Promising Early Performance of Cervical Cancer Test Announced

Cepheid has 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 CEO.  “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.”
 
“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, MD, 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.”