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New HPV DNA Tests Approved

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First genotyping test licensed in the U.S. for clinical use

Two new tests for Human Papillomavirus (HPV) have been licensed by the Food and Drug Administration (FDA), providing health care professionals with additional tools to screen women for cervical cancer.

Hologic Corporation’s Cervista™ HPV High-Risk (HR) test was approved for use, in two ways.  Firstly as a follow-up test to determine which women with unclear Pap test results (known as Atypical Squamous Cells of Undetermined Significance, or ASC-US) have a high risk HPV and may benefit from a referral for additional diagnostic procedures, such as colposcopy and biopsy. Secondly, as a primary screening test in combination with a Pap test, for women age 30 or over as part of routine cervical cancer screening, Women in this age group with HPV are more likely to have persistent infections and an elevated risk for cervical cancer. The indication for the Cervista HPV HR test is similar to that of the Qiagen HPV Test Hybrid Capture 2, which was approved for clinical use in 2003.

The Cervista HPV 16/18 Genotyping test was also green-lighted by the FDA. This test checks for HPV types 16 and/or 18, which together are responsible for approximately 70% of cervical cancers. This test is approved for use (in combination with a Pap test and Cervista HR test) as primary cervical cancer screening with women age 30 and older) and to determine if HPV16/18 are present with ASC-US Pap results.

The ability to determine if a woman has HPV 16/18 specifically is a new wrinkle in cervical cancer screening; previously, such tests were confined to medical research studies. No clinical guidelines have incorporated the specific HPV 16/18 tests yet, but an algorithm issued by the American Society for Colposcopy and Cervical Pathology (ASCCP) suggests the potential advantage to genotyping may be in allowing women age 30 and older who are high-risk HPV positive – but negative for the more aggressive HPV 16/18 types – to avoid immediate referral to colposcopy in favor of repeating Pap and HPV tests in 12 months.

American Society for Colposcopy and Cervical Pathology. Clinical Update: HPV Genotyping. Retrieved online April 23, 2009