Get ready for changes in HPV DNA testing
Get ready for changes in HPV DNA testing
The Food and Drug Administration (FDA) has approved two new tests for human papillomavirus (HPV). How does the addition of these tests affect current practice?
The Cervista HPV 16/18 test detects the DNA sequences for HPV types 16 and 18 in cervical cells, while the Cervista HPV HR test detects essentially all of the high-risk HPV types in cervical cell samples. The two tests, both developed by Hologic, are designed to use the same cervical sample collected with its ThinPrep Pap Test. Rollout of the tests is not immediate, says Jeff Keene, company spokesman. Sales force training and laboratory validation are under way. The tests are designed to be run in any Clinical Laboratory Improvement Amendments (CLIA) high-complexity lab.
Providers are familiar with HPV testing, with the Hybrid Capture HPV molecular diagnostic assay from Qiagen as the first FDA-approved assay. Qiagen merged with Digene Corp. in 2007.
HPV is the most common sexually transmitted disease (STD) in the United States. The Centers for Disease Control and Prevention estimates that more than 6 million Americans become infected with genital HPV each year and that more than half of all sexually active women and men become infected at some time.1
For many women, HPV usually goes away on its own without causing health problems. However, some HPV types can cause cell abnormalities on the lining of the cervix that later might become malignant. While there are more than 50 types of HPV that can infect the genital area, types 16 and 18 cause about 70% of all cervical cancers.
It is important to understand the appropriate use of this new technology, says Susan Wysocki, RNC, NP, president and CEO of the Washington, DC-based National Association of Nurse Practitioners in Women's Health. "In anticipation that HPV typing would be approved, the American Society for Colposcopy and Cervical Pathology [ASCCP] prepared guidelines for the use of these tests," explains Wysocki. The guidelines were released following announcement of the approval and can be found at www.ASCCP.org, she says. (Editor's note: To access the guidelines, go to the ASCCP web site and select "Consensus Guidelines," then "Clinical Update: HPV Genotyping." Providers also can access an algorithm highlighting use of HPV genotyping to managing HPV HR-positive/cytology negative women ages 30 and older. It also is available under "Consensus Guidelines" click on "2009 Algorithm: Use of HPV Genotyping to Manage HPV HR * Positive/Cytology Negative Women 30 Years and Older.)
According to Hologic, the Cervista HPV HR test has been approved for two uses:
- To screen patients with atypical squamous cells of undetermined significance (ASC-US) cervical cytology results to determine the need for referral to colposcopy.
- For adjunctive use with cervical cytology to screen women ages 30 and older to assess the presence or absence of high-risk HPV types.
The Cervista HPV 16/18 test also has been approved for two uses:
- For women 30 years and older, the test may be used adjunctively with the Cervista HPV HR test with cervical cytology to assess the presence or absence of specific high-risk HPV types.
- For adjunctive use with the Cervista HPV HR test in patients with ASC-US cervical cytology results to assess the presence or absence of specific high-risk HPV types. The results of this test are not intended to prevent women from proceeding to colposcopy, the company notes.
As HPV DNA testing becomes more widespread, there are situations in which high-risk HPV DNA testing and genotyping are NOT recommended, according to the ASCCP guidance. These situations include:
- adolescents (defined as women ages 20 years and below), regardless of their cytology results;
- routine screening in women before age 30;
- women considering vaccination against HPV;
- routine STD screening;
- as part of a sexual assault work-up;
- women with atypical squamous cells of undetermined significance (ASC-US);
- as the initial screening test for women ages 30 and older.
- women 21 years and older with ASC-H [atypical squamous cells — cannot exclude high-grade squamous intraepithelial lesion (HSIL)], low-grade squamous intraepithelial lesion (LSIL), or HSIL cytology]. The ASCCP notes that "reflex" HPV testing is acceptable in postmenopausal women with LSIL.2
The ASCCP notes situations exist in which its 2006 consensus guidelines recommend limits on the frequency of HPV DNA testing to avoid overtesting and unnecessary treatment. When clinicians are managing women with ASC-US, the ASCCP recommends that HPV DNA testing not be performed at intervals of less than 12 months. In addition, women ages 30 and older who are negative by cytology and high-risk HPV DNA testing should not be rescreened — using cervical cytology or HPV DNA testing — before three years.
Providers may see more HPV tests: Roche Diagnostics also has a molecular HPV test under review at the FDA. Other companies evaluating HPV molecular diagnostics include Abbott Diagnostics, Gen-Probe, Arbor Vita Corp., and Sensigen.
References
- Centers for Disease Control and Prevention. Genital HPV Infection. CDC Fact Sheet. Accessed at www.cdc.gov/std/HPV/STDFact-HPV.htm.
- American Society for Colposcopy and Cervical Pathology. Clinical Update: HPV Genotyping. Accessed at www.asccp.org/pdfs/consensus/clinical_update_20090408.pdf.
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