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Thursday, April 24, 2014

HPV Testing Approved By FDA For First Line Cancer Detection!

Close to the May 13th birthday of Dr. George Papanicolaou's the FDA approves HPV test as the first line test for cervical cancer instead of getting a pap smear

 At Women's Health Practice we are excited to thank our ATHENA study participants for leading the way to one of the momentous FDA decisions of the decade. US Food and Drug Administration (FDA) today approved the cobas HPV Test (Roche Molecular Systems, Inc) for primary cervical cancer screening in women aged 25 years or older. This decision heavily relied on this test for their ruling. We have been following the FDA's position on this test. It was the first human papilloma virus (HPV) DNA test approved alone to detect high-risk HPV. The test is recommended for first-line screening, and can specifically identify HPV genotypes 16 and 18, which are responsible for about 70% of all cervical cancers. It also concurrently detects 12 other high-risk genotypes (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). If you go to your gyno for a pap she may in fact order an HPV test first. If that test shows you have a high risk HPV type, the 16 or the 18, you will likely be offered further testing, such as the colposcopy, to determine if you have precancer or cancerous changes of your cervix. If you do not have the high risk HPV,but test positive for other HPV types, the pap test will be done to help determine what additional screening you need. Based on the ATHENA study the  cobas HPV Test received FDA approval in 2011, to be used in conjunction with or as a follow-up to cell cytology, for women aged 30 years and older. Meaning, essentially,  if you have an abnormal pap you then would receive an HPV test to determine the need for further evaluation. Although this is the FDA rule, and your gyno may want to embark on this right away, the organizations which rule on protocols, such as ACOG, have not yet issued statements to their physicians on how they would like them to incorporate this into their recommendations on cervical cancer screening. Other organizations are now going farther and stating that HPV test may be better than pap tests. "Primary HPV screening might be a viable alternative to Pap screening alone," said Julia Gage, a new study's lead author from the National Institutes of Health's National Cancer Institute in Bethesda, Maryland. They found that doing the HPV test only is very accurate, but about 20 women out of 100,000 developed cervical cancer in the three years following a negative Pap test, compared to 11 of 100,000 who developed the cancer during the three years after receiving a negative HPV test. that means 10 women were missed. Would you want to be one of those ten who missed their chance for very early detection. For women interested in finding out more about HPV testing, or participating in future Women's Health Practice clinical research trials go to our website at www.womenshealthpractice.com

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