NIPT (New prenatal diagnosis) testing agency, the impact of the Falco Biosystems fire

Falco Biosystems Research Institute Fire at NIPT (New Prenatal Diagnosis) Testing Agency

There was a fire at Falco Biosystems General Research Institute, a subsidiary of Falco Holdings Co., Ltd., a major clinical testing contractor listed on the First Section of the Tokyo Stock Exchange. The details are as follows:

• Date and Time of Occurrence: The fire broke out on Sunday, February 3, 2019, around 8:30 AM and was extinguished around 11:00 AM.
• Location: Falco Biosystems General Research Institute, 17-1 Tainishi Arami, Kumiyama-cho, Kuse-gun, Kyoto Prefecture
• Origin of Fire: Microbiology testing area on the second floor of the facility
• Cause of Fire: Under investigation

About Falco Biosystems

It appears that there were no human casualties in the recent fire, but the group has lost about 50% of its normal processing capacity for specimen testing. Additionally, the processing capacity for some specialized items has been completely lost, and it is expected to take several months to resume operations.

Falco Biosystems is an organization that receives blood, urine, and other specimens from medical institutions, and it also handles specimens for NIPT (New Prenatal Diagnosis). Currently, there are very few organizations in the country that handle such specimens, so this is likely to be a significant blow to facilities and medical institutions conducting NIPT tests.

Revision of Medical Law Regarding NIPT Testing

Due to the revision of the Medical Care Act in December 2017, medical institutions can no longer send specimens, including blood tests, directly overseas. Instead, it is necessary to go through specimen contracting facilities like Falco Biosystems to obtain test results.

The Medical Care Act stipulates the following:

[Article 15-3, Paragraph 1 of the Medical Care Act]

When the manager of a hospital, clinic, or maternity home intends to outsource specimen testing, they must outsource to the following entities:

1. The operator of a sanitary inspection office registered under Article 20-3, Paragraph 1 of the Clinical Laboratory Technicians Act.
2. An individual who conducts specimen testing at a hospital, clinic, or other locations specified by the Ministry of Health, Labor, and Welfare ordinance, provided that the structure, equipment, management organization, methods for ensuring the accuracy of specimen testing, and other matters of the facility where the individual conducts specimen testing conform to the standards specified by the Ministry of Health, Labor, and Welfare ordinance as necessary for the proper conduct of specimen testing.

Specimens are Mainly Transported to the United States

There have been examples of NIPT specimen evaluation errors in China, making it particularly important to verify which agency the specimens are being sent to when undergoing NIPT tests in the future.

Currently, many facilities request testing from American testing agencies such as Verinata Health, which can be considered reassuring. When looking up testing agencies on their websites, logos and other marks can serve as helpful indicators, so it is a good idea to check them.