First HPV test for primary cervical cancer screening approved by FDA

April 28, 2014

FDA approved the first HPV DNA test for women aged 25 years and older that can be used alone to help a healthcare professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can offer information about the patient’s risk for developing cervical cancer in the future.

FDA approved the first HPV DNA test for women aged 25 years and older that can be used alone to help a healthcare professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can offer information about the patient’s risk for developing cervical cancer in the future.

The decision follows the unanimous (13 to 0) recommendation from an FDA Advisory Committee on March 12, which determined that the test was safe, effective and that its benefits outweighed its risks. The cervical cytology (Pap test) has been the traditional primary screening method for cervical cancer, but because HPV causes most cervical cancers, cytology testing is now done on all women, and HPV testing is done on some of those women according to their age and cytology results.

Using a sample of cervical cells, the cobas HPV Test (Roche) detects DNA from 14 high-risk HPV types. The test specifically identifies HPV 16 and HPV 18, while concurrently detecting 12 other types of high-risk HPVs.

Based on results of the cobas HPV Test, women who test positive for HPV 16 or HPV 18 should have a colposcopy, an exam using a device that illuminates and magnifies the cervix so a physician can directly observe the cervical cells. Women testing positive for 1 or more of the 12 other high-risk HPV types should have a Pap test to determine the need for a colposcopy. The cobas HPV Test results should be used together with other information, such as the patient screening history and risk factors, and current professional guidelines.   The approval does not change current medical practice guidelines for cervical cancer screening.

FDA first approved the test in 2011 for use in conjunction with or as a follow-up to a Pap test, which examines cervical cells for changes that might become cervical cancer.

One basis for FDA approval was the clinical data from the landmark ATHENA study, the largest United States-based registration study for cervical cancer screening which included more than 47,000 women. Data from that study showed that when the cobas HPV Test was compared to cytology-based screening, significantly more cervical disease was identified at baseline. FDA also considered HPV DNA screening algorithms, and 3-year data from the ATHENA study showing how the cobas HPV Test performed.

In the ATHENA trial, nearly one-third of cervical disease was found in study participants aged 25 to 29 years old, of which the majority had had normal cervical cytology results. Screening for high-risk HPV at this earlier age provides an opportunity to detect disease prior to progression.

Approximately 14 “high-risk” HPV types are associated with cervical cancer including genital HPVs, a group of more than 40 related viruses which, according to the Centers for Disease Control and Prevention (CDC), are the most common sexually transmitted infections.

In most cases, a high-risk HPV infection resolves on its own and does not cause any health problems. However, about 10% of women infected with high-risk HPV develop a persistent infection that may put them at risk of cancer. Virtually all cervical cancers are caused by HPV infections, with just 2 types, HPV 16 and HPV 18, responsible for approximately 70% of cervical cancers.