New HPV Genotyping Test

The test has received the CE Mark.

The Linear Array HPV genotyping test is the first HPV genotyping test kit registered for in vitro diagnostic use. It was developed by Roche Diagnostics (Basel, Switzerland) and is based on an HPV patent portfolio acquired from the Institut Pasteur in 2002. The test is designed to complement existing HPV screening tests by identifying which HPV genotype is present in a patient sample.

Applications for the test include clinical evaluation of HPV infection and clearance of specific HPV genotypes; monitoring the persistence of high-risk infections; evaluation of the effectiveness of excisional therapy, radiation treatment, and chemotherapy; pre- and post-vaccine evaluation; and furthering epidemiologic studies. The Roche test uses amplification of target DNA by polymerase chain reaction (PCR) and nucleic acid hybridization to detect 37 anogenital high- and low-risk HPV DNA genotypes. Among the 13 HPV genotypes known to be high risk, genotypes 16 and 18 account for more than two-thirds of all cervical cancer cases.

There are more than 100 different genotypes of HPV, and more than 30 different HPV types that can infect the human genital mucosa. The presence of HPV infection has been implicated in more than 99% of cervical cancers worldwide.

"The accurate identification of high-risk HPV genotypes is a major step forward in defining a woman's risk of progression to cervical cancer,” noted Heino von Prondzynski, CEO of Roche Diagnostics. "The Linear Array HPV genotyping test will help physicians determine the best treatment options for their patients.”




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