This article has been corrected to state that Roche's test detects 14 high-risk HPV types, rather than 13 as originally reported.
NEW YORK (GenomeWeb News) – Roche today announced it has been awarded an exclusive contract by Karolinska University Hospital to provide its cobas HPV Test as a primary screening tool for human papillomavirus in women in Sweden.
The agreement is the first major public tender in Europe for use of Roche's test to screen women for high-risk HPV types that may lead to cervical cancer, the company said. It added that the screening program, which will start in November, is expected to serve as a pilot program for nationwide implementation of HPV primary screening in Sweden.
The cobas HPV Test is a qualitative in vitro test and uses PCR and nucleic acid hybridization to amplify target DNA to detect 14 high-risk HPV types. Specifically, it identifies types HPV 16 and HPV 18 — the two highest-risk HPV genotypes, responsible for more than 70 percent of cervical cancers cases — as well as other high-risk types.
The test is available in the US and in countries accepting the CE mark and runs on Roche's cobas 4800 system.
According to Roche, guidelines issued by the European Union in 2008 introduced the possibility of using HPV testing as the primary diagnostic test for cervical screening, and Sweden is one of the first nations to follow those guidelines.
Daniel O'Day, COO of Roche Diagnostics, said that the company has shown that in clinical trials 10 percent of women with normal Pap results and with HPV genotype 16 and/or HPV genotype 18 already had pre-cancerous lesions. These women may not receive follow-up care.
"With the introduction of our new HPV test as the primary screening test, we hope to reduce the number of women who are missed in the early stages, and thereby enable earlier intervention before they develop cervical cancer," O'Day said.