BD Biosciences announces availability of new CD4 technology in Africa

Nairobi, Kenya and Johannesburg, South Africa, (November 6, 2008) - BD Biosciences, a segment of BD (Becton, Dickinson and Company), today announced immediate availability of new BD FACSCount™ CD4 reagents throughout Africa.

In Africa, the BD reagents will help address the continent's need to implement more effective and rapid immune system monitoring for patients who are benefiting, or could benefit, from anti-retroviral medicine (ARV). The BD FACSCount system is already widely used in 48 countries in Africa.

The announcement follows the U.S. Food and Drug Administration granting BD clearance to market this new technology which provides both absolute CD4 counts and percentage results from an easy-to-use single-tube test.

The level of CD4 in an individual's blood, an indicator of when to initiate and response to antiretroviral therapy (ARV) therapy, can be measured in two ways: CD4 count and CD4 percentage.

The absolute CD4 count measures the number of functional CD4 T cells circulating in the blood - the lower the CD4 count, the weaker the immune system. CD4 percentage represents the percentage of total lymphocytes that are CD4 cells.

“Accurate diagnostic and monitoring tools are essential for effective treatment of HIV/AIDS and other diseases associated with it,” said Nick Bright, General Manager, BD in Kenya. “The new BD FACSCount CD4 reagents enable healthcare providers to use one test to provide effective care for all patients - regardless of their age.”

The BD reagents, used on the established BD FACSCount flow cytometry system, provide both absolute CD4 counts and percentage results from an easy-to-use single-tube test. Percentage CD4 results are preferred for children with HIV/AIDS, but until now, this capability had not been readily accessible in Africa. Children in need of therapy might be inappropriately treated because their absolute CD4 counts exceed the minimum recommended level to initiate therapy.

Additionally, the single reagent tube, used for both CD4 absolute counts and percentages, can be accurately processed and analyzed in 40 minutes - nearly half the time of similar products. This allows doctors and nurses to more quickly address the needs of their patients and enables laboratory technicians to analyze more samples a day.

“The system's simplicity makes the reagents both cost effective and realistic to use in resource-limited settings, such as the African continent,” said Peter Mehlape, General Manager, BD South Africa. “Laboratories that already have the BD FACSCount system do not need to be upgraded, which will help to save financial and human resources.”

“The new system simplifies the provision of care, allowing for more efficient use of healthcare workers' time and other necessary resources,” said Patrick Bouic, Professor, Department of Medical Microbiology, University of Stellenbosch. “The use of this technology will help to ease patient load and patient waiting times at health facilities by providing more reliable results more quickly - thereby reducing the need for more frequent patient follow ups or more costly interventions.”

The new BD FACSCount CD4 reagents are included in BD's agreement with the William J. Clinton Foundation, which strives to improve access to critical HIV/AIDS, tuberculosis and malaria control tools across Africa. Under the amended agreement, the price of the new BD reagents is steeply discounted to improve access.