for relaxation.

It is expected that not only the NIPT-accredited facilities that have already changed this condition but also other facilities will follow suit in the future.

Although the risk of the NIPT procedure itself is very low for pregnant women, the results can have lifelong implications for the pregnant woman, her family, and the fetus.

Therefore, it is essential to undergo the test at a facility where appropriate counseling is available and comprehensive support is provided to ensure a regret-free decision.

It is hoped that the number of NIPT-accredited facilities will continue to increase. Additionally, like the recent change in the conditions for pregnant women eligible for NIPT, further relaxation of conditions is likely to enable more pregnant women to undergo the test with peace of mind.

Even in the facilities where the conditions have changed, it is not strictly defined as "eligible for testing from a certain age," but rather handled on a case-by-case basis through individual consultation.

If you, your partner, or your family have any concerns, start by understanding NIPT. Then, ensure that you receive comprehensive support to make the appropriate decision without regret, regardless of the test results.