New study confirms sensitivity of QIAGEN's digene HC2 HPV DNA Test

Oct. 1, 2014

A recently published study comparing three FDA-approved screening tests for human papillomavirus (HPV) provides the latest confirmation of 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 was published in the Journal of Clinical Microbiology.

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.

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 uses advanced Hybrid Capture 2 technology to directly detect the presence of 18 types of HPV and the assay 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. Learn more about HPV Testing with Hybrid Capture 2 (HC2) Technology.

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