In 2014, the U.S. FDA approved the cobas® HPV Test as a first-line primary screening test for cervical cancer. This means that the cobas® HPV Test can now be used to replace the Pap test, if the doctor chooses to do so for primary screening.
In March 2014, a panel of experts advised the FDA that it was as safe and effective using the cobas® HPV Test in place of the Pap test as a first line test to screen for cervical cancer. In April 2014, the FDA made a decision to approve the cobas® HPV Test as a first-line, primary screen in women ages 25-65 years of age. It is the first and only FDA-approved test for first-line primary screening for cervical cancer.
The cobas® HPV Test is a more sensitive than the Pap test to identify women at risk of developing cervical cancer. The cobas® HPV Test was proven safe and effective for cervical cancer screening in a scientific study named ATHENA. This was the largest US study of its kind which included over 47,000 women.
The cobas® HPV Test is the only test approved by the FDA to be used as a first-line primary screening test for cervical cancer in women ages 25-65. This test individually identifies HPV 16 and HPV 18 along with a pooled result for 12 other high-risk HPV types. HPV 16 and HPV 18 are the highest risk types and known to cause about 70% of all cervical cancers.
The sample is collected in exactly the same way as it is for the Pap test. Your healthcare provider will use an instrument, called a speculum, to look into your vagina. Another device is then inserted to collect cell samples from the cervix. The samples are placed in a liquid bottle and sent to a laboratory for the HPV test.
The test is available today in many laboratories. Your doctor can determine if the cobas® HPV Test is right for you.
Tell your friends and loved ones about HPV cervical screening
WHAT EVIDENCE SUPPORTS
THE RECENT FDA APPROVAL?
THE FDA REVIEWED THE CLINICAL DATA FROM ROCHE’S LANDMARK ATHENA STUDY OF OVER 47,000 WOMEN IN THE US. THE DATA SHOWED:
Women who tested negative with the cobas® HPV Test were more than 2 times less likely to develop pre-cancer vs women who tested normal Pap.1
1 in 4 women who tested positive for HPV 16 developed pre-cancer or cancer.1
1 in 9 women who tested positive for HPV 18 developed pre-cancer or cancer.1