Sept. 25, 2020—Roche announced FDA approval for the expanded use of CINtec Plus Cytology, a triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human papillomavirus. Laboratories can now use the test to triage positive results from the Cobas HPV test run on the high-throughput Cobas 6800/8800 systems.
“This expanded indication for CINtec Plus Cytology gives laboratories the flexibility to triage Cobas HPV test results on their choice of Cobas systems and deliver accuracy needed to reliably detect HPV infections that are starting to cause cellular changes that could lead to cancer,” Thomas Schinecker, CEO Roche Diagnostics, said in a press statement. “The biomarker information helps to clarify a woman’s risk of disease, reduce the potential for over or under treatment, and is a major step forward in individualizing a woman’s care.”
For U.S. approval, the FDA considered data from the Roche-sponsored registrational IMPACT trial, which enrolled approximately 35,000 women in the U.S. to clinically validate CINtec Plus Cytology as a triage test in various screening scenarios. Publication of the full IMPACT study findings is pending.