USAID And Cepheid Plan Collaboration To Accelerate Global Diagnosis Of Multidrug-Resistant Tuberculosis

SUNNYVALE, Calif., Jan. 7, 2016 /PRNewswire/ -- Cepheid CPHD today announced that it has signed a Memorandum of Understanding (MOU) representing the intention of the company, working with the United States Agency for International Development (USAID), to support the White House's National Action Plan for Combating Multidrug-Resistant Tuberculosis. The National Action Plan identifies critical interventions to be taken by United States Government agencies and partners to reverse the worldwide spread of multidrug-resistant (MDR) tuberculosis (TB). The MOU is expected to be followed by a Collaborative Agreement between Cepheid and USAID setting out the details of this cooperation.

Tuberculosis is the biggest infectious disease killer in the world. Although TB is curable, 1.5 million people died from the disease in 2014 – often as result of delayed diagnosis and incorrect treatment. Inappropriate treatment can also lead to MDR-TB which is resistant to the two most effective anti-TB drugs, and extensively drug-resistant TB (XDR-TB) which is resistant to most anti-TB drugs. Each year, more than 480,000 people will develop MDR-TB, yet fewer than 20% will be diagnosed and started on appropriate treatment. The National Action Plan calls for aggressive interventions to diagnose and treat MDR-TB so that by 2020, 50% of patients with MDR-TB in the countries with the highest burdens will be diagnosed and correctly treated. In order to reach these targets, the National Action Plan will accelerate detection of drug-resistant TB by scaling up proven technologies and supporting continued innovation.

"USAID is proud to partner with Cepheid in the global fight against TB," said Dr. Ariel Pablos-Méndez, USAID Assistant Administrator for Global Health. "As a result of Cepheid's leadership in developing and rolling out innovative TB diagnostic techniques, people with TB or MDR-TB can now get an accurate diagnosis and start taking life-saving medicines within just a few hours, rather than having to wait weeks for their test results. This innovation will dramatically increase our ability to save lives and bring us closer to our goal of creating a TB-free world."

"Since WHO endorsement of the Xpert MTB/RIF test in December of 2010, Cepheid has delivered more than 4,000 GeneXpert Systems and shipped more than 15 million test cartridges to the countries most affected by a treatable condition that continues to cause more than a million deaths each year," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "Cepheid is proud to be a leading innovator in molecular tuberculosis testing, and we look forward to partnering with USAID and others to implement the White House plan. In particular, the introduction of our portable, battery-operated and wireless communication-enabled GeneXpert Omni later this year is expected to enable laboratory-quality molecular diagnostics to be deployed even closer to patients in resource-limited areas. With innovations like these, the global community has the opportunity, for the first time, to coordinate access to precision medicine strategies enabling achievement of the 2020 goals."

About Cepheid

Based in Sunnyvale, Calif., Cepheid 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 9,200 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 19 tests in the US. 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 a potential future collaboration agreement with USAID and the substance, results and effects of the collaboration between Cepheid and USAID, the future availability, performance, technical and product specifications, sensitivity, speed, accuracy, diagnostic utility and clinical efficacy of the GeneXpert Omni and Xpert tests, the White House National Action Plan and achievement of its goals, and the United States Government's TB Strategy and achievement of its goals.  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 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
+1 408-400-8329
corporate.communications@cepheid.com

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SOURCE Cepheid