"We believe that primary HPV testing has potential to further reduce cervical cancer in the US," Dr. Huh says.
Following an application to the Food and Drug Administration (FDA) for a human papillomavirus (HPV) test to be used for primary HPV-cervical cancer screening, a panel was convened to provide guidance, the findings of which are reported in the first paper.
Consisting of experts from all major organizations in the US involved in cervical cancer screening, the panel assessed the safety and effectiveness of HPV testing based on a literature review and data from the Addressing the Need for Advanced HPV Diagnostics (ATHENA) study, commissioned to support the FDA application.
Study author Dr. Warner Huh, from the Department of Gynecologic Oncology at the University of Alabama in Birmingham, says of the panel's findings:
"We found that, in patients aged 25 years and upwards, primary HPV testing performed better than a Pap alone, and we recommend that such tests should be carried out no sooner than every 3 years. This is an important advance in cervical cancer screening because it offers a better reassurance of low cancer risk compared to Pap screening, which is also carried out at 3-year intervals."
Two HPV genotypes are responsible for about 70% of all invasive cervical cancers. Patients who test positive for either of these genotypes should receive an immediate colposcopy, recommend the panel.
There are another 12 HPV genotypes. The panel suggests that if women test positive for any of these other genotypes, they should be followed up with a repeat of both the HPV test and a Pap in 12 months.
Some countries, such as Australia and the Netherlands, already use primary HPV screening, and Dr. Huh says he would like to see more evidence from these countries on the test's safety and effectiveness in this context.
"But in the absence of data to the contrary," Dr. Huh says, "we believe that primary HPV testing has potential to further reduce cervical cancer in the US."
The ATHENA trial
The second paper published in the journal examines end-of-study results from the ATHENA trial. In the study, 42,209 women aged 25 and older had both Pap and HPV testing and the results were compared. The researchers also examined data on the impact of starting HPV screening at different ages.
The authors found that the HPV test identified about twice as many serious cases of cervical disease in the 25-29 age group as the Pap did.
In other age groups, HPV, Pap and co-testing were found to be equally as effective. However, the researchers point out that HPV screening alone requires only one test, which makes it more cost-effective for patients who might not be able to afford two tests.
However, the recent FDA approval for HPV primary screening is limited to a single commercially available test and to one of two liquid-based Pap tests. The authors suggest that additional tests should be approved.
Dr. Thomas Wright, professor emeritus of Pathology and Cell Biology at Columbia University in New York, NY, says:
"Our results, from the first prospective US study to evaluate the performance of HPV primary screening, have shown clearly that this new screening approach should be considered as an option for women 25 years and older.
In order to facilitate the widespread adoption of this safe and effective method of screening, it would be advantageous to have additional HPV tests and the other liquid-based Pap tests approved. We hope that our research will help reduce morbidity and mortality from cervical cancer worldwide."