The Centre has partnered with FIND as a Product Development Partnership. 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.
Following the recommendations in the review, the Health Security Initiative in 2018 announced $18.5 million in new funding for FIND over five years under the $75 million Product Development Partnership Fund.
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.