Considering the Inspection Companies Used by Unlicensed Clinics

Introduction

Recently, the number of unlicensed clinics conducting NIPT tests has been increasing in Japan. When considering NIPT testing, these clinics may also come up as an option.

One concern is whether the tests are accurate. In this article, we will explore the accuracy of NIPT tests conducted by unlicensed clinics in Japan, to provide guidance for choosing a clinic.

All Unlicensed Clinics in Japan Use Overseas Companies for Testing

Most unlicensed clinics in Japan partner with overseas testing companies to conduct tests based on collected diagnostic information. Therefore, it takes about 7 to 10 days to receive test results.

The countries of these overseas companies vary depending on the clinic, but there are not many companies in the NIPT market.

Below is a general list of the testing companies used by clinics in central Tokyo.

• Yaesu Sem Clinic - Verinata (USA)
• Jingu Gaien Minerva Clinic - Verinata (USA)
• Consortium Facilities - Sequenom (USA)
• Tokyo Evergreen Clinic - Yourgene Health (UK)
• NIPT Hiraishi Clinic - Yourgene Health (UK)
• ACLINIC Ginza - Yourgene Health (UK)
• DNA Advanced Medical Co., Ltd. - Yourgene Health (UK)
• Aoyama La Ju Beau Clinic - LifeCodexx (Germany)
• Ginza Mita Clinic - NMCK (Taiwan)
• Ange Clinic Bashamichi - NMCK (Taiwan)

As you can see, the testing companies used by these clinics are generally limited to five. Aoyama La Ju Beau Clinic has an exclusive contract with LifeCodexx. The next section will delve into the reliability of these companies.

Reliability of Inspection Companies

When NIPT testing began, it was first introduced in clinical settings in countries like the USA. Since around 2014, the following companies have held significant shares in the global market as early players:

• Verinata (USA)
• Sequenom (USA)
• Natera (USA)
• Ariosa (USA)

In addition to these four companies, Chinese companies BGI and Berry Genomics have entered the market. However, there may be concerns about relying on Chinese companies for testing.

In China, lawsuits due to prenatal testing errors have been frequent. According to information released in 2018, Chinese giant BGI (Beijing Genomics Institute) was accused of causing about 15,000 healthy fetuses to be aborted due to erroneous NIPT test results by the end of 2017.

BGI initially reported almost 100% accuracy for its NIPT test results until 2017, but later retracted this claim under media and public scrutiny.

Reference: Epoch Times "China: 15,000 Healthy Fetuses May Have Been Aborted Due to Prenatal Testing Errors"

This highlights the importance of verifying the reliability of NIPT testing companies when choosing a clinic.

Reputable companies often publish highly regarded scientific papers based on solid medical evidence. The quality of these papers can be assessed by their citation count and the author's other achievements, which can be easily checked on academic sites.

"More published papers = more clinical samples" means the company has accumulated significant testing experience and expertise, indicating a reliable company.

If Unsure About Choosing a Clinic, Opt for One Partnered with the Largest Company, Verinata

Based on the above, the most reliable company among those partnered with Tokyo clinics is Verinata, the only one publishing academic papers.

Verinata is a subsidiary of Illumina, a company that develops life science tools and systems for large-scale analysis of genetic polymorphisms and gene functions.

Illumina also develops NIPT testing equipment, so tests conducted by Verinata use the latest testing environments. Other companies like Sequenom, Natera, and Ariosa also use Illumina equipment.

German and Taiwanese companies also use Illumina equipment, meaning almost all NIPT testing companies use Illumina’s equipment. This stems from a 2014 agreement to pool NIPT-related patents between Illumina and Sequenom.

This agreement resolved long-standing patent disputes among the major four companies, allowing rapid market expansion and contributing significantly to the widespread adoption of NIPT testing.

Conclusion

To summarize, if you want to consider the testing company used by a clinic as a factor in choosing a clinic, it would be prudent to select one partnered with Verinata, a subsidiary of Illumina.

Of course, the "selection based on testing company" introduced here is just one criterion. Choosing a clinic for prenatal testing should also consider factors like the doctor's consultation, the quality of the clinic's examinations, and the costs involved.

Prenatal testing is an important examination that can determine the future of the unborn child. Naturally, you want to ensure proper testing, but it can be difficult without sufficient information to choose a clinic. I hope this article helps you in selecting a clinic for NIPT.