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Roche Reports FDA Approval Of CINtec PLUS Cytology - Quick Facts

Roche (RHHBY) said US FDA has approved CINtec PLUS Cytology as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus. The test identifies those women whose HPV infections are most likely to be associated with cervical pre-cancers. The new test can be performed using the same liquid sample that is used for HPV or Pap cytology testing.

The company anticipates CINtec PLUS Cytology to be widely commercially available in the US later in 2020.

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