Release date: 2014-06-13 Roche announced on June 10 that Health Canada has approved the human papillomavirus (HPV) test kit cobas 4800 HPV Test as a first-line, primary screening tool for primary women with cervical cancer aged 25 and over. Screening. At the same time, Roche has also introduced a fully automated CINtec PLUS cytology test kit to improve early detection and early intervention of cervical cancer. Health Canada has approved the CINtec PLUS Cytology Test Kit to help identify women with high-prevalence cervical lesions who need immediate colposcopy. Roche's cervical cancer screening portfolio provides the most comprehensive strategy for cervical cancer prevention and treatment. The cobas 4800 HPV Test assesses the risk of cervical cancer based on the presence of clinically relevant highest-risk HPV (type 16/18) DNA. The kit provides HPV 16/18 genotyping information as well as another 12 Genotyping information for high-risk HPV and giving a summary of the test results. The approval of the new indication for the cobas 4800 HPV Test is based on the landmark ATHENA study, which involved more than 47,000 women, and the data showed that the vast majority of women benefited from the cobas HPV Test primary screening. In addition, ATHENA studies have shown that nearly one-seventh of cervical cytology (Pap smear) results are normal but actually HPV 16-positive women with high cervical disease are missed in cytology . Cervical cancer is largely a preventable disease. It has now been recognized that HPV is a cause of almost all cervical cancers worldwide. Women need better screening tools, including HPV primary screening, to reduce the risk of cervical cancer. HPV causes 99% of cervical cancer, while the highest-risk HPV (16/18) accounts for 70%. For decades, women have relied on cervical cytology as a tool to detect the presence or absence of cervical cancer. Previously, the cobas 4800 HPV Test was also approved by the FDA as a first-line, primary screening tool for primary screening of cervical cancer in women 25 years of age and older. The approval made the cobas 4800 HPV Test the first and only HPV test kit in the United States for primary screening of cervical cancer in women. Source: Bio Valley
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