The FDA approved an HPV DNA test for women >25 yo (see here). 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… review the blog from 3/18/14 (see here) 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).
this will also append a prior blog from last year (see here) geoff