New, more accurate cervical cancer test set to save lives

New, more accurate cervical cancer test set to save lives.

More than 47,000 women in the United Kingdom have taken part in a study which shows that the cobas 4800 Human Papillomavirus (HPV) test from Roche, can 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 one in ten 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.

Cervical cancer causes approximately 1,000 deaths each year in the United Kingdom. The current system of cervical cancer screening, introduced across the National Health Service in the late 1980s, is aimed at women aged 20 to 65 years. Women are invited to attend screening every 3 or 5 years depending on age and the system operates on a recall basis if the smear appears abnormal. Persistent HPV infection can lead to the development of pre-cancerous and cancerous cells in the cervix.

The new cobas 4800 HPV test from Roche can provide early detection of pre-cancerous changes in the cervix reducing the risk of cervical cancer and thus has the potential to save lives.

“The ATHENA data shows that women who test positive for HPV 16 and/or 18 should be directly referred for closer examination of the cervix by colposcopy,” said Dr. Thomas C. Wright Jr., M.D. of Columbia University, New York. “Screening for high-risk HPV genotypes provides important additive information to Pap testing, and screening for the two highest risk types, HPV 16 and 18, should be included to provide predictive information about a woman’s risk of having cervical pre-cancer or cancer.”

Findings from the ATHENA clinical trial, also show that women who tested positive for HPV 16 and/or 18 with the cobas(R) 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. The latter clinical situation is broadly accepted to carry a risk of pre-cancer that warrants immediate investigation, underscoring again the importance of testing for HPV genotypes 16 and 18 in women with normal Pap smears.

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