Cepheid and FIND announce European approval of Xpert HIV-1 Qual

  • Qualitative 90-Minute test enables early HIV detection in high-risk and pediatric patients

Sunnyvale, California & Geneva, Switzerland — April 16, 2015 — Cepheid (Nasdaq: CPHD) and FIND today announced that Xpert® HIV-1 Qual, a qualitative 90-minute molecular HIV test, has 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 8,000 systems deployed globally in both developed and emerging market countries.

The World Health Organization estimates that 35 million people worldwide are currently living with HIV/AIDS.(1) Of those infected, 2.3 million represent new infections and an estimated 260,000 are children.(2) 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 reaching two years of age.(3)

“Xpert HIV-1 Qual adds to Cepheid’s virology test menu, which already includes Xpert HIV-1 Viral Load and Xpert HCV Viral Load, extending our menu of Xpert tests to 22 outside of the U.S.,” said John Bishop, Cepheid’s Chairman and Chief Executive Officer. “Our GeneXpert System and Xpert tests remain at the forefront of molecular diagnostic innovation, empowering clinicians worldwide with low- or high-volume results that optimize patient outcomes with sample in, answer out simplicity.”

“The modular design of the GeneXpert System means that a point-of-care health clinic can run the exact same cartridge-based test as a national reference laboratory,” said Dr. Appolinaire Tiam, MBChB, DipHIVMan, MMed. Country Director for Elizabeth Glaser Pediatric AIDS Foundation/Lesotho. “This is a unique and powerful tool that will help us provide timely and actionable diagnostics for HIV-infected infants without compromising accuracy of results.”

“FIND’s goal is to make universal access to high-quality diagnostics a reality for people in the developing world,” said Dr. Catharina Boehme, Chief Executive Officer of FIND. “A test that can deliver early diagnosis of HIV infection in high-risk patients and infants, and can also be run on diagnostic systems that are already in use for TB diagnosis has the potential to transform the way the two diseases are managed.”

“While early diagnosis of HIV infection in high-risk patients and infants is critical, significant percentages of patients become lost to clinician follow-up,” said Dr. David H. Persing, MD, Ph.D., Cepheid’s Chief Medical and Technology Officer. “Xpert HIV-1 Qual delivers the highly sensitive, on-demand results needed for same-day diagnosis — the first critical step in saving lives.”

Developed in collaboration with FIND, Xpert HIV-1 Qual begins shipping this month as a CE-IVD Mark product. For more information on Cepheid’s GeneXpert Systems or the complete menu of CE-IVD 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 diagnostic tests for diseases of poverty, including tuberculosis, malaria, HIV/AIDS, 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 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 over 100 partners, including research institutes and laboratories, ministries of health, commercial partners, bilateral and multilateral organizations, especially WHO, and clinical trial sites.

References

1) WHO. HIV/AIDS Fact sheet N°360. Updated November 2014.

2) Joint United Nations Programme on HIV/AIDS (UNAIDS). The Gap Report. (English original, July 2014, updated September 2014). http://www.unaids.org/en/resources/ campaigns/2014gapreport. Accessed February 3, 2015.

3) UNAIDS. Gap Report. UNAIDS / JC2656 (English original, July 2014, updated September 2014) ISBN 978-92-9253-062-4 Copyright © 2014. Joint United Nations Programme on HIV/AIDS (UNAIDS).

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.

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For Cepheid media enquiries: For Cepheid investor enquiries: For FIND media enquiries:
Jared Tipton
Cepheid Corporate Communications
+1 408-400-8377
communications@cepheid.com
Jacquie Ross, CFA
Cepheid Investor Relations
+1 408-400-8329
investor.relations@cepheid.com
Ranald Sutherland
Technology & Business Development
+41 79 273 2482
Ranald.Sutherland@finddx.org