BD and FIND Evaluate New, Low-Cost TB Screening Test and Will Expand Existing Pricing Agreement to Include the Evaluation of New Laboratory Use Reagents
Contact: Jamie Yacco
Franklin Lakes, NJ and Paris, France (November 4, 2013) – BD (Becton, Dickinson and Company), a leading global medical technology company, and FIND (Foundation for Innovative New Diagnostics) today announced a feasibility project that will evaluate the potential use of a low-cost, image-based TB screening platform that is currently in development. This platform provides ease-of-use and semi-quantitative automated results that improve accuracy by standardizing LED microscopy and eliminating associated user subjectivity. This diagnostic advancement has the potential to streamline the detection process and detect more TB cases when compared to conventional microscopy and centralized laboratory molecular diagnostic testing methods.
“There is a need for improved TB detection, particularly at the lowest levels of a health system,” said Renuka Gadde, Vice President, Global Health, BD. “BD’s image-based technology will enable simpler, more accurate detection and will enhance TB detection among HIV-TB co-infected populations where microscopy screening may be inadequate. We believe this new technology will play a key part in reaching the missing millions of patients who currently escape TB diagnosis in health systems.”
Detection of TB in patients can be difficult and often requires repeat testing to confirm the Mycobacterium TB bacteria in a clinical specimen. It is even more difficult to detect TB in patients who have weakened immune systems due to HIV/AIDS. Approximately one-third of the estimated 33 million people living with HIV worldwide are infected with TB, and TB is known as a leading cause of death for persons infected with HIV.1 With TB infection rates rising exponentially in countries that are heavily burdened by HIV/AIDS, it is critical to address the risk of TB co-infection in a timely manner. The new TB screening platform aims to more accurately identify smear negative and otherwise culture positive patients within 10 minutes of running the test.
BD and FIND also announced a collaboration to complete a pricing agreement to provide access to laboratory-use only reagents. These laboratory-use only reagents may be evaluated for potential use by TB laboratories.
BD and FIND are committed to stopping the spread of TB, especially multidrug resistant tuberculosis (MDR-TB). This deadly form of TB is caused by bacteria that do not respond to isoniazid and rifampicin, two of the most powerful first-line, anti-TB drugs. Second-line drugs are only registered for use to treat MDR-TB when there is resistance to first-line therapy. In 2011, the World Health Organization (WHO) estimated 310,000 MDR-TB new cases annually worldwide. The highest proportions of patients with MDR-TB are in Eastern Europe and central Asia. The WHO estimates that although the number of people detected with rapid diagnostics tests is increasing dramatically, three out of four people estimated to have MDR-TB worldwide are still not detected.
“The bad news is that MDR-TB is a public health crisis – the health sector urgently needs rapid, accurate and affordable diagnostics to help detect the disease and to help preserve the effectiveness of the few drugs that really work – the good news is that this new tool has some real potential to do that,” said CatharinaBoehme, Chief Executive Officer of FIND.
BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD'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 nearly 30,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.
The Foundation for Innovative New Diagnosticsis dedicated to developing affordable, easy-to-use, cutting edge diagnostic tests that save lives in the poorest areas of the world. From proof of principle to putting new tests into practice, the organization works with diverse groups, including academia, industry, donors, partners in the field, Ministries of Health and the World Health Organization. With new diagnostics for malaria, tuberculosis and sleeping sickness already in use, FIND is also working on neglected diseases such leishmaniasis, Chagas disease, and other causes of acute fever. Launched in 2003, the not-for-profit Foundation is ISO certified and financed by both the private and public sectors, including the Bill & Melinda Gates Foundation, the governments of the Australia (AusAID), the Netherlands, Germany (BMBF/KfW), the United Kingdom (DFID) and the United States (CDC, NIH and USAID), the European Union, UNITAID, The Global Fund to Fight AIDS, Tuberculosis and Malaria, UBS Optimus Foundation and others.
 WHO Global Tuberculosis Report 2013, http://www.who.int/tb/publications/global_report/en/index.html