NIPT Contracted Testing

Our company offers NIPT services at the Tokyo Hygiene Laboratory.
In March 2022, the Tokyo Hygiene Laboratory received accreditation from the College of American Pathologists (CAP).

For Medical Institutions Considering NIPT Implementation

When requesting NIPT testing from an overseas laboratory, the specimen must be transported via a hygiene laboratory. (Failure to do so is punishable [Article 15-3, Paragraph 1 of the Medical Law]). Applications to each hygiene laboratory are expected to be in Japanese, and dealings from application to test results with overseas laboratories will likely be in English.

At the Tokyo Hygiene Laboratory, the entire process from application to result reporting is conducted domestically and in Japanese. The accuracy is equivalent to what is used in clinical settings abroad. The Tokyo Hygiene Laboratory fully supports the NIPT testing of your institution to assist busy doctors.
If you are a medical institution considering NIPT implementation, please check the following procedure and contact us through the contact form.

About Sample Collection

Target: 10 mL of whole blood from pregnant women at 10 weeks 0 days of gestation or later (in principle)
Blood collection container: Cell-Free DNA Streck tube

Sample Report

Since our NIPT testing is conducted in our domestic lab, all test results are reported in Japanese.

Guidelines for Test Provision

Our company provides NIPT testing in accordance with the following guidelines.

It is now possible to check the results directly from the system on a unit basis.

The traditional exchange via FAX and email has been replaced, and results can now be checked directly from the system on a clinic unit basis.

• Undecided about implementing NIPT
• Unsure of what needs to be done to implement
• Worried about being able to operate smoothly after implementation
• Don't fully understand NIPT

Please consult with us first!

Amniocentesis

NIPT is a screening test. If the test result is positive, a confirmatory test using amniotic or chorionic cells is required. We recommend amniocentesis for those who receive a positive NIPT result.

Testing Process

STEP 1

Blood Collection (Partner Clinic)

Please collect 10 ml of the mother's blood.

STEP 2

Specimen Shipment

Shipment is arranged by each clinic.

STEP 3

Testing

Analysis is conducted using next-generation sequencing at the Tokyo Hygiene Laboratory.

STEP 4

Test Results Notification

The test results will be communicated from the Tokyo Hygiene Laboratory to the medical institution. The original results will be in Japanese.

STEP 5

Reporting

The medical institution will report the test results to the patient.

Regarding Amendments to the Medical Law

Previously, specimens could be sent directly overseas, but to improve the accuracy of testing, a revision to the Medical Law in December 2018 prohibited the direct shipment of specimens, including blood tests, from medical institutions such as hospitals and clinics to overseas laboratories.
Newborn screening (NIPT) is also subject to the same measures. Please note that requesting NIPT directly from an overseas laboratory by a medical institution may result in legal penalties.
Our hygiene laboratory is registered and complies with the standards set forth by the Ministry of Health, Labour and Welfare.

[Article 15-3, Paragraph 1 of the Medical Law]
The manager of a hospital, clinic, or birthing center must commission specimen testing to one of the following:
1. The operator of a hygiene laboratory registered under Article 20-3, Paragraph 1 of the Clinical Laboratory Technician Act.
2. An individual conducting specimen testing operations at a place such as a hospital or clinic, where the facility structure, management organization, methods for ensuring the accuracy of specimen testing, and other matters are deemed necessary for the proper execution of specimen testing operations, and comply with the standards set forth by the Ministry of Health, Labour and Welfare.