Roche’s CINtec PLUS Cytology Test Receives the US FDA’s Approval to Aid Clinicians in Preventing Cervical Cancer

 Roche’s CINtec PLUS Cytology Test Receives the US FDA’s Approval to Aid Clinicians in Preventing Cervical Cancer

Roche’s CINtec PLUS Cytology Test Receives the US FDA’s Approval to Aid Clinicians in Preventing Cervical Cancer

Shots:

  • The approval is based on IMPACT trial, which enrolled ~ 35,000 women to clinically validate CINtec PLUS Cytology as a triage test in various screening scenarios. Publication of the full study findings is pending
  • The approval gives laboratories access to the complete Roche Cervical Cancer Portfolio in the US, including the cobas HPV Test, CINtec PLUS Cytology, and CINtec Histology. The approval allows the test to be set as triage for positive cobas HPV tests run on cobas 6800/8800 Systems in primary screening or co-testing programs
  • The CINtec PLUS Cytology test runs on the BenchMark ULTRA IHC/ISH system and is performed using the same sample that is used for HPV or liquid-based Pap cytology tests. The assay detects the simultaneous presence within a single cell of the two biomarkers (p16 and Ki-67) and a positive result signals that a woman is at risk for disease

Click here ­to­ read full press release/ article | Ref: Roche | Image: Follow the Money

Tuba Khan

Tuba Khan is an Editor and Digital Marketing expert at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in Lifesciences industry. She covers Pharma, Medical devices, Diagnostics and Digital health segment. Tuba also has an experience of digital and social media marketing and can run the campaign independently. She is also certified as a Digital marketer and social media marketer. She can be contacted on tuba@pharmashots.com

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