Part 13 of IVD Hall of Fame
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In 1976, Harald Zur Hausen published a hypothesis that the human papillomavirus (HPV) had an important role in the development of cervical cancer. Thus began a controversy with other scientists who believed herpes simplex virus to be the cause of cervical cancer. Seven years later in 1983, and again in 1984, Zur Hausen and his colleagues published papers detailing their discovery of HPV16 and HPV18 in cervical cancer tumors. In 2008, Zur Hausen won a Nobel Prize in Medicine for the discovery.
Today, it is estimated (CDC) that 12,000 women in the US get cervical cancer every year. HPV is the main cause of these cancers. However, given that at least 50% of all sexually active people will have HPV at some point in their lives, only a relatively small number of women develop cervical cancer. The reason is that not all HPV viruses can cause cervical cancer. And even if the riskier virus is present, it doesn’t mean that a woman will develop cervical cancer.
Roughly 5 years after Zur Hausen et al. published their findings linking HPV16 and 18 to cervical cancer, the FDA approved the first test for HPV DNA, manufactured by Diagene (now Qiagen). The test was to be used in only conjunction with Pap testing to assess the presence or absence of high-risk HPV types. An abnormal Pap test result, coupled with a positive HPV test result and other risk factors, would be used to guide patient management, including further testing. Today there are several approved tests on the market for HPV screening, the most recent being the Gen-Probe APTIMA HPV assay, which detects (but does not discriminate) the 14 high-risk HPV types.
CDC guidance on HPV testing recommends their use for either screening (along with Pap tests) in women over 30 years of age, or in the case of an abnormal Pap result in women over 21 years of age. Though many of these tests still have issues with specificity, they have a very good negative predictive value (>95%). Therefore a negative result from an approved HPV assay, coupled with a normal Pap result corresponds to a very low risk of disease. So while it's true that HPV assays can be useful in the diagnosis of cervical cancer, perhaps their greatest contribution to date is giving women the peace of mind that their risk of developing the disease is low.