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National Cervical Cancer Coalition


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PostPosted: Fri Mar 13, 2009 4:02 pm 
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Regulators Approve New HPV DNA Tests


Two new tests for the Human Papillomavirus (HPV) have been licensed by the Food and Drug Administration (FDA), arming 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, along with a Pap test, 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) might benefit from a quicker referral to other diagnostic procedures. The test is also indicated for use as part of routine cervical cancer screening, in combination with a Pap test, for women age 30 or over. Women in this age group with HPV are more likely to have persistent infections and elevated risk for cervical cancer. The indication for the Cervista HPV HR test is similar to that of Digene’s Hybrid Capture 2 HPV test, which was approved for clinical use in 2000.

The Cervista HPV 16/18 Genotyping test was also green-lighted by the FDA. This test checks directly for HPV types 16 and 18, which together are responsible for approximately 70% of cervical cancers. This test has promise in helping health care provides identify which women may be at greatest risk of developing the disease, and 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.

Copyright 2009 The American Social Health Association

Posted by Fredo

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