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Home Screening and Treatment Testing and Treatment FDA Approves Roche HPV Test

FDA Approves Roche HPV Test

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The Food and Drug Administration has approved Roche’s cobas® HPV test for use in the U.S. Lady in PinkIn a press release the company said the new HPV test detects 14 “high risk” types of HPV while also allowing concurrent detection of HPV 16 and 18, respectively, the two types of HPV found with about 70% of cervical cancers worldwide.

Other HPV tests on the market in the U.S. include the digene Hybrid Capture II ™ HPV test ™ and the Hologic, Inc. Cervista™ HPV High-Risk (HR) test. Additionally, Hologic also makes the Cervista HPV 16/18 Genotyping test which also checks directly for HPV types 16 and 18.

HPV tests are approved for use in two different cervical cancer screening situations:

  1. As a follow-up test if the Pap result is borderline between "normal" and "abnormal." This is usually called "atypical squamous cells" or "ASC-US." The HPV test is then used in the lab to determine if women with the borderline result are more likely to have precancerous changes on their cervix, (HPV positive), and which are more likely to just have normal cells (HPV negative). The HPV test helps to rule out whether HPV is causing the borderline abnormal cells.
  2. As a cervical cancer screening test in combination with a Pap test in women at or over age 30 (rather than just having the Pap test alone). Research shows that the combination test can increase the effectiveness of detecting any problems early on.

The ability to determine if a woman has HPV 16/18 specifically is a fairly new wrinkle in cervical cancer screening. The potential advantage of this “genotyping” may be to allow women 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.