Developing and Standardizing Human Papillomavirus Tests

Abstract Establishment of routine testing for human papillomavirus had a very long and tortuous diagnostic development path, spanning more than 40 yearsfrom initial characterization of the first HPV types to widespread clinical use. The HPV success story was the work product of many differentinvestigators and required numerous seminal discoveries, one of which deserved the Nobel Prize in Medicine. Initial studies of the virus by electronmicroscopy and immunochemistry led to cloning of the HPV types and to early well-performing but complicated HPV DNA tests. Almost 70 differentHPV genomes had to be cloned before we arrived at the final set of HPV probes for cervical cancer screening. The newer HPV DNA tests employsignal and target amplification and their performance is so good that they are revolutionizing cervical cancer screening programs worldwide.