Cepheid and FIND Announce European Approval of Xpert HIV-1 Viral Load

SUNNYVALE, Calif. and GENEVA, Dec. 29, 2014 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) and the Foundation for Innovative New Diagnostics (FIND) today announced that Xpert^® HIV-1 Viral Load, a quantitative test for measurement of the HIV-1 viral load in plasma, has a achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices. The test runs on the Cepheid GeneXpert^® System, the world's leading molecular diagnostic platform with over 7,500 systems deployed globally in both developed and emerging market countries.

Human Immunodeficiency Virus (HIV) is the microorganism that causes Acquired Immunodeficiency Syndrome (AIDS). HIV viral load refers to the quantitative measurement of the amount of active HIV in the blood of someone who is HIV-positive. This measurement has been established as the standard of care in assessing HIV-positive patient prognosis and response to antiretroviral therapy. The measurement is also commonly used for transmission risk assessment during accidental exposure to blood and at-risk exposure in general.

"Xpert HIV-1 Viral Load, our eighth product release in 2014, marks Cepheid's entry into the foundational elements of the virology market and extends our menu of Xpert tests to 20 outside of the U.S.," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "Cepheid's GeneXpert System and Xpert tests remain at the forefront of innovation in the field of molecular diagnostics — delivering the power of on-demand molecular testing to virtually any location worldwide."

The World Health Organization estimates that 35 million people worldwide are currently living with HIV/AIDS¹. People living with HIV are from 26-31 times more likely to develop tuberculosis (TB) than those without HIV. TB is the most common presenting illness among people living with HIV, including those taking antiretroviral treatment, and it is the major cause of HIV-related death².

"Given the challenges presented by HIV and TB co-infection, we believe that Xpert HIV-1 Viral Load will be an excellent addition to Xpert MTB/RIF, dramatically improving endemic countries' capacity to diagnose and manage these infections," said Dr. Catharina Boehme, Chief Executive Officer of FIND. "Our goal is to make quality diagnostics a reality for people in the developing world. An HIV viral load test which can be run on the same system as the WHO-recommended Xpert MTB/RIF has the potential to transform the way the two diseases are managed, and perhaps act as a catalyst to ensure a much more holistic approach to TB/HIV co-infections."

The goal of HIV treatment is to suppress replication of the virus and bring the HIV viral load measurement as low as possible. People with higher viral loads have a greater risk for immune system damage, which increases the risk of opportunistic infections.

"Xpert HIV-1 Viral Load is the first commercially available test designed around exclusive targeting of the most conserved element of the HIV viral genome, the Long Terminal Repeat (LTR)," said Dr. David Persing, MD, Ph.D., Cepheid's Chief Medical and Technology officer. "By employing Cepheid-proprietary special chemistries, LTR-specific reagents and novel control strategies, we were able to develop a next-generation HIV test that is arguably best-in-class with respect to analytical sensitivity and HIV strain coverage."

Xpert HIV-1 Viral Load is expected to begin shipping in February 2015. For more information on the entire CE-IVD menu of Xpert tests, visit www.cepheidinternational.com.

About Cepheid
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 FIND
Founded in 2003, FIND is an international non-profit organization that enables the development and delivery of much-needed diagnostic tests for diseases of poverty, including tuberculosis, malaria, sleeping sickness, hepatitis C, leishmaniasis and Chagas disease.  FIND acts as a bridge between diverse expert groups to address barriers to innovation and implementation of comprehensive and tailor-made diagnostic solutions in low-resource settings. FIND maximizes the impact of diagnostics: access to accurate treatment, disease control and eradication, efficient health care spending and empowered individuals, communities and countries. Over the last 11 years, FIND led the delivery of 11 new diagnostic tools and created an enabling environment for countless more through specimen banks, reagent development and better market visibility. FIND has also supported the scale-up of diagnostics through implementation, quality assurance and lab strengthening work. FIND has active collaborations with over 100 partners, including research institutes/academia, ministries of health, commercial partners, bilateral and multilateral organizations, especially WHO, and clinical trial sites. Learn more about FIND at www.finddx.org.

References

1.       http://www.who.int/gho/hiv/en/

2.       http://www.who.int/tb/challenges/hiv/en/

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, pricing, accuracy and clinical efficacy of our products, including relative to competing products and technologies, the breadth and speed of test menu expansion, the results of clinical trials, future medical practice dynamics, including the utilization of our tests in a clinical environment, and the ability of our products to 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; 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 clinical markets; the Company's research and development budget; the availability of foundation and governmental funding; 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.

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SOURCE Cepheid; FIND

Related Links

http://www.cepheid.com