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50 Smartest Companies of the Year 2019

Yoshiyuki Sakuraba, Varinos CEO:‘Our Mission is to Apply Genomic Technology to Medical Practice in a Timely Manner’

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“Everyone has to fill the missing part for the company and to not afraid of challenges.”

Varinos, headquartered in Tokyo, was set up in 2017 as a collaborative effort by Yoshiyuki Sakuraba and Yoko Nagai. It is a clinical testing company that provides genomic testing services with a special focus on reproductive health and aims to provide better prenatal care and help combat issues like infertility. Varinos pairs its top-of-the-line technology along with constant innovation to provide timely care. The company was one of the first in Japan to break the barriers of tradition and venture into genome testing. Its next-generation sequencing has helped understand problems concerning pregnancy as well as helped many Japanese women to conceive.

In Conversation with Yoshiyuki Sakuraba, Varinos CEO

Q. Why was the company set up? And how did you expand your company and its offerings over the years?

No one had started genomic applications, probably because Japanese businesses were too conservative. We started to think that if we become the first penguin, we can break the conservative situation in Japan. We founded Varinos, Inc. 2.5 years ago. We have recruited top-class personnel and built an experienced NGS team. As a result of this team building, we achieved the practical use of Endometrial Microbiome Test for the first time in the world with very short development period. With a focus on the reproductive health space, Varinos currently provides endometrial microbiome tests and PGT-A (preimplantation genetic testing for aneuploidy) to improve pregnancy rate for infertility couples.

Q. How successful was your first project roll on? Share the experience.

Our first project was to develop and practicalize the Endometrial Microbiome test for fertility treatment. In December 2017, we launched the Endometrial Microbiome test to Japanese ART/IVF clinics and Ob/Gyn physicians in University hospitals. Post collaboration with the physicians, we accumulated clinical evidence and methods of clinical intervention for fertility treatment. Now more than 90 clinics and University hospitals have been using our test for the infertility treatment and also basic research of other genital diseases such as endometrial cancer, HIV infection, HPV infection, endometriosis, endometritis, recurrent implant failure, chorioamnionitis, and preterm birth.

Q. What has been the greatest challenge you faced and what was your learning from it?

Our greatest challenge in the endometrial microbiome analysis is how we can minimize the effect of environmental bacteria, which could confuse us when reporting the results. We had been establishing a method to analyze low-biomass endometrial microbiota since the uterine bacterial load is estimated between 100 and 10,000 times fewer bacteria than the vaginal one, thus, it has been thought as sterile until several years ago. NGS technology is so sensitive and exhaustive that we can detect bacteria in uterine, which contains extremely low biomass. If you don’t eliminate the noise come from environmental bacteria, it could result in false results, not as it really is. With our distinctive inventions on the analysis method, we achieved to minimize the effect of environmental bacteria and to establish the special method detecting the uterine-derived bacteria very sensitively. We conduct quality control (QC) at key points as part of the inspection process, thoroughly control the quality, and incorporate an experiment management system and data analysis automation to minimize human error.

Q. Is your company a ‘leader’ or a ‘follower’? Do you formulate your own core values?

We are a leader in the Endometrial Microbiome testing space. We started the testing service in 2017, which is one year advance to a competitor. As a genomic clinical test company, we are a follower in worldwide point of view. Our mission is to apply genomic technology to medical practice in a timely manner. We have been developing several original technologies and applications using next-generation sequencer (NGS) and providing entirely new clinical tests. Our competitive edge is the outstanding capacity for technological development in this NGS field.

Q. What kind of responses have you received from your consumers over the years? How have they motivated you to shape your offerings/grow the company?

Most of the customers (reproductive medicine physicians) are satisfied with our high-quality tests and we got a lot of feedback that infertile patients got pregnant after prebiotic interventions based on our test. Other perinatal physicians used our test to find pathogenic bacteria from patients suffering threatened premature delivery with high fever. Mycoplasma and Ureaplasma are pathogenic bacteria causing premature delivery; however, conventional culture methods can’t detect those bacteria. We successfully detected Ureaplasma in low biomass amniotic fluid samples and helped physicians to select proper antibiotic quickly, even though the culture test result was negative. To operate the clinical-grade genomic test, expert knowledge is required. So we have recruited top-class personnel and built an experienced NGS team.

Q. What kind of social welfare projects are you involved in?

Correct sex education and infertility treatment from a younger age is indispensable to solve the problem of declining birthrate in Japan. In order not to increase the number of people suffering from infertility due to lack of knowledge, it is very important to provide people with the correct knowledge of uterine conditions and chromosomal abnormalities caused by aging of eggs and sperm. We think it is a social responsibility for our company.

Q. Do you have any new products ready to be launched?

We have established the world’s first clinical laboratory endometrial microbiome analysis test service and have already analyzed more than 5,000 infertile samples. Using in-house data, we continuously update tests to be more accurate such that it can detect “species” level microbiome. To unlock the power of genome for humanity, we are planning to start the following tests: PGT-SR (preimplantation genetic testing for structural rearrangement) for pregnancy success, PGT-M (preimplantation genetic testing for monogenic diseases), and PGT-P (preimplantation genetic testing for polygenetic diseases).

Leadership | Varinos

Yoshiyuki Sakuraba, Ph.D.: Yoshiyuki Sakuraba, CEO and Co-founder, is an expert on reproductive and genetic health. He is also an ex-Executive Clinical Sales Specialist of Illumina which is focused on Reproductive & Genetics Health market. He is also an ex-R&D Manager of GeneTech, Inc which was when he first introduced NIPT to Japan from Sequenom.

Yoko Nagai, Ph.D.: Yoko Nagai, CTO and Co-founder, is an expert on population genetics and microbiomes. She is an ex-Sequencing Specialist of Illumina where She launched a microbiome hand-on workshop and consulted more than 300 researchers.

“We can accelerate modern medicine with our latest technology this is why customers choose our service.”