CAPE TOWN, South Africa and GENEVA and SUNNYVALE, Calif., Dec. 3, 2015 -- FIND and Cepheid today announced that they are broadening 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. More information on the request for applications (RFA) can be found at www.finddx.org/resource-centre/news/151203.html.
"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 2 to 6 December, 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. FIND also supports better access to new diagnostics through implementation, quality assurance and lab strengthening work. FIND has over 100 partners globally, including research institutes and laboratories, ministries of health and national disease control programmes, commercial partners, bilateral and multilateral organizations, especially WHO, and clinical trial sites. To learn more, visit www.finddiagnostics.org
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, Cepheid's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, Cepheid is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit www.cepheid.com.
About GeneXpert Systems and Xpert Tests
With more than 9,200 systems in 182 countries, the GeneXpert System is the world's most popular molecular diagnostics' instrument. The GeneXpert System's modular configuration means that the system is the most scalable molecular diagnostics' system available, offering the ability to perform from one to eighty Xpert tests at the same time. As a result, the GeneXpert System meets the throughput requirements of customers of all sizes - from lower volume point-of-care settings to higher volume reference laboratories – enabling accurate, fast and cost effective test results.
GeneXpert Systems run proprietary Xpert test cartridges. The Xpert test menu spans healthcare-associated infections, sexual health, critical infectious disease, and oncology, and today offers 23 tests outside the United States, and 18 tests in the United States. More information on the GeneXpert System and the Xpert tests is available on our website at www.cepheid.com.
Forward Looking Statements
This press release contains forward-looking statements that are not purely historical regarding Cepheid's or its management's intentions, beliefs, expectations and strategies for the future, including those relating to the future availability, performance, technical and product specifications, sensitivity, speed, accuracy, diagnostic utility and clinical efficacy of the GeneXpert Omni and Xpert tests, including relative to competing products and technologies, the availability and performance of products currently under development, future medical practice dynamics, including the utilization of our tests in remote areas of the world, and the ability of our products to help reduce prevalence and impact of disease. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from Cepheid's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: test performance in the field, particularly in new environments and remote areas of the world; utilization of our tests by clinicians and future changes in medical practice and protocols; our ability to successfully and timely develop new products; the completion of clinical trials for new products successfully and in a timely manner; uncertainties related to the United States FDA, European and other regulatory processes; Cepheid's ability to successfully introduce and sell products in global markets; Cepheid's research and development budget; unforeseen supply, development and manufacturing problems; Cepheid's ability to manage its inventory levels; Cepheid's ability to successfully complete and bring on additional manufacturing lines; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; Cepheid's reliance on distributors in some regions to market, sell and support its products; the impact of competitive products and pricing; the costs of product components and other factors affecting product pricing; Cepheid's ability to manage geographically-dispersed operations; and underlying regulatory, political and market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K, its most recent Quarterly Report on Form 10-Q, and its other reports filed with the Securities and Exchange Commission.
All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.