FDA Review Panel Votes for HPV Test to Possibly Replace Pap Test

FDA Review Panel Votes For HPV Test to Possibly Replace Pap Test

A review panel from the U.S. Food and Drug Administration voted 100 percent in favor on Wednesday of a new HPV test that could be used either before or even possibly replace the Pap smear as the beginning step in detecting cervical cancer in women. There were three different voting procedures taken and in all they came back with the same results. The FDA’S microbiology board decided that the human papillomavirus (HPV) test, which is produced by the company Roche Molecular Systems, is effective and safe when used as a first line screen of defense for cervical cancer.

At the present time, females are tested for HPV when they have a Pap test or after a Pap smear alerts physicians to abnormal changes on the cervix. However this new test detects HPV DNA as a top source for finding any sort of abnormalities. HPV screening is very important due to HPV being the cause of around 70 percent of all cervical cancers. The FDA committee gave the new HPV test the green light to begin being used on women at age 25. It is believed that the added HPV testing will give a remarkable improvement in the warning of various types of cervical cancer.

HPV is a sexually transmitted virus and is believed to be behind the majority of cervical cancer cases as was mentioned above. Specific high risk versions such as HPV 16 and HPV 18 are the ones which are thought to be the most closely linked to cancer tumors. The HPV virus also produces genital warts in both women and also men and even is believed to cause certain neck and head cancers.

Roche is looking at the FDA to give approval toward the HPV test it makes very quickly. Females who end up testing positive for either of the high HPV risk strains would need to have a colposcopy. This would allow their doctor to use a device which would allow a clear observation of the cervix, vagina and vulva and the physician would be able to take other samples for even more advanced testing.

Yet, even with women who failed to have either HPV 16 or HPV 18 but did carry different high chance risk versions of the virus would then proceed to having a Pap test done in order to find out if they would need a colposcopy or not. The information the FDA group went over came from a clinical trial that included over 47,000 women.

Now it will be a wait and see process whether primary care physicians will start using an HPV test before a Pap test or not and the decision will be based on the clinical information backing it and how doctors and patients become more educated. The present guidelines still are in favor of using Pap tests first but those are always evolving.

It must also be remembered that even though screening for cervical cancer is very important, that is not the only reason women need to be having gynecological exams. They should be keeping an eye on the present guidelines and continue to have regular examinations but for more reasons than just HPV. Good gynecological health is more than just having screenings for cervical cancer. That good health can start early with two approved vaccines, Cervaris and Gardasil, that are both on the market. They each protect against HPV. The U.S. Centers for Disease Control and Prevention endorses all young girls and boys to start to be given the vaccination at around the age of nine.

The FDA review panel voted 100 percent in favor on Wednesday of a new HPV test that could be used either before or even as a possible replacement for the Pap smear as the beginning step in detecting cervical cancer in women.

By Kimberly Ruble

Sources:

FOX News

Philly News

Time News

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