ABBOTT PARK, IL, May 29, 2013 /CNW Telbec/ - Abbott today 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.
The Abbott RealTime HPV assay has been CE Marked since 2008 and is available in Europe and some other areas outside the United States. The Abbott test demonstrates test performance characteristics which meet the standards set by the international consensus guidelines in multiple independent studies conducted in different European countries and demonstrates a high accuracy of sensitivity and specificity.
The test is performed on the Abbott m2000 RealTime molecular diagnostics system utilizing liquid-based cytology media.
About HPV and Cervical Cancer
HPV is one of the most common sexually transmitted infections in North America. Infected individuals are usually unaware they have HPV and are capable of infecting others. The virus is so common that experts estimate nearly all sexually active men and women contract HPV sometime in their lives. According to the U.S. Centers for Disease Control and Prevention, 90 percent of HPV infections are resolved without treatment as the body clears the infection within two years. Unresolved HPV infections, however, can cause genital warts and cervical cancer.
According to the Public Health Agency of Canada, cervical cancer is the second most prevalent malignancy in women worldwide. In fact, 1,450 Canadian women will receive a diagnosis this year of invasive cervical cancer, and approximately 420 women will die from this disease1.
Cervical cancer is typically found in women aged 30 to 59. Women at highest risk for HPV infection became sexually active at a young age and are non-monogamous. The average time from infection with HPV to onset of cervical cancer is 15 years, and the likelihood of developing cancer increases with age
About m2000 RealTime System
Abbott currently markets the m2000 RealTime System and a broad menu of assays globally. In addition to the RealTime High Risk HPV test, the company is the only molecular diagnostics supplier in Canada to offer viral load assays for HIV-1, hepatitis B, hepatitis C, cytomegalovirus, a hepatitis C genotype test, and a combination test for chlamydia and gonorrhea, on a single molecular platform. This enables laboratories to consolidate sexually transmitted and infectious disease testing on one platform to improve workflow and productivity.
About Abbott Molecular
Abbott Molecular is a leader in molecular diagnostics - the analysis of DNA and RNA at the molecular level. Abbott Molecular's tests can also detect subtle but key changes in patients' genes and chromosomes and have the potential to aid with early detection or diagnosis, can influence the selection of appropriate therapies, and may assist with monitoring of disease progression.
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000.
In Canada, Abbott has approximately 1,500 employees working in manufacturing, distribution and logistics, as well as sales and marketing. Primary locations in Canada are in Montreal, Markham, Mississauga, Brockville, Ottawa, Victoriaville and Edmonton.
1 Public Health Agency of Canada http://www.hc-sc.gc.ca/hl-vs/iyh-vsv/diseases-maladies/cervical-uterus-eng.php#ri , Accessed on May 14, 2013
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