A recently published study comparing three FDA-approved screening tests for human papillomavirus (HPV) provides the latest confirmation of superior sensitivity for QIAGEN's digene HC2 HPV DNA Test. HPV is the primary cause of cervical cancer, a cancer that can be deadly when the disease goes undetected and untreated.
The study at Mayo Clinic compared the performance of FDA-approved HPV tests on 350 women with inconclusive or abnormal PAP (≥ ASC-US) using biopsy results as the reference standard. Biopsy results of the 350 patients found 81 cases to have moderate to severe HPV related disease (CIN2+). Of these cases the digene HPV Test correctly identified 97.5% of the CIN 2+ patients, while the other FDA-approved tests each only correctly identified 91.4% of the CIN 2+ infections.
"The digene HPV Test is the world's most proven tool for sensitive, early detection of high-risk HPV, and the latest study confirms the benefits which are demonstrated in more than 300 previous peer-reviewed articles," said Dr. Tadd Lazarus, Chief Medical Officer of QIAGEN. "QIAGEN's HC2 technology has been evaluated in clinical trials involving more than 1 million women - and proven through 15 years of clinical practice and more than 90 million tests worldwide using the digene HPV Test. Co-testing with Pap smears and our HC2 technology has proven to be up to 100% sensitive for detection of CIN 2+ HPV."
Dr. Patricia Braly, a nationally recognized gynecologic oncologist at Women's Cancer Care in Covington, Louisiana, commented: "Sensitivity is the key in selecting an HPV test, because the goal of screening is to rule out HPV disease with a high level of confidence - and to identify patients in need of more evaluation and treatment. With the time between screenings now extending to five years for many women, we cannot afford the risk of 'false negatives' that miss patients who may have CIN 2+ disease - or even cervical cancer. This is why my clinic relies on examination and co-testing with the Pap smear and digene HPV Test to protect our patients."
Cervical cancer affects worldwide approximately 500,000 women annually and is the second-most-common malignancy in women after breast cancer. The cause of cervical cancer is the human papilloma virus (HPV), and women who have HPV infections can be identified. Cervical cancer is highly preventable and treatable.
The digene HPV Test, is the unrivalled "gold standard" in testing for high-risk types of HPV The digene test uses advanced Hybrid Capture 2 technology to directly detect the presence of 18 types of HPV and is the only HPV assay that examines the entire length of the genome, which helps prevent false negatives caused by gene deletions that occur naturally during a woman's biological integration of the HPV virus. When the digene HPV Test rules out high-risk HPV, the result is highly reliable, based on the higher sensitivity of the HC2 technology. This benefit is seen to be of critical value in screening settings, in particular as intervals between screenings are extended.