Medical News Today -- The largest ever registrational study for a diagnostic product, involving more than 47,000 women shows that the cobas(R) 4800 Human Papillomavirus (HPV) test from Roche, is able to improve the detection of pre-cancerous cells in women whose cervical smears tested normal. The ATHENA (Addressing THE Need for Advanced) HPV Diagnostics trial demonstrated that more than 1 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 Pap1 smear was normal. The conclusion is that genotypes 16 and 18 if tested positive are high-risk indicators of cervical cancer. The data points to the importance of genotyping to increase the accuracy of assessing the risk of cervical cancer, 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.
