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Roche receives China Food and Drug Administration (CFDA) approval for the CINtec PLUS Cytology test to help prevent women from developing cervical cancer

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Additional Relevant Details China Food and Drug Administration (CFDA) approval of the CINtec PLUS Cytology test, designed to improve the detection and early intervention of pre-cancerous cervical disease.A multi-center study of five participating hospitals throughout China revealed greater overall performance of combined sensitivity and specificity of the CINtec PLUS Cytology test in determining which women are at higher risk of developing cervical cancer when compared to conventional screening methods like Pap cytology. This is consistent with previously published data and supported the approval of the test by the CFDA.Virtually all cervical cancer is caused by human papillomavirus (HPV) infections1, but only women with persistent HPV infections who have developed high-grade pre-cancerous cervical disease should be treated. The CINtec® PLUS Cytology test was developed to detect two biomarkers associated with persistent HPV infections that may lead to cancer, distinguishing them from those that are likely to resolve on their own.About 62,000 new cases of cervical cancer are reported annually in China, and about 30,000 women in China die from the disease every year2."With the launch of the fully automated CINtec PLUS Cytology test, we can offer women in China the most comprehensive cervical cancer screening portfolio in the industry, thus fulfilling our commitment of preventing these women from developing cervical cancer," said Wong Fatt Heng, General Manager, Roche Diagnostics China. "The CINtec PLUS Cytology test helps reduce over-diagnosis and improves the detection of pre-cancerous cervical disease, allowing early intervention."
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Occurred on:
Mar 08, 2016
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Related Keywords China Food And Drug Administration, Cfda, Cintec Plus Cytology, Cervical Cancer, Cervical Pre-cancer, Immunocytochemistry Assay, Cervical Disease, Hpv Infections, Cobas Hpv Test, Pap Cytology