Cepheid Releases 60-Minute Xpert HPV Test in Europe

Sunnyvale, Calif., diagnostics maker Cepheid is launching its Xpert HPV human papillomavirus test in Europe, following receipt of the CE Mark.

The connection between HPV and cervical cancer is well known, but conventional nucleic acid amplification tests can be complicated, and batch testing can delay results, Cepheid said. This, in turn, can delay time-critical follow-up in patients whose HPV possesses the E6 and E7 oncogenes in any of the 13 high-risk cancer-related virus types. The Xpert HPV focuses on types 16 and 18, which are linked to nearly 71 percent of cervical cancer cases worldwide.

In clinical evaluations comparing it with conventional approaches, Xpert HPV delivered equivalent numbers of true positives and far fewer false positives in women with negative biopsies.

The multiplexed test runs on the company’s GeneXpert molecular diagnostic system, which uses polymerase chain reactions to integrate sample preparation, nucleic acid amplification and detection of the target sequence in simple or complex samples. It comes in one, two, four or 16 modules and returns result in one hour, according to the company.

Cepheid expects Xpert HPV to gain clearance in the U.S. market by 2016 or 2017. The company also makes Xpert tests for MRSA, C. difficile, influenza, mycobacterium tuberculosis, norovirus and a number of other diseases. — Lena Freund

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