Cepheid Announces Expansion Of The Most Comprehensive Molecular C. Difficile Product Portfolio On The Market
Binary Toxin Gene Reporting has Been Added to the Market Leading Xpert C. difficile Product
Sep 15, 2016, 04:05 ET
SUNNYVALE, Calif., Sept. 15, 2016 /PRNewswire/ -- Particularly perilous Clostridium difficile strains are now potentially easier to detect, thanks to expanded reporting of binary toxin (CDT) gene presence with the leading molecular test for C. difficile from Cepheid (Nasdaq: CPHD).
The presence of binary toxin-producing C. difficile has been linked to increased disease severity, mortality and disease recurrence.1,2 In addition, strains of C. difficile have been documented that appear to cause disease when they are negative for the well known toxins A and B but positive for binary toxin.3,4 With the addition of Xpert C. difficile BT, Cepheid continues to offer one of the most comprehensive molecular C. difficile test portfolios on the market.
"Binary toxin (CDT) is associated with more severe C. difficile infection (CDI)," says Thomas V. Riley, Ph.D. and Microbiology Professor at The University of Western Australia. "In addition, CDT has been linked to an increase in the prevalence of community-acquired CDI, a high rate of recurrent CDI, and the need for hospital admission due to reinfection3. The detection of strains of C. difficile with the ability to produce CDT will provide valuable prognostic information."
"Recent studies indicate that some patients with suspected C. difficile harbor binary toxin producing strains that do not carry the genes for toxins A and B4," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "While the clinical significance of such strains is not yet fully understood, the vast majority of current C. difficile tests will miss these cases completely. Xpert C. difficile BT reports binary toxin status independently, which allows for detection of a wider range of hypervirulent strains and tracking of novel variants that are negative for toxins A and B."
C. difficile infection is the result of C. difficile bacteria overgrowth, commonly caused through exposure to antibiotics for treatments of other illnesses. Binary toxin is produced by a number of C. difficile strains, including PCR-ribotype 027 (Nap1/BI) and other strains associated with severe outcomes.
Xpert C. difficile BT is Cepheid's current Xpert C. difficile test, with modified result reporting that makes the additional information on the presence of binary toxin available. Xpert C. difficile BT is available immediately in countries accepting the CE-mark.
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 11,000 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 performance, technical and product specifications, sensitivity, accuracy, diagnostic utility and clinical efficacy of the Xpert C. difficile test, the ability to recognize strains of C. difficile, and assist with our understanding of C. difficile, and the impact of detection of binary toxin (CDT) in improving prognosis of severe C. difficile infections. 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 the Company's tests by clinicians and future changes in medical practice and protocols; the correct association of binary toxin (CDT) with severe C. difficile infections; the performance of gene differentiation software involved with the tests; 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 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 Bacci et al, 2011. Emerg Infect Dis. Jun; 17(6):976-82
2 Stewart et al 2013. J Gastrointest Surg. 17:118–125
3 Androga et al JCM 2015; 53: 973-5.
4 Eckert, et al. New Microbes New Infect. 2014:8;(3):12-7
For Cepheid Media & Investor Inquiries:
Jacquie Ross, CFA
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