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FDA Approves HPV Test as First Line Screening for Cervical Cancer

Article date: April 25, 2014

By Stacy Simon

The US Food and Drug Administration (FDA) has for the first time approved a human papilloma virus (HPV) test that can be used alone instead of the Pap test to screen for cervical cancer. Screening means having a test that looks for cancer or another disease in people who don’t have any symptoms. The test, called the cobas HPV test, examines a sample of cervical cells. It looks for 14 types of the virus, including types 16 and 18, which cause about 70% of all cervical cancers.

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The cobas HPV test was first approved by the FDA in 2011 for use with a Pap test or as a follow-up to a Pap test, which examines cervical cells for changes that might become cervical cancer. The new approval expands the use of the cobas HPV test, allowing it to be used either with the Pap test or all by itself for the early detection of cervical cancer in women 25 and older.

The FDA recommendation says if the cobas HPV test detects HPV types 16 or 18, women should have another test called a colposcopy, which uses a device to illuminate and magnify the cervix so a doctor can find abnormal areas that could be cancers or pre-cancers. If the cobas HPV test detects one of the other 12 HPV types, women should have a Pap test to determine the need for a colposcopy. Women who test negative for all 14 types should repeat the test in 3 years.

It is not yet clear how the new FDA approval will change the way most women are screened for cervical cancer in their doctors’ offices. The American Cancer Society is currently reviewing its guidelines for early detection of cervical cancer and considering the new information. The American Cancer Society currently recommends using either Pap and HPV tests together every 5 years, called co-testing, or a Pap test alone every 3 years for women 30-65. For women 21 through 29, the guidelines recommend a Pap test every 3 years, with an HPV test only if the Pap is abnormal. Screening is not recommended for women younger than 21.

About HPV

HPVs are actually a group of more than 150 related viruses. The 14 types detected by the cobas test are called high-risk because they can cause cancer. HPV that can cause cervical cancer is spread through sexual contact. It’s so common that almost all sexually active people get HPV at some point in their lives, even if they have sex with only 1 person in their lifetime.

Most people will never know they have HPV because they have no symptoms and their immune system gets rid of the virus. In most people, their immune system clears the HPV infection within 2 years. This is true of both high-risk and low-risk HPV types. But sometimes HPV infections are not cleared and over time, can lead to cell changes that over many years can turn into cancer.

Almost all cervical cancers are caused by HPV. Getting vaccinated can prevent infections with some types of HPV. The vaccines Gardasil and Cervarix prevent HPV types 16 and 18, which cause 70% of all cervical cancers. Gardasil also prevents the 2 types of HPV (6 and 11) that cause 90% of all genital warts. Cervarix may also provide some protection against some high-risk types of HPV in addition to 16 and 18. The vaccines work best to prevent cervical cancer and HPV infection when they are given to girls and women who are young and haven’t started having sex or have not yet been infected with HPV.

The American Cancer Society recommends the vaccination for girls ages 11 to 12. Vaccination can be given as young as age 9, and for girls who miss vaccination, through age 18. Women ages 19-26 who missed vaccination at a younger age may also be vaccinated but are less likely to receive full benefit.  According to Debbie Saslow, PhD, American Cancer Society director of breast and gynecologic cancer, many parents delay vaccination because they think their daughters are not sexually active or will not be for some time. But there are other reasons to vaccinate at age 11-12.  According to Dr. Saslow, studies have shown that younger adolescents have a better immune response to HPV vaccination than older adolescents. In addition, there are other vaccinations given at age 11-12, making it more convenient for parents, and younger adolescents are more likely to see a doctor than older ones.

Reviewed by: Members of the ACS Medical Content Staff


ACS News Center stories are provided as a source of cancer-related news and are not intended to be used as press releases. For reprint requests, please contact permissionrequest@cancer.org.

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