Fujifilm and FIND* Sign Development Contract to Develop Highly Sensitive Rapid Tuberculosis Diagnosis Kit for Developing Countries

Fujifilm and FIND* Sign Development Contract to Develop Highly Sensitive Rapid Tuberculosis Diagnosis Kit for Developing Countries Receiving 216 Million Subsidy from Global Health Initiative Technology (GHIT) Fund**

31.03.2016

FUJIFILM Corporation (President: Shigehiro Nakajima) has signed a joint development contract with the Swiss non-profit organization FIND (Foundation for Innovative New Diagnostics) for the development of a highly-sensitive rapid tuberculosis (TB) diagnosis kit. The kit uses an immunochromatography*** method which applies silver halide amplification technology*4. FIND is an organization dedicated to advancing the development and adoption of new diagnostic technologies for infectious diseases that are suited for developing countries. Under this contract, FIND will support Fujifilm in the development of a convenient, rapid, low-cost TB diagnosis kit with high diagnostic capability for developing countries. This partnership has been selected for a subsidy by the Global Health Initiative Technology (GHIT) Fund, a fund for the development of innovative new treatments, vaccines, and diagnostic agents in Japan, receiving approximately 216 million. The timeline of development is from April 2016 through October 2017, for one year and seven months.

TB is one of the worlds major infectious diseases*5 infecting 9.6 million people, and causing the death of 1.5 million people*6 annually around the world. Of all TB patients, 86% are concentrated in developing countries in Africa and Southeast Asia*7. TB infections have a serious impact on the societies and economic activities of these countries due to the ongoing spread of the disease and the cost of medical treatment for patients. HIV is also common among populations in developing countries, and when people contract HIV, their immune systems are adversely affected, making HIV patients approximately 30 times more likely than healthy individuals to develop TB. Patients who have both TB and HIV frequently become critically ill, with one in three cases of such co-infections leading to mortality. Therefore, it is important to provide regular TB screening for people living with HIV in order to begin TB treatment at an early stage of the disease.

In developing countries, the diagnosis of TB is frequently carried out using a microscope to search a patients sputum for the presence of the bacteria that causes TB (Mycobacterium tuberculosis). However, one issue with this method of diagnosis is that accurate results cannot always be obtained due, for example, to failure to identify the TB bacteria or due to extrapulmonary tuberculosis, which is caused by the presence of TB-causing bacteria outside the lungs. In recent years, genetic analysis of sputum, which is highly reliable, has gradually become more widespread, but this method requires laboratory technicians with specialist techniques and expensive diagnostic equipment, in addition to a steady electricity supply. Therefore, the development of an alternative diagnostic method better suited for developing countries is a pressing issue. Furthermore, it is hoped that specimens other than sputum can be used for diagnosis since there are certain patients from whom it is difficult to obtain sputum, such as small children and elderly persons, and also because sputum diagnosis is not effective in the case of extrapulmonary TB, which affects numerous HIV patients.

Fujifilm and FIND have focused on lipoarabinomannan (LAM)*8, a compound specifically produced by TB that is excreted in the urine. By using Fujifilms highly sensitive virus detection technology, the silver halide amplification technology, Fujifilm and FIND will work to develop a kit suitable for resource-poor countries that will allow the prompt identification of the presence of the TB bacteria simply by placing a urine sample into a cartridge in a device that does not require electricity. The partners aim to develop a kit that can serve as a primary diagnostic tool for TB, including in HIV patients.

Fujifilm has already developed the highly sensitive immunochromatography influenza diagnosis system for identifying the influenza virus, and this was launched in Japan in October 2011. The system uses two different types of antibodies to identify the presence of a virus in the sample and, through simple operations, the results can be obtained in 3.5 to 15 minutes. By making use of the silver halide amplification technology used to develop photographs, this system achieves approximately 100 times the sensitivity of standard diagnostic agents*9. This proprietary technology, which allows the detection of very small volumes of influenza virus in the early stages of infection, has been highly appreciated and is being introduced at many medical institutions in Japan. Furthermore, Fujifilm is working to apply the technology to the detection of non-influenza infections such as adenovirus and the RS virus.

Fujifilm perceives solving social issues as an opportunity for growth in the medical business. Fujifilm will continue to proactively promote research and development to expand its operations and contribute to the development of medical care around the world, as well as maintain and promote public health through innovative products.

*NPO headquartered in Geneva, Switzerland. Established in 2003 as a global non-profit dedicated to accelerating the development, evaluation and delivery of high-quality, affordable diagnostic tests for poverty-related diseases, including tuberculosis, malaria, HIV/AIDS and so on. FIND has over 100 partners globally, including research institutes and laboratories, commercial partners and multilateral organizations, especially the World Health Organization, as well as clinical trial sites.

**GHIT (Global Health Initiative Technology) Fund. Established as a public-private sector partnership jointly by the Japanese

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