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Roche's CINtec PLUS Cytology Receives the US FDA's Approval as the First Biomarker-Based Triage Test to Improve the Prevention of Cervical Cancer

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Roche's CINtec PLUS Cytology Receives the US FDA's Approval as the First Biomarker-Based Triage Test to Improve the Prevention of Cervical Cancer

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  • The US FDA has approved Roche’s CINtec PLUS Cytology as the first biomarker-based triage test for women with HPV positive results- screened by using the Cobas 4800 HPV test. The approval is based on IMPACT study validating CINtec PLUS Cytology as a triage test in different screening scenarios in 35-000+ women in the US
  • Roche’s Cobas 4800 HPV test in combination with CINtec PLUS Cytology and CINtec Histology aids clinicians to improve the detection of cervical pre-cancer. The CINtec PLUS Cytology test is anticipated to be available in the US in H2’20
  • CINtec PLUS Cytology is the only test that utilizes dual-biomarker technology to detect p16 and Ki-67 simultaneously- thus providing an indication towards the presence of transforming HPV infections

Click here ­to­ read full press release/ article 

 Ref: GlobeNewswire | Image: Roche


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