US National TB Controllers Association And Association Of Public Health Laboratories Issue Guidance For Use Of Xpert MTB/RIF To Support Respiratory Isolation Decisions

SUNNYVALE, Calif., May 18, 2016 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today welcomed publication of new guidance from the US National Tuberculosis Controllers Association (NTCA) and the Association of Public Health Laboratories (APHL) for users of Xpert MTB/RIF to support decision-making on using Airborne Infection Isolation (AII), commonly referred to as respiratory isolation, in healthcare settings.  Cepheid's Xpert MTB/RIF test received FDA clearance for expanded claims relating to respiratory isolation in February 2015, but this is the first formal set of guidelines by NTCA and APHL for users of Xpert MTB/RIF, available at http://www.tbcontrollers.org/resources/airborne-infection-isolation/#.VzDVXKV0wbw. 

Respiratory isolation can be costly and has also been shown, in some cases, to impede the quality of care and patient satisfaction.^1,2 Presently, many patients who are suspected of having active pulmonary Mycobacterium tuberculosis (MTB) infections are placed in respiratory isolation until three respiratory specimens, each collected at least 8 hours apart, are shown to be negative for tuberculosis (TB) using acid-fast smear-microscopy.  In a study recently published by Luetkemeyer, et al. in Clinical Infectious Diseases, a single Xpert MTB/RIF test was shown to have a negative predictive value of 99.7%, while a second Xpert test increased overall negative predictive value to 100%, when compared to acid-fast smear-microscopy, suggesting a role in aiding clinical decisions regarding the use of respiratory isolation.  In the same study, Xpert MTB/RIF identified all cases of mycobacterial culture-confirmed TB, the current gold standard for tuberculosis diagnosis, and identified the majority of cases with rifampin resistance.³ The NTCA and APHL guidance recommends that if the Xpert MTB/RIF assay is used to release patients from airborne infection isolation, that at least two high quality sputa should be tested with this method. The guidance also includes algorithms on the decision making process. 

"Respiratory isolation is costly from the hospital's perspective and unpleasant from the patient's point of view.  Many acute care hospitals in the United States spend millions of dollars each year on respiratory isolation of pulmonary TB suspects who eventually test negative for TB," said David H. Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer.  "The increased sensitivity of Xpert MTB/RIF over traditional acid fast smears can assist healthcare facilities in keeping more patients who do have pulmonary TB in respiratory isolation, thereby preventing transmission, while releasing those who do not need to be there."  

"While Cepheid's Xpert MTB/RIF test is recognized for its transformative role in TB management in the developing world, it is particularly gratifying to see the test recognized as a potentially valuable and cost-effective aid to managing patients suspected of having TB here in the United States," stated  John Bishop, Cepheid's Chairman and Chief Executive Officer.  "NTCA and APHL are to be applauded for these recommendations for Xpert MTB/RIF users, which could allow many patients to be released from unnecessary isolation substantially faster than under the previous protocol.⁴"

"Our study showed that Xpert MTB/RIF can play an important role in the respiratory isolation algorithm, even in lower prevalence settings like the United States," said Anne Luetkemeyer, M.D., lead author of the NIH-funded ATCG study and Associate Professor of HIV, Infectious Disease and Global Health at the University of California, San Francisco.  "For healthcare settings where respiratory isolation is used, NTCA and APHL’s new guidelines can help shorten unnecessary and costly isolation for patients with suspected pulmonary TB, allowing hospital and public health workers to target their infection control efforts on those who do have TB.  Xpert MTB/RIF can also identify many patients who will be missed with initial negative AFB smears, allowing a more prompt tuberculosis diagnosis."

Xpert MTB/RIF is currently available in the United States and in countries accepting CE-mark.  For more information on Cepheid's GeneXpert Systems or the complete menu of Xpert tests, visit www.cepheid.com. 

Note: this version dated 18 May 2016 in an update to a release dated 5 May 2016.

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 GeneXpert Systems and Xpert Tests

With more than 10,000 systems in 182 countries, the GeneXpert System is the world's most popular molecular diagnostics' system.  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 20 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 the future availability, performance, market acceptance, technical and product specifications, sensitivity, speed, accuracy, diagnostic utility and clinical efficacy of the GeneXpert system and Xpert tests, including relative to competing products and technologies, particularly with respect to predicative value and accurate detection of Xpert MTB/RIF and prevention of unnecessary respiratory isolation and antibiotic therapies, and the impact of Xpert MTB/RIF on the efficiency of hospital and public health workers.  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; acceptance and utilization of the Company's tests by clinicians and future changes in medical practice and protocols; improvements in existing or alternative protocols and alternative solutions; the Company's 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, particularly its Xpert MTB/RIF, 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.

¹ Catalano G, Houston SH, Catalano MC, et al. Anxiety and depression in hospitalized patients in resistant organism isolation. South Med J2003; 96:141–5.
² Millman AJ, Dowdy DW, Miller CR, Brownell R, Metcalfe JZ, Cattamanchi A, Davis JL: Rapid molecular testing for TB to guide respiratory isolation in the U.S.: a cost-benefit analysis. PLoS One. 2013, 8 (11): e79669-10.1371
³ Luetkemeyer et al., Evaluation of Xpert MTB/RIF Versus AFB Smear and Culture to Identify Pulmonary Tuberculosis in Patients With Suspected Tuberculosis From Low and Higher Prevalence Settings. Clin Infect Dis. 2016 Feb 2. pii: ciw035. [Epub ahead of print]
⁴ Davis JL, Kawamura M, Chaisson LH, et al. Impact of GeneXpert Mtb/Rif on Patients and Tuberculosis Programs in a Low-Burden Setting. Am J Resp Care Med. 2014. 189:1551-59.

For Cepheid Media & Investor Inquiries:
Jacquie Ross, CFA
+1 408-400-8329
[email protected]

SOURCE Cepheid

Related Links

http://www.cepheid.com