What is the HPV test?
QIAGEN developed the first FDA-approved test to detect the presence of high-risk (cancer-causing) types of HPV. The digene HPV Test, which uses the company’s proprietary Hybrid Capture® 2 (hc2) technology, was approved by the U.S. Food and Drug Administration (FDA) in 1999 for follow-up evaluation of women whose Pap results are inconclusive (“ASC-US”), allowing healthcare providers to determine whether they need further examination. In 2003, the digene HPV Test was approved for routine use along with a Pap for all women 30 years of age and older, the group considered most at risk of cervical cancer. Click here (PDF) for full medical and technical information on the digene HPV Test. The ability to identify women at risk has repeatedly been shown to be greater when the HPV test is done along with the Pap than when the Pap smear is used alone. On average, studies show that the combination of the digene HPV Test and the Pap identifies 95-100 percent of advanced cervical disease (CIN 2, CIN
