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On World TB Day 2015 Cepheid and NHLS Commemorate
Global Shipment of the 10 Millionth Xpert MTB/RIF Test Cartridge
SUNNYVALE, CALIFORNIA —March 24, 2015 — Cepheid (Nasdaq: CPHD) and the National Health Laboratory Service (NHLS) in South Africa today recognized World TB Day 2015 by commemorating the global shipment of the 10 millionth Xpert MTB/RIF cartridge — which was received by Helen Joseph Hospital Laboratory in Johannesburg, South Africa. The Xpert MTB/RIF test runs on Cepheid’s GeneXpert® System, the world’s leading molecular diagnostic platform with over 8,000 systems deployed globally in both developed and emerging market countries.
On World TB Day in 2011, the NHLS announced a national implementation program to place GeneXpert Systems in all laboratories in the nine high-burden districts in South Africa.1 Since the program began more than 300 GeneXpert instruments have been placed in over 200 sites. The National Health Laboratory Service is the largest diagnostic pathology service in South Africa with the responsibility of supporting the national and provincial health departments in the delivery of healthcare.
“The GeneXpert System adds clinical value to the NHLS as it provides a rapid turnaround time, thus increasing reliability and productivity of our organisation. The testimony to this is seen in the total of 5,353,517 specimens which have been processed from the commencement of our programme in March 2011 through February 2015,” said Sebaka Molapo, Project Manager of the National Priority Programmes (NPP). “We are optimistic that GeneXpert technology will help us to achieve the 90– 90–90 target in South Africa set by the National Department of Health (NDoH).”
“Tuberculosis is preventable and curable,” said John Bishop, Cepheid's Chairman and CEO. “Every year on March 24th the global community commemorates the date in 1882 when Dr. Robert Koch astounded the scientific community with his announcement that he had discovered Mycobacterium tuberculosis, the bacillus that causes tuberculosis. World TB Day is designed to build public awareness that tuberculosis remains an epidemic in much of the world. I am proud of the work that Cepheid's employees and partners have done to bring attention to the need for increased awareness of TB to the widest possible audience.”
Cepheid also announced the release of its RemoteXpert cloud-based monitoring software, which allows authorized agencies to view GeneXpert results in real-time for the purpose of tracking and monitoring emerging infections, including drug-resistant tuberculosis. In a pilot phase conducted from 2011-2014, RemoteXpert collected data from nearly 2.5 million TB cases in 3 countries.
“The detection of TB and drug resistance rates by location, in real-time, represents a major advance in the field of digital disease detection,” said Dr. David H. Persing, MD, Ph.D., Cepheid’s Chief Medical and Technology Officer. “We showed that Xpert MTB/RIF data collected from hundreds of systems could be nearly instantaneous, inherently objective, and potentially actionable.”
Current HBDC customers can now receive RemoteXpert connectivity free of charge if they have a service agreement.
Last October Cepheid, FIND, and Rutgers New Jersey Medical School announced details of a collaboration to develop Xpert® MTB/RIF Ultra, a next-generation test for Mycobacterium tuberculosis (TB) with increased sensitivity to aid in detection of patients with smear-negative TB, which is often associated with HIV co-infection.
Cepheid is also developing an additional test to specifically call out extensively drug-resistant (XDR) tuberculosis. XDR TB is a form of multidrug-resistant tuberculosis (MDR TB) that is resistant to the most potent TB drugs — isoniazid, rifampin, aminoglycosides, and any fluoroquinolone.
For more information on Cepheid’s entire menu of Xpert tests, visit www.cepheidinternational.com.
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.
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 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.