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Canada Clears Abbott HPV Molecular Diagnostic Test

NEW YORK (GenomeWeb News) – The Medical Device Bureau of Health Canada has granted a license to Abbott to market its RealTime High Risk HPV molecular diagnostic test for detecting human papillomavirus, Abbott announced today.

The test, which was CE marked in 2008, detects 14 high-risk HPV genotypes with simultaneous detection of HPV genotypes 16 and 18, which are known to pose the highest risk of progression to cervical cancer. About 70 percent of cervical cancer cases are found to have HPV 16 and/or 18, Abbott said.

The company's test is run on its m2000 RealTime molecular diagnostic system.

"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," Judy Yu, director of scientific affairs, Molecular Diagnostics, Abbott, said in a statement.

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