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Consider the testing companies used by non-accredited clinics.

Consider the testing companies used by non-accredited clinics.

Recently, an increasing number of unlicensed clinics in Japan are offering NIPT testing, which may be an option for those who are interested in NIPT testing.

Introduction.

Recently, an increasing number of unlicensed clinics in Japan are offering NIPT testing, which may be an option for those who are interested in NIPT testing.

One of the concerns here may be "whether the test is accurate or not. In this article, we would like to answer such a question by discussing the accuracy of the NIPT test at non-accredited clinics in Japan.

Most non-accredited clinics in Japan are inspected by foreign companies.

Most non-accredited clinics in Japan have business partnerships with overseas testing companies to perform tests based on information collected through diagnostics. Therefore, it takes 7 to 10 days to receive the test results.

They are outsourced to foreign companies, and those countries vary from clinic to clinic. Nevertheless, not many companies have entered the NIPT market.

Below is a rough list of the testing companies used by clinics in the central Tokyo area as an example.

  • Yaesu Sem Clinic -- Verinata Corporation (U.S.)
  • Jingu Gaien Minerva Clinic -- Verinata (U.S.)
  • Each facility of the consortium - Sequenom (U.S.)
  • Tokyo Evergreen Clinic - YourGeneHealth (UK)
  • NIPT Hiraishi Clinic - YourGeneHealth (UK)
  • ACLINIC Ginza・・・Yuadine Health (UK)
  • DNA Advanced Medical Corporation・・・Yuagine Health (U.K.)
  • Aoyama Lajbo Clinic - Lifecodex (Germany)
  • Ginza MITA Clinic - NMCK (Taiwan)
  • ange Clinic Bashamichi - NMCK (Taiwan)

As can be seen from the above, the number of inspection companies that the clinics request inspections from is generally limited to five. Incidentally, Lifecodex, which the Aoyama Rajubo Clinic requests inspections from, has an exclusive contract with them. The next section will discuss the reliability of the testing companies that have a business alliance with each clinic.

Reliability of the inspection company

NIPT testing was first introduced into clinical practice in countries such as the United States when it was first becoming popular. The following companies have held a significant share of the global market since around 2014 as leading players in countries where NIPT was first introduced.

  • Verinata Corporation (U.S.)
  • Sequenom, Inc.
  • Sequenom Corporation (U.S.)
  • Ariosa Corporation (U.S.)

In addition to these four companies, Chinese companies BGI and Berry Genomics have entered the market and are competing for market share. Nevertheless, the thought may occur to you, "I am worried about ordering testing from a Chinese company.

In fact, in China, prenatal testing errors have led to a wave of lawsuits: according to information released in 2018, Hua Dai Basic Technology Company (BGI), a major Chinese company with a presence in Japan, has been accused that of the approximately 2.8 million NIPT tests it performed by the end of 2017, approximately The story is startling: out of the approximately 2.8 million NIPT tests performed by the end of 2017, 15,000 healthy fetuses may have been aborted for possible disability.

BGI had reported "close to 100%" regarding the accuracy of NIPT test results until 2017, but later reversed that claim when pursued by the media and public opinion.

Reference: D.C. "The China: 15,000 healthy fetuses aborted due to prenatal diagnosis error?

This is a frightening story, which is why it is very important in selecting a clinic to find out if the NIPT testing company is trustworthy.

In the case of a reputable testing company, there are cases in which they have published papers that have a high reputation in accordance with medical evidence. The "high evaluation" here refers to the number of citations of the paper in other literature and the author's other achievements, which are quantified on academic websites, so it is easy to check the quality even without specialized knowledge.

The formula "many published papers = many clinical specimens" is a good indicator that the company is a "reliable company" with a large number of inspections and accumulated know-how.

If you have any doubts about choosing a clinic in Japan, we recommend a clinic affiliated with Benarita, the largest company in Japan.

In light of the above, it can be said that the most reliable of the testing companies affiliated with the Tokyo clinics indicated above is Verinata, the only company that has published academic papers.

Incidentally, Verinata is a subsidiary of Illumina, which develops life science tools and systems for large-scale analysis of genetic polymorphisms and gene function.

Illumina also develops NIPT testing equipment. Therefore, testing performed at Verinata, a direct subsidiary of Illumina, is guaranteed to be the most up-to-date testing environment available. And it is not only Verinata that uses Illumina's testing equipment, but also Sequenom, Natera, and Ariosa, which were introduced earlier, also use Illumina's equipment.

Other companies in Germany and Taiwan are also using them, and virtually all NIPT testing companies are using Illumina's testing equipment for NIPT testing. The reason for this stems from a 2014 agreement between Illumina and Sequenom to consolidate all patents related to NIPT into a patent pool.

This allowed the four major players, who had long been embroiled in patent litigation, to expand the market at once, contributing greatly to the spread of NIPT testing.

Summary

I have digressed a bit, but based on the above, I think it is safe to say that if a clinic wants to use the affiliated testing company as a reference in selecting a clinic, it should be a clinic that outsources its testing to Benarita, a direct subsidiary of Illumina.

Of course, the "selection of clinics by testing companies" introduced here is only one criterion. In selecting a clinic for prenatal testing, it is necessary to take into account various factors such as the doctor's interview, the quality of the examination at the clinic, and the cost involved.

Prenatal testing is an important test that can determine the future of the unborn child. Therefore, it is natural to want to have a proper test, but this may be difficult to do if you do not have enough information to choose the right clinic. We hope that you will find the information in this article useful in choosing a NIPT clinic.