Rethinking Cervical Cancer Screening

Sandra Adamson Fryhofer, MD


June 16, 2014

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Hello. I'm Dr. Sandra Fryhofer. Welcome to Medicine Matters. The topic: a new stand-alone cobas® HPV Test (Roche Molecular Systems, Inc.; Pleasanton, California) now approved by the US Food and Drug Administration (FDA) for primary cervical cancer screening. Here is why it matters.

We have come a long way since 1928, when Dr. Papanicolaou first proposed cancer cells on a vaginal smear as an early warning sign of cervical cancer. We now know that human papillomavirus (HPV) is the culprit and that persistent high-risk HPV infections lead to cervical cancers. The American College of Obstetricians and Gynecologists (ACOG) acknowledged this link when it updated its cervical cancer screening guidelines[1] to include co-testing every 5 years with both cervical cytology and HPV testing as a preferred screening option for women aged 30-65 years.

For younger women, those aged 21-29 years, ACOG recommended cytology screening only every 3 years but no HPV testing. But now there is another game change. The FDA has just expanded an approval of the cobas HPV test as a stand-alone test for primary cervical cancer screening for women aged 25 years and older.

The cobas HPV test is used to detect viral DNA in a cervical cell sample from 14 different high-risk HPV strains: types 16 and 18 along with 12 other HPV viruses. For women who test positive for types 16 and 18, the strains linked to over 70% of all cases of cervical cancer, the next step is colposcopy and cervical biopsy as indicated.

The FDA approves drugs and tests, but it can't change guidelines. So it will be interesting to see if organizations like ACOG will adjust their current cervical cancer screening recommendation guidelines with the advent of this new FDA approval ruling, especially in women aged 25-30 years.

For Medicine Matters, I'm Dr. Sandra Fryhofer.


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