Roche's Cobas HPV DNA test got a unanimous "yes" vote by and FDA committee to becoming the "test instead of the pap test," as the first screen for cervical cancer. Final FDA approval is waiting.Pap tests then would only be added on to women who have a positive HPV test. The reasons for this lies in the accuracy and ease of this test and in the data that shows that while we do a great job now, we can improve detection, and possibly even save health care dollars with a new strategy. Pap smears alone are only 50% accurate, but the HPV test, based on the Roche ATHENA trial are thought to be 90% accurate. But there is a lot for individual patients to consider. Do you understand the switch? What will your gyno recommend, and how would you as a woman handle getting told you just got tested for "an STD" instead of getting tested for "cancer." And since your HPV status can change with each partner, are you going to want more frequent HPV tests than you currently want pap smears? The American College of Obstetricians and Gynecologists (ACOG) has questions about the new pap smear and HPV test proposals and has raised the questions about testing and specifically how we will get recommendations for different age groups. Gynos will be watching this story carefully, and women should be too. Dr. Suzanne Trupin was a principal investigator in the ATHENA trial and has been a consultant to Roche.
Roche's Cobas HPV DNA test got a unanimous "yes" vote by and FDA committee to becoming the "test instead of the pap test," as the first screen for cervical cancer. Final FDA approval is waiting.Pap tests then would only be added on to women who have a positive HPV test. The reasons for this lies in the accuracy and ease of this test and in the data that shows that while we do a great job now, we can improve detection, and possibly even save health care dollars with a new strategy. Pap smears alone are only 50% accurate, but the HPV test, based on the Roche ATHENA trial are thought to be 90% accurate. But there is a lot for individual patients to consider. Do you understand the switch? What will your gyno recommend, and how would you as a woman handle getting told you just got tested for "an STD" instead of getting tested for "cancer." And since your HPV status can change with each partner, are you going to want more frequent HPV tests than you currently want pap smears? The American College of Obstetricians and Gynecologists (ACOG) has questions about the new pap smear and HPV test proposals and has raised the questions about testing and specifically how we will get recommendations for different age groups. Gynos will be watching this story carefully, and women should be too. Dr. Suzanne Trupin was a principal investigator in the ATHENA trial and has been a consultant to Roche.
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