FIND, a global non-profit dedicated to accelerating the development, evaluation and delivery of high-quality, affordable diagnostic tests for poverty-related diseases, and leading molecular diagnostics company, Cepheid have broadend their collaboration on bringing point-of-care tuberculosis (TB) diagnosis to all levels of the health system in low and middle-income countries (LMICs).
The work under the collaboration will focus on evaluating and implementing Cepheid's new GeneXpert Omni system and Xpert MTB/RIF Ultra test, in addition to assessing the system's cloud-based connectivity. These efforts will ultimately benefit all stakeholders, as the resulting data and know-how will be made publicly available.
GeneXpert Omni is a portable molecular diagnostics system expected to enable access to accurate, fast and potentially life-saving diagnosis for patients suspected of having TB, HIV, HCV and Ebola in even the most remote areas of the world. Xpert MTB/RIF Ultra is expected to have enhanced sensitivity relative to the current Xpert MTB/RIF assay, which will enable earlier TB diagnosis, particularly for children and HIV co-infected patients, potentially leading to reductions in morbidity and mortality, secondary transmission, and incorrect treatment.
"GeneXpert Omni may be the game-changing mobile, point-of-care molecular diagnostic tool we have been looking for," said Catharina Boehme, FIND CEO.
"Once we have robust evidence of GeneXpert Omni's functioning in settings of intended use, we want to be ready to support implementation in priority countries. Our first priority is to initiate independent evaluations."
FIND invites applications from experienced clinical sites with the capacity to assess the GeneXpert Omni system and Xpert MTB/RIF Ultra as a smear and culture replacement strategy for TB diagnosis, and to evaluate the connectivity elements of the new platform to inform policy decisions.
"Connected point-of-care diagnostics will have a much needed impact in remote and challenging settings in LMICs where access to diagnosis for TB and other diseases is extremely limited," said John Bishop, Cepheid's chairman and chief executive officer.
"With improved performance of Xpert MTB/RIF Ultra and the GeneXpert Omni's unprecedented portability, molecular TB testing can go anywhere, and deliver critical, accurate and fast diagnostic test results to support disease determination, treatment initiation, and improved patient outcomes."
In addition to supporting the independent, RFA-driven impact evaluations of GeneXpert Omni and Xpert MTB/RIF Ultra, the FIND-Cepheid strategic collaborative agreement covers a complete solution for implementing the GeneXpert Omni system, including training, support and implementation of an end-to-end connectivity solution in jointly identified key countries.
"The work done with GeneXpert Omni will pave the way for new implementation strategies for highly sensitive molecular tests and near-patient drug susceptibility testing," added Dr. Boehme.
The GeneXpert Omni will be on display at the 46th Union World Conference on Lung Health in Cape Town, South Africa, Booth 27-28, from December 2-6, 2015. The system is expected to be available outside of the United States for emerging market customers in the first half of 2016. The first priority Xpert tests for the emerging markets are expected to include the newly announced Xpert MTB/RIF Ultra, Xpert MTB/RIF, Xpert HIV-1 Viral Load, Xpert HIV-1 Qual, Xpert HCV Viral Load and Xpert Ebola.
FIND was established in 2003 as a global non-profit dedicated to accelerating the development, evaluation and delivery of high-quality, affordable diagnostic tests for poverty-related diseases, including tuberculosis, malaria, HIV/AIDS, Ebola, sleeping sickness, hepatitis C, leishmaniasis, Chagas disease and Buruli ulcer. Over the last decade, FIND has partnered in the delivery of 11 new diagnostic tools, including six for tuberculosis, and created an enabling environment for countless more through the provision of specimen banks, reagent development and better market visibility.