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
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
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.
Abbott's news releases and other information are available on the
company's web sites at www.abbott.ca and www.abbott.com .
Connect with us on Twitter at @AbbottNews.
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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