SUNNYVALE, Calif., June 15, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced that its Xpert® HIV-1 Qual (Qualitative) test has been awarded World Health Organization (WHO) prequalification, making it one of the first molecular point of care tests designed for HIV to be given this designation. The test can detect HIV-1 in whole blood and dried blood spots from individuals suspected of HIV infection, including infants. Inclusion in the prequalification list signifies that Xpert HIV-1 Qual meets WHO's stringent performance, quality, safety and reliability standards, and fulfills a performance measure established for many developing countries and global health participants before they can allow broad deployment of a new technology.
Without timely HIV testing and therapy initiation, one-third of HIV-infected infants will die before their first birthday, and more than 50% will die before their second birthday.1 Globally, an estimated 110,000 children died of AIDS-related causes in 2015.2 HIV infection in infants can only be diagnosed by molecular testing since immunoassay tests can be ambiguous given the presence of maternal HIV antibodies in the infant's bloodstream up to 18 months of age.3
"Early detection of HIV in infants can be life-saving, particularly if these children are placed on antiretroviral therapy (ART) in the first twelve weeks of life," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "Current central laboratory testing methods are slow, delays in initiation of ART for HIV-positive infants are all too common, and many patients are lost to follow up. In fact, for as many as half the infants tested for HIV, results are never received."4
"Having rapid quantitative results available for assessment of maternal transmission risk on the day of delivery, along with a sensitive qualitative test to determine neonatal infection status, could together represent significant leaps forward in HIV prevention strategies," said Jeanne Jordan, Ph.D., Professor, School of Public Health at The George Washington University.
Xpert HIV-1 Qual is part of a comprehensive portfolio of Xpert tests available internationally, including Xpert HIV-1 VL, Xpert CT/NG, Xpert Ebola and Xpert MTB/RIF, which run on the GeneXpert® System, the world's most prevalent molecular diagnostics platform.
Xpert HIV-1 Qual is available outside the United States. For more information on Cepheid's GeneXpert Systems or the complete 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' system. 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 United States, and 20 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 performance, technical and product specifications, sensitivity, speed, accuracy, diagnostic utility and clinical efficacy of the Xpert HIV-1 Qual (Qualitative) test, the test's ability to enable faster initiation of therapy for HIV infants at the point of care and the impact of the test on HIV prevention strategies. 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.
2 UNAIDS aidsINFO. http://aidsinfo.unaids.org/ |
3 WHO Consolidated Guidelines on HIV Testing Services. July 2015.
For Cepheid Media & Investor Inquiries:
Jacquie Ross, CFA
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