NIPT (new prenatal diagnostic test) specimen testing laboratory, FALCO Biosystems fire

NIPT (new prenatal diagnostic test) specimen testing laboratory, FALCO Biosystems fire

This article is about the impact of the FALCO Biosystems fire, a NIPT (new prenatal diagnosis) specimen testing laboratory.

Fire at FALCO Biosystems Research Institute, a NIPT (new prenatal diagnosis) laboratory

A fire broke out at FALCO Biosystems Research Laboratories, Inc., a subsidiary of FALCO Holdings, Inc., a major clinical testing contractor on the First Section of the Tokyo Stock Exchange. Details are as follows.

  • Date, time, and circumstances of occurrence: fire broke out at approximately 8:30 a.m. on Sunday, February 3, 2019, and was extinguished at approximately 11:00 a.m.
  • Location: FALCO Biosystems Research Laboratories, Inc.
  • Fire origin: Microbiological inspection area on the 2nd floor of the facility
  • Cause of fire: Under investigation

About Falco Biosystems

The fire did not appear to have caused any human casualties, but the group has lost approximately 50% of its normal processing capacity for specimen testing. In addition, the processing capacity for some special items has been completely lost, and the resumption of operations is expected to take several months.

FALCO Biosystems is an organization that accepts blood and urine samples from medical institutions and also accepts NIPT (new prenatal diagnosis) specimens. Currently, there are very few institutions in Japan that accept NIPT specimens, which must be a big blow to facilities and medical institutions that perform NIPT testing.

Revision of Medical Law on NIPT Testing

Due to a December 2017 amendment to the Medical Care Act, specimens, including blood tests, cannot be sent directly overseas from medical institutions. The system makes it impossible to obtain test results without going through a specimen consignment facility such as FALCO Biosystems.

The medical law is described below.

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

(2) When the administrator of a hospital, clinic or midwifery home intends to entrust the services of specimen testing, he/she shall entrust the following persons

(i) Establishers of medical laboratories registered under Article 20-3, paragraph (1) of the Act on Clinical Laboratory Technicians, etc.

(ii) A person who performs the services of Specimen tests in hospitals or clinics or other places specified by an Ordinance of the Ministry of Health, Labour and Welfare, and whose structure, equipment, management organization, methods of ensuring the accuracy of Specimen tests and other matters of the facility where he/she performs the services of Specimen tests conform to the standards specified by an Ordinance of the Ministry of Health, Labour and Welfare as necessary for the proper performance of the services of Specimen tests

Specimens are mostly shipped to the U.S.

With examples such as the NIPT specimen determination error in China, it will be especially important to confirm which institution is transporting the specimens when receiving NIPT testing in the future.

At this time, many facilities request testing from U.S. laboratories such as Verinata Health, and it is safe to say that many of these facilities are safe.