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HPV detection and prevention

A look at new tools and recent data

April 2009 · Vol. 21, No. 04

Two tests join the battle to prevent cervical cancer

The US Food and Drug Administration (FDA) approved two new human papillomavirus (HPV) tests in late March. Both are manufactured by Hologic, Inc.:

Cervista HPV HR–designed to detect the 14 high-risk types of HPV known to cause cervical cancer. It is the first HPV DNA test approved by the FDA in more than 10 years. It was approved for:

  • screening patients who have atypical squamous cells of undetermined significance (ASC-US) at the time of Pap testing, to determine the need for referral to colposcopy
  • adjunctive use with cervical cytology to screen women 30 years and older for high-risk HPV types.

Cervista HPV 16/18–the first HPV test approved for genotyping HPV types 16 and 18, which are associated with approximately 70% of all cervical cancers in the United States. The HPV strains identified by the Cervista HPV 16/18 test are the two most oncogenic and persistent types of HPV. Previous studies have shown HPV 16 and 18 to be 5.5 times and 4.5 times, respectively, more likely to cause cancer than all other high-risk HPV types combined.

The HPV 16/18 test was approved for:

  • adjunctive use with the Cervista HPV HR test and cervical cytology to screen women 30 years and older for high-risk HPV types
  • adjunctive use with the Cervista HR test in women who have ASC-US at the time of Pap testing, to screen for specific high-risk HPV types.

Results of the HPV 16/18 test are not intended to prevent women from proceeding to colposcopy.

Both tests are meant to be evaluated in light of the patient’s cytologic history, risk factors for cervical cancer, and professional guidelines.

HPV HR test was 100% sensitive for CIN 3

The Cervista HPV HR clinical trial was one of the largest and most demographically diverse conducted in the United States to date. It was held at 89 sites and enrolled approximately 4,000 women nationwide.

The trial met or exceeded all target endpoints. Most importantly, the Cervista HPV HR test achieved 100% sensitivity for detection of cervical intraepithelial neoplasia (CIN) 3, an immediate precursor to cervical cancer.

In comments to the press, officials from Hologic, Inc., said that they believe Cervista HPV HR provides more benefits than tests already on the market:

  • Cervista HPV HR includes an internal control intended to verify adequate cellularity for testing, thus reducing the potential for false-negative results.
  • Because Cervista HPV HR requires a smaller specimen volume, this technology may minimize inconclusive, or indeterminate results, which may lead to fewer patients being called back for repeat testing.
  • Cervista HPV HR is designed to minimize false-positive results that arise when a low-risk HPV strain is mistakenly recognized as a high-risk HPV strain.

For more information about these approvals, visit www.fda.gov/bbs/topics/NEWS/2009/NEW01974.html.

Related article:Update on cervical disease,” by J. Thomas Cox, MD, OBG Management (March 2009) www.obgmanagement.com/article_pages.asp=

How do parents learn about the HPV vaccine? For most, not from you, Doctor.

A new study of HPV vaccine awareness among caregivers of adolescent girls 10 to 18 years old shows that the great majority of them learn about the virus and the vaccine from drug company advertisements (83%) and broadcast media coverage (69%).

But when asked where they planned to obtain future information about the virus and vaccine, 88% of respondents said they would ask a health-care provider and 65% said they would consult the Internet.

Details of the study

In the study, 889 caregivers in southeastern North Carolina were asked about their knowledge of HPV. They correctly answered an average of 69% of questions about the virus, though correct responses differed by race and education. Overall, 87% of whites and 68% of African Americans had heard of the vaccine.

African Americans were less likely than Caucasians to have heard about the vaccine from advertisements but more likely to have heard about it from a broadcast source.

The study was conducted by the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill and by the Centers for Disease Control and Prevention (CDC). It was published in the February 1 issue of Cancer Epidemiology, Biomarkers & Prevention.

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