Cepheid announced the publication of a validation study assessing the use of Xpert HPV (Human Papillomavirus) as a front-line cervical screening test in certain countries outside the United States.
“Performance of a cartridge based assay for the detection of clinically significant HPV infection - lessons from VALGENT (Validation of HPV Genotyping Tests)" has been published on the Journal of Clinical Microbiology website, concluding that "the clinical performance and reproducibility of Xpert is comparable to well established HPV assays and fulfills the criteria for use in primary cervical cancer screening."
"In two years, we have seen at least four European countries - including England just last week - initiate plans to move to front-line HPV testing as a screen for cervical cancer," said John Bishop, Cepheid's chairman and chief executive officer. "As shown in large European studies, HPV as a front-line screening test is demonstrably more effective than cytology in identifying women at risk for cervical pre-cancer or cancer, and Cepheid is very pleased to be extending the options available to ensure that as many women as possible have access to this important screening test."
In the published paper, Cuschieri et al. reported performance of Xpert HPV compared to GP5+/6+ EIA and the Hybrid Capture 2 HPV Test in an aggregated data set with a relative sensitivity for CIN2+ of 0.984 and relative specificity for =CIN1 of 1.006. Intra-lab reproducibility was reported at 96.9%, and inter-lab reproducibility was 97.8%. Xpert HPV comfortably met the requirements established in international guidelines for primary screening tests, commonly referred to as the Meijer protocol.
"Xpert HPV has performance highly comparable to established and validated assays, and can now be added to the list of tests validated for primary cervical cancer screening," said Jack Cuzick, Ph.D., FRS, head of the Centre for Cancer Prevention. "It is an easy to use test that reports individual high risk HPV results in less than one hour."
HPV infection is the most common sexually transmitted infection in the world. A handful of HPV genotypes, known as high-risk HPV (hrHPV), can present severe health risks. hrHPV has been linked to more than 99% of cervical cancers worldwide. Xpert HPV detects 14 types of hrHPV DNA, with specific call-outs for HPV 16 and HPV 18/45. The test can be done completely on site and provides results in less than an hour.