GAITHERSBURG, Maryland and HILDEN, Germany, October 18 /PRNewswire/ -- The first randomized, controlled study in North America of HPV testing as a stand-alone screen concluded that it is almost 40 percent more accurate than traditional cytology (the Pap "smear") in identifying women with advanced cervical disease, according to a report published today in The New England Journal of Medicine.
The study, which involved more than 10,000 Canadian women age 30-69, found that the HPV test's sensitivity - its ability to accurately identify women with pre-cancerous cervical cells or cancer - was 94.6 percent, compared to 55.4 percent for the Pap. HPV (humanpapilloma virus) is the primary cause of cervical cancer.
This seminal study used QAIGEN's Hybrid Capture(R) 2 High-Risk HPV DNA test -- the only such test that is both CE-marked in Europe and approved by the U.S. Food and Drug Administration(1). The molecular diagnostic test was developed by Digene Corp., now part of QIAGEN N.V. (NASDAQ: QGEN; Frankfurt, Prime Standard: QIA). The performance of QIAGEN's HPV test has been validated in studies that included more than 300,000 women.
"We already knew before conducting this study that the sensitivity of the Pap left a lot to be desired," stated one of the study's authors, Eduardo Franco, DrPH, of Montreal's McGill University, in a news announcement. "However, 55.4 percent accuracy is only slightly above chance. Flipping a coin gives you 50 percent."
Participants in the Canadian Cervical Cancer Screening Trial (CCCaST)
were randomly assigned to a "focus on Pap" or "focus on HPV" screening
group, although for ethical reasons, both groups received both tests. In
this study, conventional cytology was used. Recent analyses have found that
the newer "liquid-based" cytology does not significantly improve the
ability to detect disease. All CCCaST participants who tested positive on
either the Pap or HPV test were referred for a follow-up biopsy. In
|SOURCE QIAGEN N.V.|
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