Cepheid and the global non-profit FIND recently announced that they are broadening their collaboration on bringing point-of-care tuberculosis (TB) diagnosis to all levels of the health system.
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. 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 to 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 is inviting applications from experienced clinical sites with the capacity to assess the system as a smear and culture replacement strategy for TB diagnosis, and to evaluate the connectivity elements of the new platform to inform policy decisions.
“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,” said John Bishop, Cepheid’s Chairman and Chief Executive Officer.
The FIND-Cepheid strategic collaborative agreement additionally 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.