Earlier today the FDA approved the first human papillomavirus (HPV) DNA test, cobas®, that can be used alone to screen for cervical cancer. FDA's approval clears the way for the cobas® HPV test (manufactured by Roche Molecular Systems) to challenge the Pap test as the first-line standard of care for cervical cancer screening.
HPV is among one of the most common sexually transmitted infections. Approximately 14 "high-risk" HPV types are associated with cervical cancer. Although most high-risk HPV infections go away on their own and do not cause any health problems, about 10% of high risk HPV infections persist and heighten a woman's risk of developing cervical cancer. Nearly all cervical cancers are caused by HPV infections, with two types -- HPV 16 and HPV 18 --responsible for 70% of cervical cancers.
Under FDA's guidelines, women who test positive under the cobas® HPV Test for HPV 16 or HPV 18 should then have a colposcopy. (A colposcopy uses a device that illuminates and magnifies the cervix so that a doctor can directly observe the cervical cells.) Women who test positive under the cobas® HPV test for one or more of the other 12 high-risk HPV types should then have a Pap Test to determine the need for a colposcopy.
During an earlier meeting in March, an FDA panel concluded that the cobas® HPV test was more effective in detecting women with disease and required fewer women without disease to go to colposcopy. The panel also recommended that the HPV test replace the Pap Test as the first-line standard of care for cervical cancer screening.
Related Alert: Roche's DNA Test May Replace Pap Smears (3/13/2014).
[1] FDA, "FDA approves first human papillomavirus test for primary cervical cancer screening," April 24, 2014.
HPV is among one of the most common sexually transmitted infections. Approximately 14 "high-risk" HPV types are associated with cervical cancer. Although most high-risk HPV infections go away on their own and do not cause any health problems, about 10% of high risk HPV infections persist and heighten a woman's risk of developing cervical cancer. Nearly all cervical cancers are caused by HPV infections, with two types -- HPV 16 and HPV 18 --responsible for 70% of cervical cancers.
Under FDA's guidelines, women who test positive under the cobas® HPV Test for HPV 16 or HPV 18 should then have a colposcopy. (A colposcopy uses a device that illuminates and magnifies the cervix so that a doctor can directly observe the cervical cells.) Women who test positive under the cobas® HPV test for one or more of the other 12 high-risk HPV types should then have a Pap Test to determine the need for a colposcopy.
During an earlier meeting in March, an FDA panel concluded that the cobas® HPV test was more effective in detecting women with disease and required fewer women without disease to go to colposcopy. The panel also recommended that the HPV test replace the Pap Test as the first-line standard of care for cervical cancer screening.
Related Alert: Roche's DNA Test May Replace Pap Smears (3/13/2014).
[1] FDA, "FDA approves first human papillomavirus test for primary cervical cancer screening," April 24, 2014.
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