SUNNYVALE, Calif., Dec. 1, 2015 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced that it had been named as a supplier of HIV Viral Load and early infant diagnostics by the Global Fund as one of seven diagnostic manufacturers awarded three year pricing agreements intended to broaden accessibility to HIV testing.
"Cepheid is proud to partner with the Global Fund and other organizations working to ensure more patients are aware of their HIV status, have access to sustained antiretroviral therapy, and ultimately achieve viral suppression," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "In order to achieve the ambitious goals established by UNAIDS, we believe that some HIV Viral Load testing must move out of the central laboratory and closer to patient. Portable testing solutions like the GeneXpert® System are critical to ensuring that all patients, regardless of location, have access to the highest quality molecular tests for diagnosis and ongoing monitoring in real-time."
Cepheid's test for HIV Viral Load, Xpert HIV-1 VL, was launched in March 2015 in countries that recognize the CE-IVD mark. The test runs on the GeneXpert System, which also offers molecular tests for tuberculosis, HCV, HPV, Ebola, and for HIV early infant diagnosis, among others. Since Cepheid's High Burden Developing Countries (HBDC) program was launched in 2010, more than 4,000 GeneXpert Systems have been placed globally in 116 low and middle income countries.
"Until very recently, it was not possible to deliver high quality viral load testing in real-time at remote patient settings," said David Persing, M.D., Ph. D., Cepheid's Chief Medical and Technology Officer. "With the GeneXpert Omni, we are building on the decentralization enabled by our current system, and setting a new standard in portability with a battery-operated molecular diagnostics system weighing about one kilo and standing about 23 cm tall."
The GeneXpert Omni will be on display at the 18th International Conference on AIDS and STIs in Africa (ICASA) 2015 in Harare, Zimbabwe, Booth 35 from 30 November to 4 December and 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 the US 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.
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
To date more than 9,200 GeneXpert systems have been deployed globally in both developed and emerging countries. 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 18 tests in the US. More information on the GeneXpert system and the Xpert tests is available on our website at www.cepheidinternational.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 availability, performance, sensitivity, speed, accuracy, diagnostic utility and clinical efficacy of our products, 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 a clinical environment, and the ability of our products to help reduce prevalence of disease and cut future medical treatment costs. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the Company'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 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; 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