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World's most portable molecular diagnostics system unveiled at AACC

  • GeneXpert Omni to further decentralize critical TB, virology and Ebola tests

Sunnyvale, California & Geneva, Switzerland — July 28, 2015 — Cepheid (Nasdaq: CPHD) and FIND today unveiled the GeneXpert® Omni, the world’s most portable molecular diagnostics system enabling unprecedented access to accurate, fast and potentially life-saving diagnosis for patients suspected of having TB, HIV and Ebola in even the most remote areas of the world.

At just 9 inches tall (less than 23 cm) and weighing just 2.2 pounds (just under 1 kg), the GeneXpert Omni will run the same high-quality PCR-based cartridge tests as Cepheid’s family of GeneXpert systems. Additionally, the GeneXpert Omni is battery-operated, wireless and web-enabled, setting a new standard in connectivity to transmit instrument and test information in real-time. The GeneXpert Omni is expected to substantially extend the reach of Cepheid’s industry-leading technology platform, enabling true point-of-care testing for life-threatening conditions, including tuberculosis, drug-resistant tuberculosis, HIV and Ebola, to be conducted on-demand at the patient’s location.

“For too long, access to best-in-class molecular diagnostics has been limited by the complexity of the tests and the systems that run them,” said John Bishop, Cepheid’s Chairman and Chief Executive Officer. “With the GeneXpert Omni, global accessibility to molecular diagnostics is possible for the first time. The system’s unprecedented portability means that it can literally go anywhere, and deliver critical diagnostic test results to support disease determination, treatment, and improved patient outcomes.”

In partnership with not-for-profit organizations, Cepheid has been leading efforts to broaden access to quality molecular diagnostics with Xpert® MTB/RIF, a test that was endorsed by the World Health Organization in December 2010. Since then, Cepheid has placed more than 4,000 GeneXpert systems and shipped more than 13 million Xpert MTB/RIF tests as part of its High Burden Developing Country (HBDC) program. The development and initial roll out of Xpert MTB/RIF received essential early support from FIND, the Bill & Melinda Gates Foundation, the U.S. National Institutes of Health, the U.S. Agency for International Development and UNITAID.

“The majority of people in the developing world still lack access to adequate tests for common diseases, and Cepheid’s GeneXpert Omni has the potential to be a breakthrough platform on the path to achieving universal diagnosis,” said Dr Catharina Boehme, Chief Executive Officer of FIND. “Cepheid and FIND share a commitment to enabling universal access to high quality diagnostics for people in the developing world, dating back to 2006 with the Xpert diagnostic test for MTB/RIF, followed by Xpert HIV and, most recently, the next-generation Xpert MTB Ultra. These innovations show the power of collaboration to positively impact public health and patient lives in developing countries.”

“This new point-of-care diagnostic platform has the potential to transform our capacity to detect the world’s missing 3 million TB cases,” said Dr Mario Raviglione, Director of the WHO Global TB Programme. “Innovation in TB research and development is a critical pillar of WHO’s End TB strategy. This ground-breaking, battery-operated technology, which can be used in microscopy centres with limited electrical supply, may bring us one step closer to ending the TB epidemic by 2035.”

The GeneXpert Omni is on display at the American Association of Clinical Chemistry (AACC) meeting in Atlanta, Georgia, Booth 3421, from 28 to 30 July, 2015. The system is expected to be available for emerging market customers in early 2016. At or near launch, the available test menu is expected to include Xpert MTB Ultra, Xpert HIV Qualitative, Xpert HIV Viral Load, Xpert HCV Viral Load, and Xpert Ebola.

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.

About GeneXpert Systems and Xpert Tests
With more than 8,900 systems in 182 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 17 tests in the US. More information on the GeneXpert system and the Xpert tests is available on our website at www.cepheid.com.
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 & Investor Inquiries: For FIND Media Inquiries:
Jacquie Ross, CFA
+1 408-400-8329
investor.relations@cepheid.com		 Julie Archer, Senior Communications Officer
+41 79 830 63 64
julie.archer@finddx.org