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Sysmex Develops Technology Concept for Management and Monitoring of HIV/AIDS


- A new concept combining its compact automated hematology analyzer, its IT and a commercially available measuring kit catering for the specific needs of African countries -

Information contained in the press release is current as of the date of the announcement, but may be subject to change without prior notice.

April 19, 2006, Sysmex Corporation (HQ: Kobe, Japan; President: Hisashi Ietsugu) announced today the establishment of a new technology concept helping to popularize a safe and easy measurement of CD4-positive peripheral blood cells*, a major element in managing the treatment of HIV carriers and AIDS patients. By using its automated hematology analyzer pocH-100i and Dynal T4 Quant Kit by Invitrogen Corporation** the company plans to market the new solution chiefly in African countries that are seriously affected by the HIV/AIDS epidemic.
At present, FCM (flow cytometry) in centralized laboratories is the most commonly chosen method for CD4-positive cell measurement and patient monitoring. Using a laser-based optical detection principle both, instruments and their reagents, are costly. In addition, the procedure requires well trained specialists. Featuring the CD4 counting on the compact automated hematology analyzer pocH-100i using electric resistance detection principle, the new solution, completed by a simple web based result communication software (K-Xpert CD4), makes the measurement fast and easier thus allowing efficient ART*** (anti-retroviral therapy) patient monitoring and surveillance also in remote locations – at controlled quality standards, connected with and supervised by competence centers that so far could not reach out to HIV/AIDS patients living far away from the centre itself. The new measurement also makes the initial investment and running cost lower compared to FCM.

The number of HIV carriers and AIDS patients combined is estimated to be 40 million worldwide, about seventy percent of which concentrated in Southern Africa. To address this issue, the World Health Organization (WHO) has launched programs for the prevention and treatment of HIV/AIDS, including the “3 by 5” initiative that aimed to make available ART to three million people with HIV/AIDS living in developing countries by the end of 2005. In response to their initiatives in this regard, a number of foundations in the United States and other countries are offering funds to support this target making it possible to accelerate treatment of the carriers and patients, as well as, education on the prevention of infection.

CD4-positive cell measurement is the major indicator for the progression of an HIV infection. It is the basis to decide when to start an ART and when to eventually change the treatment regimen. Usually a high-tech flow cytometer is required for the CD4-positive cell determination employing sophisticated laser technology. However, high expenses and the need for well trained specialists are limiting its usefulness in developing countries in Africa and other regions to large and centralized hospitals.

The new method that we have established for commercial use utilizes a tailor made measuring kit to pre-treat the patient-blood sample by removing all cells other than CD4-positive cells prior to fully automated measurement by our compact automated hematology analyzer pocH-100i. Results are processed by a specifically designed, simple software and can be sent via the internet as e-mail or as SMS (Short Message Service) from the remote point of care to a supervising centre. Thus, the centre can not only monitor individual disease progression of patients by centralized filing and following up all patient relevant data but, if necessary, the supervising centre can easily communicate by e-mail with the connected remote site.

Our tight sales and service network is covering almost the entire African continent with a service center in the Republic of Benin established in 2001 and representatives in some forty countries on the continent. The establishment of an affiliated company in the Republic of South Africa is under progress. By means of this extensive network in the African market it is ensured that also the ongoing educational need for the serviced centers and the global cooperation partners is served. In addition we will build up comprehensive marketing programs including solution sales of this innovative testing method, services, and academic support. By expanding our business in Africa with a diagnostic monitoring concept affordable and easy to handle we will contribute to the urgent combat with HIV/AIDS.
[ Terminology ]
* CD4-positive cells

T-Helper cell, a sub-type of human lymphocytes. The cells were named after a specific antigen on the surface of the T-helper cell’s membrane: CD4 (cluster of differentiation 4).
CD4-positive cells play a crucial role in the immune system, like the conductor of an orchestra. Because HIV invades and destroys the CD4-positive cells, the immune system of the infected patient no longer maintains its harmonious collaboration, resulting in fading or disappearing immune defense.
The number of CD4-positive cells thus reflects the actual condition of HIV carriers’ immune state and is a key indicator for HIV/AIDS treatment. WHO recommends that all HIV infected people with less than 200 CD4-positive cells/μl shall be offered antiretroviral therapy.

**Invitrogen Corporation

Invitrogen is the industry leader in magnetic bead technologies that are used in cell separation and purification, cell stimulation, protein research, nucleic acid research and microbiology, with a high share in the CD4-positive cell measurement kit market.

***Antiretroviral therapy (ART)

A therapy using antiretroviral drugs. Since three or more of such drugs are given in combination, it is also called “cocktail therapy,” “three medicine-using therapy,” or “highly active anti-retroviral therapy.”
For treatment of HIV/AIDS, antiretroviral drugs are administered to inhibit any of the steps in the replication of HIV, a variety of retroviral viruses.

[ About the measuring system ]
1) Automated hematology analyzer pocH-100i

2) CD4 measuring kit and sample pre-treatment accessories
3) Special data management system for hematology analyzer K-Xpert CD4
2. Launch date: April 2006
3. Market: Africa


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