Roche has announced the launch of its Amplicor Human Papillomavirus (HPV) test kit in the European Union, an important landmark in the development of its global women’s health portfolio.
The new Amplicor HPV kit with CE marking (“Conformité Européene”) for in-vitro diagnostics is the first PCR-based (polymerase chain reaction) reagent for the detection of HPV. This new test identifies all 13 high-risk genotypes of HPV, which is the leading cause of cervical cancer affecting more than 500,000 women worldwide every year.
“There is a large unmet medical need to enhance diagnosis of cervical cancer through the use of an HPV PCR test,” said Heino von Prondzynski, Head of Roche Diagnostics and Member of the Roche Executive Committee. “The Pap test alone is only about 80 per cent effective in detecting the precursors of cervical cancer. Furthermore, the presence of a cervical precancer is unclear in a significant percentage of ‘inconclusive’ Pap tests. HPV PCR tests can help resolve these inconclusive tests.
Roche Diagnostics is also developing a PCR-based linear array HPV product, based on a proven format used by more than 30 laboratories globally. The linear array identifies 37 HPV genotypes, including all high- and low-risk genotypes in the anogenital region. Potential clinical applications for the linear array HPV product include confirmation of positive screening results, follow-up of positive results, and providing subtype (genotype) information that will assist physicians with choosing the next steps for treatment. Discoveries about HPV and cervical cancer conducted with the aid of Roche’s linear array HPV product have been published in many leading peer-reviewed medical and scientific journals, including “The Lancet” and “Cancer”.