Abbott receives Health Canada licence for RealTime High Risk HPV test

29 May 2013 (Last Updated May 29th, 2013 18:30)

Global healthcare company Abbott has received a licence from the Medical Device Bureau of Health Canada for its RealTime High Risk HPV molecular diagnostic test, which is designed to detect human papillomavirus (HPV), the leading cause of cervical cancer.

Global headquarters in Abbott Park, Illinois

Global healthcare company Abbott has received a licence from the Medical Device Bureau of Health Canada for its RealTime High Risk HPV molecular diagnostic test, which is designed to detect human papillomavirus (HPV), the leading cause of cervical cancer.

The HPV test is an in-vitro polymerase chain reaction (PCR) assay that utilises homogeneous target amplification and detection technology for the detection of high-risk HPV DNA in cervical cells collected in liquid cytology media.

It is designed to detect 14 high-risk HPV genotypes with simultaneous detection of HPV genotypes 16 and 18 in one assay.

Women infected with HPV 16 and / or HPV 18 have an increased risk of progression to dysplasia and cervical cancer compared to women infected with other high-risk HPV genotypes.

Abbott Molecular Diagnostics scientific affairs director Dr 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 said.

The Abbott RealTime HPV assay, which has been CE Marked since 2008, is available in Europe and some other areas outside the US.

The test is performed on the Abbott m2000 RealTime molecular diagnostics system, which utilises liquid-based cytology media.

HPV is a group of viruses with more than 150 different genotypes, and is one of the most common sexually transmitted infections in North America.

While 90% of HPV infections are cleared by the body without treatment within two years, unresolved HPV infections can cause genital warts and cervical cancer.


Image: Global headquarters in Abbott Park, Illinois. Photo: Courtesy of Abbott.