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Expansion of NIPT (new prenatal diagnosis) facilities to be postponed for the time being?

Expansion of NIPT (new prenatal diagnosis) facilities to be postponed for the time being?

On June 22, 2019, the Japanese Society of Obstetrics and Gynecology (JSOG) held a board meeting and decided to suspend the implementation of the new guidelines for the time being in order to expand the number of facilities for NIPT implementation, due to the fact that the Ministry of Health, Labor and Welfare's study group decided to discuss how the NIPT implementation facilities should be.

Discussion on the state of NIPT facilities

NIPT (new prenatal diagnosis) is a common test in the United States. With the increase in the number of older births, the number of pregnant women undergoing NIPT testing in Japan has been increasing year by year.

The Japan Society of Obstetrics and Gynecology has set conditions such as limiting NIPT recipients to 35 years of age or older, and only licensed facilities are allowed to perform NIPT testing. However, as demand for NIPT increases, the number of unlicensed facilities that can perform the test for those under 35 years of age is increasing.

On June 22, 2019, the Japanese Society of Obstetrics and Gynecology (JSOG) held a board meeting and decided to suspend the implementation of the new guidelines for the time being in order to expand the number of NIPT facilities, since the Ministry of Health, Labor, and Welfare has decided to discuss how NIPT should be implemented in the future.

Until now, amniotic fluid testing has been performed only for those who have given birth at an advanced age or whose fetus is suspected of having a genetic abnormality such as Down's syndrome. In contrast, NIPT can detect chromosomal abnormalities such as 13.18.21 trisomy simply by examining a pregnant woman's blood, thereby minimizing risks to the mother and fetus.

Of course, NIPT is not a definitive diagnosis, and an amniotic fluid test, which is a definitive diagnosis, should be performed when NIPT is positive, but the existence of a test that provides a cushion before the amniotic fluid test is important both physically and mentally.

Current status of licensed and unlicensed facilities

While a negative NIPT test result may allow a woman to give birth with peace of mind, a positive result often leads to abortion. Therefore, it is true that the NIPT test itself is a cause for concern, as it can be life-selective.

This is one of the main reasons why NIPT is approved by the Japanese Society of Obstetrics and Gynecology (JSOG) only for approved facilities. In reality, however, licensed facilities are more expensive than unlicensed facilities and have age restrictions, giving the impression of a higher threshold.

Many unlicensed facilities now offer a full range of testing services, including subsidized amniotic fluid testing, counseling by genetic counselors, and testing for all chromosomes.

The Future of NIPT

The more unlicensed facilities increase, the more they will compete with each other, and the higher the level of facilities will become in order to meet the needs of consumers in terms of price and technology, which is a good thing. As the number of unauthorized facilities increases, they will compete with each other and raise the level of facilities in order to meet the needs of consumers in terms of price, technology, etc. This will lead to more readily available and accessible testing.

Times are changing, and people, medicine, and technology are evolving every day. We look forward to seeing how NIPT will change in the future.

The Japan Society of Obstetrics and Gynecology held a meeting of its Board of Directors on February 22 regarding the "new prenatal diagnosis," which uses a pregnant woman's blood to test for Down syndrome and other fetal chromosomal abnormalities, and decided to put off for the time being the implementation of new guidelines aimed at expanding the number of facilities where the procedure can be performed. The reason for this decision is that the Ministry of Health, Labor, and Welfare has decided to hold a study session to discuss how the procedure should be implemented.

The new guidelines allow small general practitioners to perform the test if they meet certain conditions, which was opposed by the Japan Pediatric Society and the Japan Society of Human Genetics. On the other hand, the number of private clinics that ignore the guidelines and offer testing has been increasing, and the MHLW decided that a national response was necessary to avoid confusion.

There are cases in which a new prenatal diagnosis results in an abortion, and it has been pointed out that this could lead to the selection of life. For this reason, only about 90 facilities nationwide accredited by the Japan Medical Association are allowed to perform the test, and they do so in accordance with the rules of the Japan Society of Obstetrics and Gynecology. However, an increasing number of private clinics are conducting tests without following the rules. As a countermeasure, in March of this year, the Japanese Society of Obstetrics and Gynecology announced a new draft guideline, which states that even small hospitals such as general practitioners can perform the test as long as they have a trained obstetrician/gynecologist.

The Board of Directors officially approved the program at its meeting on December 22, but operations will be frozen until the government's discussion is determined. Approximately 90 facilities currently approved will be allowed to continue inspections.

The policy of the MHLW to set up a study group was conveyed in writing to the academic society by the person in charge on March 21.

A test in which blood samples are taken from pregnant women as early as 10 weeks after conception and DNA fragments related to the fetus are analyzed to determine three types of chromosomal abnormalities, including Down's syndrome. Even if a positive result is obtained, an amniotic fluid test is required to confirm the result. In Japan, the test has been conducted as a clinical research project since 2013. As of September last year, approximately 65,000 people had undergone the test, and 886 pregnant women had chromosomal abnormalities confirmed in their fetuses.