An extensive study has confirmed the accuracy of Roche's Cobas 4800 Human Papillomavirus (HPV) test, which detects pre-cancerous cells missed by existing screening methods such as cervical smears.
More than 47,000 women participated in the ATHENA HPV Diagnostics trial, which demonstrated that the Cobas 4800 Human Papillomavirus (HPV) test from Roche is able to improve the detection of pre-cancerous cells in women whose cervical smears tested normal.
It was demonstrated that more than one in 10 women in the trial aged 30 years and older who tested positive for HPV genotypes 16 and/or 18 by the Cobas 4800 HPV test had cervical pre-cancer, although their Pap smear was normal.
The conclusion was that genotypes 16 and 18, if tested positive, were high-risk indicators of cervical cancer.
The data points to how important genotyping is to increasing the accuracy of assessing cervical cancer risk, especially screening for the two high-risk HPV genotypes 16 and 18, and underscores the limitations of relying on examining and assessing the appearance of cervical cells under a microscope, as is the traditional method.
Findings from the ATHENA clinical trial also showed that women who tested positive for HPV 16 and/or 18 with the Cobas 4800 HPV test and who had a normal Pap smear test were at the same risk of having cervical pre-cancer as women who tested positive for any of the 14 high-risk HPV types with an equivocal smear.
