TEP Story Archives: Identifying Latent Cerebral Infarction with a Blood Test for the First Time in the World

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Dr. Kazuei Igarashi
President of Amine Pharma Research Institute/Member of TEP

The final biomarker for the three major causes of death

The three major causes of death in Japan are cancer, heart disease, and brain disease. Of these three, a blood test can show an indication of cancer and heart disease. That is because a component in the blood that indicates the presence of a disease, called a "biomarker," can be identified. However, identifying the biomarker for brain disease has been a challenge in the medical world for many years.

It was Dr. Kazuei Igarashi, president of Amine Pharma Research Institute (Amine Pharma) and honorary professor of Chiba University, who succeeded in its identification. During his research at the graduate school of Chiba University, he focused on a component called "acrolein," which is strongly related to cerebral infarction. He then founded a company in 2007 and identified this component as the first biomarker of cerebral infarction. In 2009, the company started a blood test service for evaluating the risk of cerebral infarction with about 85% accuracy.

There is estimated to be approximately 10 million people in Japan at risk of cerebral infarction due to high blood pressure and hyperlipidemia, but only 100,000 people annually take a MRI brain scan, which is the conventional method for diagnosing the disease. Most of these people live without symptoms while at risk of a sudden cerebral infarction occurring someday.

The cost of being hospitalized for 60 days due to cerebral infarction is about 2.7 million yen. The cost to the patient is high, at about 600,000 yen, but the price of these medical costs on society is even higher.

Amine Pharma’s cerebral infarction risk evaluation service has the potential to eliminate this problem if it becomes widely adopted as an initial test. People found to be at high risk can be recommended to take an MRI brain scan for a more detailed examination, and people at low risk can be recommended by the doctor to make lifestyle improvements, which will greatly contribute to early discovery and prevention of cerebral infarction.

The key to adoption is a low-cost service

The advantage of the cerebral infarction risk evaluation service is that it is simple and low-cost. It normally costs about 40,000 to 70,000 yen for an MRI brain scan, but this new service costs a mere 10,000 yen. Since the test only requires a simple blood sample, it is extremely easy on the test subject.

Response was swift, and by January 2012 over 130 medical institutions had adopted the service. The company is expected to achieve single-year profitability in the fifth year since its foundation. This is revolutionary for a biotech company, where the basic development period is long, and it is difficult to achieve commercialization.

Of course, not everything went smoothly from the beginning. The company experienced the trials faced by any other bio-venture companies when it was founded. With pharmaceutical research, it is common for capital expenses to be higher than regular companies due to the need to purchase laboratory instruments and specialized chemicals. This was also true with Amine Pharma, but thanks to subsidies from the New Energy and Industrial Technology Development Organization (NEDO) among others during the basic development phase, the company was able to overcome this difficult period.

At the time, Dr. Igarashi said, "A cerebral infarction marker is needed by society. We have the responsibility to bring this technology to the world," and his conviction is unwavering.

TEP pros support business expansion

The turning point for Dr. Igarashi's business was when he joined TEP in 2009 after an introduction from an industrial development officer of Chiba Prefecture. In order to put increased effort into sales activities, he gave a presentation to TEP angel investors on the current status and future outlook of his business to raise financial assistance.

That is where Dr. Igarashi came in contact with Mr. Tatsuo Shigeta, who is a TEP angel member and president of his own company, Think Laboratory Co., Ltd. When Mr. Shigeta heard the presentation, he was surprised and found himself thinking, "Why is such a wonderful technology not widely adopted?" Several meetings later, he decided to invest in Amine Pharma. Not only did he provide financial assistance, but he also joined as an outside director to provide management support.

Dr. Igarashi looks back on his meeting with Mr. Shigeta and his rich business experience as something that was essential to his company. Of course, the financial assistance he provided was helpful, but the most helpful thing of all was his support for sales expansion. The first result of this support was the blanket contract that the company entered with the Chiba Prefecture Machinery and Metal Health Insurance Association. Incorporating the company's test in health checks greatly increased the number of users of the test service. This was the first time that the company was able to enter a contract with a health insurance association rather than a separate medical institution.

Venture companies developed by universities often fail to achieve accelerated business growth and stagnate because of a lack of business knowledge amongst their staff. Amine Pharma steadily increased its customers via sales to separate medical institutions but was unable to achieve rapid growth due to limited sales manpower. Entering a contract with a health insurance association was the very thing needed to dispel this feeling of despair. Having a prior example made it easier to reach agreements with other associations, and several more are planning to adopt the system in 2012.

Creating a new global standard for health checks

"In the 59 years from 1950 to 2009, the global population of people over 60 years old increased by 350%, from 205 million to 737 million. By 2050, this is expected to increase a further 300%, to 2 billion people. It is possible that Amine Pharma could provide its service to all of these people, and this number increases further if we look at everyone over 50 years old, which is the recommended age for risk management," says Dr. Igarashi, who already has the entire world in his sights. With increasing medical costs in many developed countries becoming a national challenge, the need for such a service is high.

However, global expansion is not easy, due to various challenges such as the need to link with reliable clinical test companies and the need to establish operation methods that conform to the health check standards of each country

Despite this, Dr. Igarashi asserts that "Although we face many hurdles, I want to start by expanding to Asia in the next few years. As tests for metabolic syndrome have recently become commonplace, I strongly believe that we can do the same with cerebral infarction risk evaluations."

His confidence is backed by strong technical ability. The day when Amine Pharma and its small team of five regular employees led by Dr. Igarashi will create a new global standard for health checks is surely drawing close.

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