SUNNYVALE, Calif., Nov. 14, 2013 /PRNewswire/ -- At its Corporate Workshop at the Association of Molecular Pathology (AMP) meeting in Phoenix yesterday, Cepheid shared early performance data for its test for cervical cancer-related human papillomaviruses, Xpert® HPV, which is currently in clinical trials with a targeted CE-IVD release in early 2014.
"We're pleased with the early Xpert HPV data that highlight Cepheid's commitment to delivering tests that offer the unmatched combination of performance, ease-of-use and speed that our customers expect of the Xpert brand," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "This test is a another important milestone in the extension of the Xpert test menu available outside the United States, which extends meaningfully in 2014 to include not just HPV, but HIV and HCV, in addition to a number of other products."
"Highlighting Cepheid's history of innovation, the GeneXpert® System defined – and delivers today - the 'sample-in, answer-out' molecular testing solution that defines the essential capability for broad market dissemination that many others are aspiring to bring to market," continued Bishop. "Our GeneXpert System now has an installed base of more than 5,000 systems in 139 countries, with a menu of 14 available Xpert tests spanning Healthcare Associated Infections, Critical Infectious Disease and Sexual Health. Looking forward, Cepheid's focus is on further extension of our installed base and Xpert test menu, and of course, to further enhancements in our GeneXpert System to ensure we are able to maintain our market leadership in the years ahead."
Xpert HPV is a multiplexed test that targets the E6/E7 region of 14 cancer-related HPV types and specifically calls out types 16 and 18/45 in separate detection channels, with 11 other high-risk types detected in combined channels.
"Consistent with our expectations, the clinical trial data to date suggest that Xpert HPV performs as well as the market leading assays, but in a format that is unprecedented in its ease of use and time-to-result," said David Persing, M.D., PhD, Cepheid's Chief Medical and Technology Officer. "The test incorporates several new design features that we believe position it well for medical practice dynamics of the future given the potential growing importance of HPV type 45 in clinical diagnosis."
The Company's presentation, given by Philip Castle, Ph.D., MPH, Executive Director of the Global Cancer Initiative and Executive Director of the Global Coalition Against Cervical Cancer, is available for download at 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 access the full power of molecular diagnostics. The company's systems enable rapid, sophisticated testing solutions for infectious diseases, oncology, and genetic conditions by automating otherwise complex manual laboratory procedures. 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.
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