CAPE TOWN, South Africa, November 5 /PRNewswire/ --
- Response to recommendations by WHO for use of TB liquid culture in low- income settings
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and FIND (Foundation for Innovative New Diagnostics), a non-profit product development partnership, today announced a new pricing agreement for the BD BACTEC(TM) MGIT(TM) 960 system and reagents for 39 high- burden, low-income countries, as defined by the World Health Organization (WHO). The BD BACTEC MGIT 960 system uses liquid culture, which can dramatically shorten mycobacterial culture recovery time and improve patient management. This is especially important when treating drug-resistant strains of Mycobacterium tuberculosis (TB).
The FIND/BD negotiated price for the public health sector in these countries is significantly lower than prices commonly paid in industrialized countries and is an additional commitment to the ongoing FIND and BD contributions and investments in demonstration studies and laboratory support.
This pricing agreement announcement is being made in response to the recommendations recently posted by the WHO for the use of mycobacterial liquid culture and drug susceptibility testing (DST) in low and middle-income countries. The WHO endorsed liquid culture systems as the standard of care for TB diagnosis and patient management following FIND demonstration studies on MGIT culture and DST in eight countries. These recommendations are part of the WHO strategy for addressing the emergence of extensively drug-resistant tuberculosis (XDR-TB).
"Drug-resistant tuberculosis continues to pose a serious threat to many countries in the developing world," said FIND Chief Executive Officer, Dr. Giorgio Roscigno. "We applaud the WHO for their important recommendations to address this healthcare crisis. The pricing agreement with BD is an important milestone in our longstanding relationship."
"At BD, we have the potential to have a profound impact on the diagnosis and treatment of TB patients in the developing world, including those co-infected with HIV," said Krista Thompson, Vice President and General Manager, Global Health, BD. "This pricing agreement is part of BD's commitment to make our technologies and expertise available on an affordable and sustainable basis."
About Liquid Culture
Laboratory diagnosis of TB largely relies on the direct microscopic examination of sputum specimens. However, the technique has low and variable sensitivity and cannot identify drug-resistant strains. Mycobacterial culture is more sensitive but growth of TB bacilli on traditional solid media typically requires two to four weeks and as many as eight weeks of incubation. This consequently delays appropriate treatment in the absence of a confirmed diagnosis.
Liquid culture systems reduce the delays in obtaining results by one to two weeks over solid media. For DST, the interval may be reduced to as little as ten days, compared with 28 to 42 days with conventional solid media. Liquid systems are more sensitive for detection of mycobacteria and may increase the case yield by 10% over solid media. With increased sensitivity and reduced delays, liquid systems may contribute significantly to improved patient management.
Expanding culture capacity is urgently needed to address challenges due to the epidemics of HIV-associated TB and drug-resistant TB, especially in resource-limited settings.
According to the WHO, one in three people in the world is infected with dormant TB germs (i.e., TB bacteria). Only when the bacteria become active do people become ill with tuberculosis. Bacteria can become active as a result of anything that reduces the person's immunity, such as HIV, advancing age, or specific medical conditions. TB can usually be treated with a course of four standard, or first-line, anti-TB drugs. If these drugs are misused or mismanaged, multidrug-resistant (MDR) TB can develop. MDR-TB takes longer to treat with second-line drugs, which are more expensive and have more side-effects. XDR-TB can develop when these second-line drugs are also misused or mismanaged and therefore become ineffective. XDR-TB is defined as strains which are resistant to two of the most powerful front-line drugs, as well as at least two key classes of second-line drugs. Because XDR-TB is resistant to many of the first- and second-line drugs, it is a virtually untreatable form of TB.
The Foundation for Innovative New Diagnostics (FIND) is a non-profit organization based in Geneva, Switzerland. Its purpose is to support and promote the health of people in developing countries by sponsoring the development and introduction of new but affordable diagnostic tools for poverty related diseases. FIND's current disease programs include tuberculosis, malaria and human African trypanosomiasis. FIND is ISO 9001 and ISO 13485 certified. For more information please visit: www.finddiagnostics.org
BD, a leading global medical technology company that manufactures and sells medical devices, instrument systems and reagents, is dedicated to improving people's health throughout the world. BD is focused on improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. The Company's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 28,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. For more information, please visit www.bd.com.