Can Anyone Receive Prenatal Testing? Conditions and Age Restrictions

In recent years, prenatal testing has attracted growing attention as a way to detect fetal chromosomal abnormalities during pregnancy. Among the options, Non-Invasive Prenatal Testing (NIPT) has become increasingly popular because it only requires a maternal blood sample, carries minimal physical risk to the mother, and provides highly accurate results.

However, many people wonder: “Is NIPT available to everyone?” and “Are there age or eligibility requirements for testing?”
This article provides a detailed explanation of the actual conditions and age restrictions for NIPT in Japan, as well as the ethical and regulatory background, based on professional insights and evidence.

What is NIPT?

NIPT analyzes fragments of cell-free fetal DNA (cfDNA) found in maternal blood from 10 weeks of pregnancy onward to estimate the likelihood of fetal chromosomal abnormalities.
It primarily targets the following conditions:

• Trisomy 21 (Down syndrome)
• Trisomy 18 (Edwards syndrome)
• Trisomy 13 (Patau syndrome)

Accuracy is reported to be very high, with both sensitivity and specificity exceeding 99% (Bianchi et al., 2014).

Current Eligibility for NIPT in Japan

1. Testing at Accredited Facilities (per Japan Society of Obstetrics and Gynecology guidelines)

Accredited facilities designated by the Japan Society of Obstetrics and Gynecology (JSOG) require at least one of the following conditions:

• Pregnant women aged 35 or older
• History of a pregnancy or birth involving a chromosomal abnormality
• Ultrasound findings suggestive of chromosomal abnormality
• Family history of genetic disorders

These conditions reflect medical indications, based on the view that NIPT is a medical procedure that should be restricted to higher-risk pregnancies.

2. Non-accredited Facilities (Private Clinics)

Some private clinics, known as “non-accredited facilities,” allow anyone to undergo NIPT regardless of age at the discretion of the physician. While the test itself may be reliable, there are significant differences in genetic counseling, result explanation, and support systems, so choosing a facility requires careful consideration.

Is There an Age Restriction for NIPT?

• JSOG guideline: Sets 35 years or older as a benchmark. However, this has no legal binding power and is not due to test accuracy but rather ethical considerations and resource allocation.
• Research findings: Studies show that chromosomal abnormalities also occur in women in their 20s and early 30s, so NIPT remains clinically valuable in younger populations.

Why Are There Eligibility Conditions? Ethical and Social Background

• Concerns about universal screening: Offering NIPT to all pregnant women could create social pressure implying that “not giving birth to a child with abnormalities is preferable.”
• WHO perspective: The World Health Organization emphasizes the importance of “informed choice” in its guidelines on prenatal testing.
• Need for genetic counseling: NIPT is a screening test, not a diagnostic one. A positive result must be confirmed with invasive diagnostic tests (e.g., amniocentesis). Therefore, accurate understanding through counseling before and after testing is essential.

International Comparisons

• United States: Since 2017, the American College of Obstetricians and Gynecologists (ACOG) has recommended considering NIPT for all pregnant women, citing that chromosomal abnormality risk exists regardless of age.
• United Kingdom: The NHS provides NIPT to pregnant women identified as having a high risk of chromosomal abnormalities through initial screening, applying a risk-based approach, similar to Japan.

How to Decide if NIPT is Right for You

Key self-checkpoints:

• Are you 35 years or older at the time of pregnancy?
• Do you have concerns or family history of chromosomal abnormalities?
• Do you have a plan for how to respond to the results (diagnostic testing, pregnancy continuation, etc.)?
• Are you choosing a medical institution with reliable counseling services?

NIPT Testing Decision Flow

1. Around 10 weeks, your physician introduces NIPT as an option
2. Undergo genetic counseling (mandatory or optional depending on facility)
3. Understand benefits, limitations, and false-positive potential
4. Discuss the plan with your partner or family
5. Decide whether to proceed
6. Testing performed, results returned in about 1 week
7. If positive, consider confirmatory testing such as amniocentesis

What If the Result is Positive?

• NIPT is only a screening test — a “positive” result does not equal a confirmed diagnosis.
• About 5% false positives have been reported (Benn et al., 2019).
• Final confirmation requires invasive diagnostic testing (e.g., amniocentesis).

Trends Among Younger Women

• Growing demand among women in their 20s
  Despite official restrictions, more women in their 20s are requesting NIPT due to:
  • Early access to information via social media and the internet
  • Desire for reassurance
  • Higher awareness among educated or higher-income groups
  According to a 2021 Ministry of Health, Labour and Welfare report, about 7% of women in their 20s requested NIPT, with the number increasing annually.
• Cases of rejection due to age
  Some accredited facilities refuse testing to women under 35, forcing them to turn to non-accredited clinics. This highlights information and healthcare disparities in Japan’s current system.

Systemic and Ethical Considerations

1. Insurance coverage and system reform
   In Japan, NIPT is usually self-funded, costing ¥100,000–200,000. This high cost prevents some women from accessing it. Systems similar to other countries, such as partial public funding, are needed.
2. Dual structure of accredited vs. non-accredited facilities
   Accredited facilities impose strict conditions, while non-accredited facilities allow nearly universal access. This inconsistency raises questions about fairness.
3. Improved information dissemination
   Some women undergo NIPT without fully understanding it. Easy-to-understand resources and better communication from doctors and counselors are essential.

NIPT and the Value of “Choice” and “Information”

Technically, NIPT is now available to anyone.
In practice, however, guidelines and systems still create disparities between those who can and cannot access it.

Therefore, the focus should be on:

• Ensuring equal access to accurate medical information regardless of age
• Providing psychological and institutional support for handling results
• Seeing the test not as the goal itself but as part of making informed life choices

Future prenatal testing policy in Japan must evolve toward “fairer and safer healthcare for all pregnant women and families.”