Full Press Release Details
SAN JOSE, Calif. , Sept. 23, 2014 /PRNewswire/ -- BD Biosciences, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX ), a leading global medical technology company, today announced that the World Health Organization (WHO) has issued a report prequalifying the BD FACSPresto™ Near-Patient CD4 Counter system for the enumeration of CD4 count to determine eligibility for initiation of Antiretroviral Therapy (ART), staging of the disease and monitoring of HIV-infected patients in middle- and low-volume testing laboratories. Prequalification from the WHO is required in order for a product to be included on the WHO's prequalified list and for international agencies such as the Global Fund and United Nations entities to procure systems.
The WHO report was based on the assessment of product dossier, manufacturing site inspection and laboratory evaluation. According to the report, the BD FACSPresto system has "fulfilled the WHO requirements for prequalification in all three components mentioned above."
CD4 testing allows HIV/AIDS patients to have access to treatment and monitoring, reducing the probability of transmitting the infection to others and providing a plan for improved long-term care. Immediate treatment for infected individuals who meet medical guidelines can dramatically quell the spread of HIV according to the WHO. This is particularly important as many new cases of HIV/AIDS are transmitted from people who are not aware they are infected. [i],[ii]
The BD FACSPresto system is portable, weighs only 6 kg (13.23 lbs.) and can be easily transported. The cartridge uses dried reagents and offers stability across a wide range of storage conditions.
The BD FACSPresto system is CE marked according to the EU IVD Directive 98/79/EC and is available now. The system is priced competitively compared to CD4 systems currently on the market. BD expects pricing for both the counter and reagents to be aligned with expectations of the Clinton Health Access Initiative (CHAI), President's Emergency Plan for AIDS Relief (PEPFAR), The Global Fund, Partnership for Supply Chain Management (PFSCM), and UNICEF. The BD FACSPresto system is not yet available in the U.S.
BD is a leading medical technology company that partners with customers and stakeholders to address many of the world's most pressing and evolving health needs. Our innovative solutions are focused on improving drug delivery, enhancing the diagnosis of infectious diseases and cancers, supporting the management of diabetes and advancing cellular research. We are nearly 30,000 associates in 50 countries who strive to fulfill our purpose of "Helping all people live healthy lives" by advancing the quality, accessibility, safety and affordability of healthcare around the world. For more information, please visit www.bd.com .
[i] AIDS. 2006 Jun 26;20(10):1447-50. Estimating sexual transmission of HIV from persons aware and unaware that they are infected with the virus in the USA . [ii] http://www.cdc.gov/hiv/topics/surveillance/resources/reports/ . [iii] Data on file at BD.
Contact: Abigail Cardona BD Public Relations (201) 847-4605 [email protected]
SOURCE BD (Becton, Dickinson and Company)