Abbott Introduces its RealTime Molecular Test for Human Papillomavirus (HPV) in Canada

Abbott announced it has been granted license by the Medical Device Bureau of Health Canada, for its RealTime High Risk HPV molecular diagnostic test for the detection of human papillomavirus (HPV), the leading cause of cervical cancer. Abbott’s 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. HPV genotypes 16 and 18 are known to pose the highest risk to progress to cervical cancer. “Molecular detection of high-risk HPV infections, in women over the age of 30, is an important adjunct to cervical cancer screening in Canada,” said Barbara Romanowski, MD, FRCPC, Clinical Professor, University of Alberta, Edmonton, Canada. “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,” said Judy Yu, Ph.D., director, scientific affairs, Molecular Diagnostics, Abbott. “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.” HPV is a group of viruses with more than 150 different genotypes. Fourteen genotypes are classified as high-risk HPV because of their association with cervical cancer. HPV genotypes 16 and 18 are known to pose the highest risk to progress to cervical cancer and are found in approximately 70 percent of cervical cancer cases.