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Abbott Releases RealTime Molecular Assay For Detection Of HPV Infection In Europe

Abbott Molecular introduced the real-time polymerase chain reaction (PCR) based diagnostic test for human papillomavirus (HPV). The CE-marked assay can identify patients infected with specific viral genotypes known to pose the highest risk for progression to cervical cancer. Abbott RealTime High Risk HPV assay detects the 14 highest risk HPV genotypes and, in the same procedure, can identify women infected with the HPV 16 and HPV 18 genotypes, which account for more than 70 percent of cervical cancer cases. The assay can rapidly identify HPV-infected patients at risk for cervical cancer by combining two diagnostic tools in one test - HPV high-risk screening and viral genotyping. "The Abbott RealTime HPV assay is a major advance that provides clinicians with three results in one assay: detection of the 14 HPV high risk types as well as genotyping to determine if the highest risk HPV 16 and 18 genotypes are present in the sample," said Jack Cuzick, Ph.D., professor of epidemiology, Barts and the London, Queen Mary's School of Medicine and Dentistry. "Women with abnormal PAP smear test results will know right away if they are at risk for developing cervical cancer. A negative result from this test will assure them with almost 100 percent certainty that cervical cancer will not occur in the next few years. " In scientific evaluations at clinical sites across Europe, the Abbott RealTime High Risk HPV assay demonstrated high accuracy, with specificity of 99.4 percent and sensitivity of 97.5 percent for qualitative detection of the 14 high-risk HPV genotypes. The new assay uses liquid-based cytology specimens and runs on the Abbott m-Systems - m2000 for large-volume testing laboratories and m24sp or manual for labs performing small- to mid-sized volumes.