Diagnostic tests are essential for the prompt detection of health security threats and to enable an effective response. They range from high-end machines in national level laboratories to simple point-of-care tests at health clinics. Apart from detecting diseases they can also help determine the best treatment, which is important for halting the spread of drug-resistance.
A key problem in the Indo-Pacific is the lack of appropriate diagnostic tests for patients when they first make contact with the health system. There is a market gap for cheap diagnostic tests that are simple, fast, accurate, and are robust enough to function in high temperature and humid environments. This is particularly true for diseases that predominately affect lower and middle-income countries. For example, at the point-of-care level, there is a need for higher-sensitivity tests to detect sub-clinical malaria infections and for tests to rapidly diagnose drug-resistant TB.
Disease elimination efforts will be hampered until the millions of undetected cases per year are found. Improved diagnostics used at scale will assist the Indo-Pacific to achieve this outcome.
How will we address the challenge?
By funding the research and development of more effective diagnostic tests, including for drug-resistant TB and malaria, through Product Development Partnerships (PDPs). PDPs bring together funding agencies, private industry and scientists to develop new drugs, diagnostics and other disease prevention and control technologies for use in poor-country settings where market incentives alone will not drive product development.
Global, with a focus on high-burden TB and malaria countries as defined by WHO and with special attention to key countries in the Indo-Pacific Region.
- The Foundation for Innovative New Diagnostics (FIND) - $18.75 million 2018-2022.
What will success look like?
Indo-Pacific countries using more effective diagnostic tests to reduce the health and economic impacts of TB and malaria.
The Australian Government’s partnership with FIND began in 2015, with the PDP receiving $10 million over three years to 2018. In 2017 an independent review found that DFAT’s investment in PDPs, through core funding, represented good value for money and that FIND’s innovations had made significant contributions to health security in the indo-pacific.
KEY INVESTMENT OUTCOME
GeneXpert® MTB/RIF (Xpert)
The development of the Xpert® MTB/RIF assay (Cepheid, Sunnyvale, USA) was a major step forward for improving the point-of-care or decentralised diagnosis of TB and rifampicin resistance detection globally.
Xpert MTB/ RIF assay is used for rapid, simultaneous detection/diagnosis of Mycobacterium tuberculosis (MTB) and rifampicin resistance in less than two hours. In comparison, standard liquid cultures can take two to six weeks for MTBC to grow and conventional drug resistance tests can add three more weeks. The information provided by the Xpert MTB/RIF assay aids in selecting treatment regimens and reaching infection control decisions quickly. Minimal technical training is required to run the test.
Additionally, the Xpert MTB/RIF assay can quickly identify possible MDR-TB, because rifampicin resistance is a predictor of MDR-TB as rifampicin resistance typically co-exists with Isoniazid (INH) resistance. Rapid diagnosis of rifampicin resistance potentially allows TB patients to start on effective treatment much sooner. Although it received CE Mark in 2009 and was endorsed by the WHO in December of 2010 following 18 months of rigorous field assessments, it was granted marketing authorisation by the FDA in 2013 and also received WHO endorsement for use in paediatric patients, and to detect extra-pulmonary TB (related trials ended in 2014). In February of 2015, the FDA cleared the assay for expanded use to help practitioners determine if patients with suspected TB can be removed from airborne infection isolation. This Ultra cartridge (compatible with the GeneXpert) and developed by Cepheid (Sunnyvale, USA), has shown significantly better performance (increased sensitivity leading to 10-20% more cases diagnosed and treated rapidly) compared to the current Xpert MTB/RIF cartridge in specimens with low numbers of bacilli, especially in smear-negative, culture-positive specimens (e.g. persons with HIV co-infection), in paediatric specimens and in extra-pulmonary specimens (notably cerebrospinal fluid). The accuracy in detection of rifampicin resistance was also better although not enough data were available to confirm this conclusively. Ultra performance approaches that of liquid culture but is faster and easier to use at the point of care . Countries with access to concessional pricing will pay USD 9.98 for the test. Registration and uptake in countries recently kicked off and will be ongoing through 2018. A list of specific countries within the Asia Pacific should be available shortly.