SUNNYVALE, Calif., Feb. 13, 2015 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) for expanded claims on its Xpert® MTB/RIF test. Xpert MTB/RIF detects Mycobacterium tuberculosis complex (MTB-complex) DNA and in positive specimens, provides simultaneous identification of rifampin-resistance associated mutations of the rpoB gene. The expanded product claim enables clinicians to use either one or two negative Xpert MTB/RIF test results, in conjunction with other clinical and laboratory data, to remove patients from airborne infection isolation (AII), commonly referred to as respiratory isolation. 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.
"Xpert MTB/RIF has been heralded as a game-changer with its ability to deliver actionable results in under two hours. This claim expansion significantly extends the diagnostic utility of Xpert MTB/RIF for U.S. hospitals," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "Placing patients in respiratory isolation is expensive for healthcare facilities and can impede patient care."
Despite the continued decline in U.S. TB cases and rates since 1993, the goal of TB elimination in the United States remains unmet. Most states reported fewer cases of TB in 2013. However, elevated rates of TB in specific populations remain a major challenge that impedes progress toward TB elimination. The TB incidence rate among foreign-born persons in 2013 was approximately 13 times greater than the incidence rate among U.S.-born persons, and the proportion of TB cases occurring in foreign-born persons continues to increase, reaching 64.6% in 2013.1
"Although the incidence of tuberculosis in the U.S. is low, due in large part to successful public health strategies, the number of patients being evaluated for possible tuberculosis is still significant," said Dr. David Persing, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "Xpert MTB/RIF returns test results in two hours, allowing clinicians to discontinue airborne infection isolation precautions quickly rather than waiting days or weeks for the return of three negative smear tests. The ability to quickly differentiate patients that require TB respiratory isolation from those that do not pose a risk of transmitting TB will allow hospitals to focus their infection control efforts where they can have the greatest impact."
The Xpert MTB/RIF package instruction sheet with the new expanded claims will available on Cepheid's website beginning Tuesday, February 17th 2015 at the following URL: www.cepheid.com/us/mtbrif-pi. For more information on Cepheid's entire menu of Xpert tests, visit www.cepheid.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.
1. Alami NN, et al. Trends in Tuberculosis — United States, 2013, MMWR Volume 63 / No. 11 March 21, 2014
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, 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 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 clinical 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.
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