New Guidelines for Pap Smears

Ok, I know that getting a pap smear is about as exciting as a root canal (personally I've never had either :), but when you go to your local gynecologist there is something new you should ask for if you are 30 or older. Ask for HPV genotyping with your pap.

HPV (human papilloma virus) made a big splash on the marketing venues with the release of the vaccine Gardasil (if you haven't been to the web site click on the link...very interactive and informative). Up until March 2009 when the FDA approve a new test the only thing that we as physicians were concerned about was the entire group of high risk strains of HPV. It is well established that the most virulent strains are 16 and 18.

The FDA approved Cervista:

Descriptions of New FDA-approved HPV DNA Tests

In March 2009 the FDA announced approval for clinical use in the U.S. of two new HPV DNA diagnostic
tests.

• One of these tests is designed to identify 14 high risk types of HPV. These include the 13 types detected by the Hybrid Capture® 2 HPV DNA Assay (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68) as well as HPV 66. This test will be marketed under the name Cervista™ HPV HR. The other test is designed to specifically detect HPV 16 and HPV 18 and will be marketed under the name Cervista™ HPV 16/18. Both tests utilize an isothermal enzymatic DNA amplification process with a fluorescent read out and both are approved for use with ThinPrep® samples. They were developed by Third Wave Technologies which was acquired in 2008 by Hologic Inc., the manufacturer of the ThinPrep® Pap test.
  

FDA Approved Indications

• The FDA-approved clinical indications for Cervista™ HPV HR are similar to those of the Hybrid Capture® 2HPV DNA Assay. These are:
  

1. To screen patients with ASC-US cervical cytology results to determine the need for referral to colposcopy.
2. Used adjunctively with cervical cytology to screen women 30 years and older to assess the presence or absence of high-risk HPV types.
   

The FDA-approved indications for the Cervista™ HPV 16/18 test are:

1. In women 30 years and older the test may be used adjunctively with the Cervista™ HPV HR test in combination with cervical cytology to assess the presence or absence of specific high-risk HPV types.
2. Used adjunctively with the Cervista™ HPV HR test in patients with ASC-US cervical cytology results, to assess the presence or absence of specific high-risk HPV types. The results of this test are not intended to prevent women from proceeding to colposcopy

Succintly put: In a low risk 30+ y/o female the new guidelines are to perform a thin prep pap accompanied by Cervista. If the patient has a negative pap and a +screening for cervista (i.e. the presence of 16 or 18) then she should have a colposcopy done to look for cervical dysplasia. Because of the genotyping we are able to pick out the women that will be at highest risk for cervical dysplasia and/or cancer.

So when you go back for your ANNUAL (put it big letters so you don't forget to call for an appointment) ask for HPV typing if you are 30 or over.