Building on the success of the GeneXpert System and the Xpert® MTB/RIF test, Cepheid is developing the GeneXpert Omni, a portable, battery-operated, and cloud-enabled molecular testing device that will enable sophisticated molecular diagnostic tests to be conducted in even the most remote locations. The company is also developing Xpert MTB/RIF Ultra, a next generation tuberculosis test that is targeting performance standards equivalent to liquid culture.
"We believe that Xpert MTB/RIF Ultra will establish a new benchmark for TB diagnostics," said Dr. David H. Persing, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "In collaboration with FIND and Dr. David Alland at the Rutgers New Jersey Medical School, we completely re-designed the assay to boost sensitivity and specificity, and have reduced the time to result by as much as 40 minutes. The expected increase in sensitivity could render culture confirmation of negative results unnecessary in many parts of the world, while the shorter test run-time will enable even more tests to be run on existing systems."
Tuberculosis can be particularly dangerous for patients co-infected with HIV, so it may be important to test patients for both diseases simultaneously. Among 23 tests available for the GeneXpert System outside the United States, Cepheid now offers Xpert HIV-1 Qualitative and Xpert HIV-1 Viral Load tests.
For more information on Cepheid's entire menu of Xpert tests, visit www.cepheidinternational.com.
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) 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, the company'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, the company 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 10,000 systems in 182 countries, including more than 5,000 in High Burden Developing 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 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 US, and 20 tests in the US. 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 future availability, performance, technical and product specifications, sensitivity, speed, accuracy, diagnostic utility and clinical efficacy of the GeneXpert Omni, Xpert MTB/RIF Ultra and other tests, including relative to competing products, tests and technologies. 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; utilization of the Company's tests by clinicians and future changes in medical practice and protocols; the Company's 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; the Company's ability to successfully introduce and sell products in global markets; the Company's research and development budget; unforeseen supply, development and manufacturing problems; the potential need for additional intellectual property licenses for tests and other products and the terms of such licenses; the impact of competitive products and pricing; the costs of product components and other factors affecting product pricing; the Company'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.
For Cepheid Media & Investor Inquiries:
Jacquie Ross, CFA
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