FDA approval of stand-alone HPV testing

The FDA approved an HPV DNA test for women >25 yo today  (see http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394773.htm ). the approved test (cobas test, by Roche) tests for 14 high-risk HPV types, including HPV 16 & 18. the FDA, citing a study by Roche, notes:

    --women positive for HPV 16 or 18 should go directly to culposcopy (HPV 16 or 18 are responsible for 70% of cervical cancer)

    --women positive for the other 12 types should get a regular Pap test to see if need culposcopy

    --although initially approved by the FDA in 2011 as a co-test with Pap, this approval now allows HPV testing to be either part of a co-test with Pap, or a primary screening test.

    --the Roche study involved 40K women > 25yo, doing culposcopy/cervical biopsy on those with positive Pap or HPV as well as some women negative for both, with 3 year follow-up, leading to the FDA approval

so, raises several questions (i have not seen the Roche study, so cannot comment further on that). given that 90% of HPV infections are transient and given the high frequency in women <30yo (as well as the increased likelihood that the infection would be transient), the previous guidelines were to avoid HPV testing til age 30. will lowering it to 25, as per the FDA, lead to more unnecessary invasive procedures in those 25-30 years old? it certainly will help Roche's bottom line...

here is blog from 3/15/14:

NY times reports unanimous vote by FDA subcommittee to replace pap smears with HPV testing alone. prior to this being a new policy, has to be approved by FDA (which almost always happens), though many providers may not use this test alone unless approved by professional societies. the initial test would be done at age 25. for full article: http://www.nytimes.com/2014/03/13/health/an-fda-panel-recommends-a-possible-replacement-for-the-pap-test.html?_r=0 

of note, 

    --approx cost (in houstin texas): $50 for pap, $150 for HPV

    --only one of the hpv tests, the one by roche (not the most common one done), is approved

    --the current guidelines (pap age 21-30 q3yrs, then combo pap/HPV after age 30 q5yrs), have consciously postponed hpv screening til age 30 because in younger sexually active women, these infections most often regress spontaneously and, if picked up by screening, could lead unnecessarily to more invasive followup procedures (eg culposcopy and maybe more).

will also append a prior blog below, sent out last year.

An article this week in the lancet found at that HPV-based cervical cancer screening was better than cytology-based methods (see hpv based screening for cervical cancer lancet 2013 in dropbox, or http://dx.doi.org/10.1016/S0140-6736(13)62028-0).  They looked at four randomized trials in Europe, with 176,000 women aged 20-64 assigned to HPV-based screening (in 3 of these studies it was combination cytology plus HPV) versus cytology screening alone.  Women were followed on average of 6.5 years to assess the development of invasive cervical carcinoma, with a screening interval of 3 years for those with a negative result.  107 invasive cervical cancers were found.  Although there was not any difference in the first 2-1/2 years of followup, thereafter it was found that HPV-based screening provided 60-70% greater protection against invasive cervical carcinoma as compared with cytology. their finding was even more significant in women in the 30-34 age range, an unanticipated result. They felt their data supported HPV screening from age 30 with screening intervals of at least every 5 years. 

 

Results from this study reinforce the decision at our Health Center (as per ACOG and USPSTF) to screen every 5 years for women aged 30 or older with HPV-based screening.  However, as recommended, we do the combination of cytology with HPV screening.  the study authors do raise the issue "because cotesting leads to many unnecessary colposcopy procedures, stand-alone HPV testing also seems recommendable". so, maybe we should be doing only HPV testing in women over the age of 30??

 

this article also raises peripherally the issue of cervical cancer screening in a woman who has never been sexually active, or continued cervical screening on patients who have had negative prior HPV screening and are no longer sexually active (the subtext here is: cervical cancer is basically a sexually transmitted disease caused by certain specific strains of HPV).  i personally do not perform cervical cancer screening in women who have never been sexually active (the issue here, though, is to be certain that the woman really has not been sexually active). for women who have had adequate negative screens (eg, normal HPV screens twice in the preceding 10 years), and have not been in a sexual relationship for several years and with a very high probability of not getting into one (as with many of our patients from some different cultural backgrounds), it seems reasonable to me to stop screening. (and, not so surprisingly, when i ask if they would like a vaginal exam, the answer is almost always a resounding “no”). this is not the recommendation of ACOG or USPSTF, but seems to make sense based on the information at hand.