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Abbott receives license in Canada for RealTime High Risk HPV molecular diagnostic test

Global health care company Abbott has received license from the Medical Device Bureau of Health Canada for its RealTime High Risk HPV molecular diagnostic test to detect human papillomavirus (HPV), a primary cause of cervical cancer.

The RealTime High Risk HPV test is designed to detect 14 high-risk HPV genotypes with simultaneous detection of HPV genotypes 16 and 18 in one assay. These genotypes pose the highest risk to progress to cervical cancer.

University of Alberta Canada clinical professor Barbara Romanowski said, "Molecular detection of high-risk HPV infections, in women over the age of 30, is an important adjunct to cervical cancer screening in Canada."

Abbott Molecular Diagnostics scientific affairs director Judy Yu said that women with abnormal pap tests, especially those at borderline, can be tested with a rapid HPV DNA test to detect the presence of high-risk HPV.

"HPV DNA tests, like the Abbott RealTime High Risk HPV test, combined with high specificity of cytology, can direct the appropriate management strategies for women with abnormal pap results," Yu added.

HPV is a group of viruses with more than 150 different genotypes in which 14 genotypes are classified as high-risk HPV because of their association with cervical cancer.

The Abbott RealTime HPV assay is available in Europe and some other areas outside the US. The test is performed on the Abbott m2000 RealTime molecular diagnostics system utilizing liquid-based cytology media.