Age Limitations for NIPT

Age Limitations for NIPT

Until now, the condition considered pregnant women whose age on the expected delivery date would be 35 years or older as older pregnant women.
In this article, we will consider what the current situation is and what the future holds in terms of the age and conditions for receiving NIPT.

Changing NIPT requirements

For NIPT (new prenatal diagnosis), testing at a NIPT-approved facility is strongly recommended.

Although there are 92 NIPT-approved facilities (as of July 13, 2008), many unapproved facilities claim to be able to provide NIPT, and many pregnant women are actually undergoing testing at unapproved facilities.

See also: "Genes, Health, and Society" Study Committee

There are concerns about whether pregnant women will be able to undergo NIPT safely and securely, and then receive full support, including counseling afterward, to help couples make decisions based on the results.

In contrast, some of the licensed facilities have changed some of their conditions.

One of the conditions for undergoing NIPT is "35 years of age or older," a condition that until now has regarded pregnant women whose expected delivery date would be 35 years of age or older as older pregnant women.

However, the company has announced that it will not make a decision on testing based solely on the actual age of 35 years or older, but will decide whether to perform NIPT after "individual consultation" regarding age, in order to accommodate each pregnant woman.

What I am wondering here is why the line of 35 years old for older pregnant women was changed now.

The previous conditions for pregnant women who wish to undergo NIPT are as follows

  • Persons whose fetus may have a chromosome number abnormality on fetal ultrasound examination
  • Persons whose fetus may have a numerically abnormal chromosome by maternal serum marker test.
  • Persons who have ever conceived a child with a chromosomal count abnormality
  • Persons of advanced age
  • Persons in whom one of the parents has a balanced Robertson translocation and the fetus is likely to have 13 or 21 trisomies

Reference: Ethics Committee of the Japanese Society of Obstetrics and Gynecology

The term "older person" is also mentioned in the above conditions, but is currently defined as 35 years old.

However, prior to 1991, they were defined as 30 years of age or older, a lower age than they are today.

See also: The Aging of the Childbearing Age: Current Situation and Problems

Although the above is defined in terms of first births, what does it mean that the age requirement, which is still a major condition for receiving NIPT, has been relaxed?

Limitations of NIPT-approved facilities

It must be said that the number of pregnant women who are anxious about pregnancy and delivery is increasing due to the trend toward later marriages and older age of childbirth, including first births.

The problems with older pregnancies are that they are more difficult to conceive, the miscarriage rate increases, and the possibility of chromosomal abnormalities increases.

Therefore, the number of pregnant women undergoing NIPT is increasing, but at present there are still not enough facilities accredited by the Japanese Society of Obstetrics and Gynecology, and the supply is not keeping up with the demand for pregnant women.

This is supported by the fact that there is no end to the number of pregnant women who undergo testing at unlicensed facilities.

Although disciplinary actions have been taken against obstetricians and gynecologists at unaccredited facilities for performing NIPT, there are still many pregnant women who undergo NIPT at unaccredited facilities.

The guidelines for NIPT also state that "NIPT at this stage has exceeded its limits," and that the current situation does not meet the needs of pregnant women who want NIPT, and furthermore, the academic community has publicly stated that the supply is not keeping up with the demand.

Reference: Ethics Committee of the Japan Society of Obstetrics and Gynecology, Guidelines for Prenatal Genetic Testing (NIPT) Using Maternal Blood

The reason why many pregnant women undergo testing at unlicensed facilities even though they know they have more confidence and will receive proper counseling if they undergo testing at a licensed facility.

For example, you may want to

  • Variation in NIPT-approved facilities by region
  • Unlicensed facilities are drawn in by hype
  • Unlicensed facilities do not have age restrictions, etc., and pregnant women do not understand the meaning of NIPT.

First, NIPT-approved facilities are scattered, and regional differences are real in rural areas.

As a result, pregnant women lured by the proximity or by hype visit unlicensed facilities.

In this context, a controversial issue is the "conditions for licensed facilities.

Conditions for undergoing NIPT, will it be eased?

According to the Ethics Committee of the Japanese Society of Obstetrics and Gynecology's Guidelines on NIPT, the conditions for NIPT-approved facilities are as follows.

  • An obstetrician/gynecologist or pediatrician with sufficient knowledge and experience in prenatal diagnosis (especially in cases of numerical chromosome 13, 18, and 21 abnormalities) must be on staff at all times.
  • It is desirable to have a certified genetic counselor or a nurse specialist in genetic nursing other than a physician on staff.
  • At least one of the above-mentioned obstetrician/gynecologist or pediatrician must be a licensed clinical genetic specialist.
  • A genetic specialist should be in charge of the request, and the above-mentioned physicians and counselors/nurses should cooperate with each other.

In addition to the above, the applicant must have a system in place to provide further counseling and to work closely with cooperating facilities.

The number of obstetricians and gynecologists in Japan and the number of facilities is decreasing every year, and if we look at the facilities that perform NIPT, we can say that there are still very few facilities that meet these requirements.

See also: Obstetrics and gynecology healthcare system and working environment - from Facility Information Survey 2018.

Therefore, it is thought that the age requirement for pregnant women was relaxed in order to widen the market to deter pregnant women who might otherwise have drifted to unlicensed facilities.

The conditions for pregnant women who are eligible for the NIPT test have been mentioned above, but of the five conditions, age is the one with the lowest hurdle for relaxation.

In addition to the NIPT-approved facilities that have changed their conditions, we suspect that similar changes will be made at other facilities in the future.

Although the risk of the test itself to the pregnant woman is very low, the results of NIPT can affect the life of the pregnant woman, her family, and the fetus.

Therefore, the examination should still be performed at a facility where you can receive appropriate counseling and full mental and physical support so that you can make a choice you will not regret.

In addition to the further increase in the number of NIPT-certified facilities in the future, there is a possibility that conditions will be further relaxed so that as many pregnant women as possible can undergo testing with peace of mind, as was the case with the recent change in the conditions for pregnant women who are eligible for NIPT.

Even at facilities that have changed the conditions, they do not strictly say that testing is possible at the age of ●, but rather that it will be done after consultation on an individual basis.

Pregnant women themselves, as well as couples and families with concerns, should begin by understanding NIPT.

Then, receive full support so that you can make the right decision without regret, no matter what the outcome.