March 26, 2020—Roche announced FDA approval of CINtec Plus Cytology, a biomarker-based triage test for women whose primary cervical cancer screening results are positive for human papillomavirus using the Cobas 4800 HPV test.
CINtec Plus Cytology provides definitive information about which HPV-positive women may benefit most from immediate referral to colposcopy versus repeat testing. The dual-stain biomarker technology included in the test detects the simultaneous presence of p16 and Ki-67 within a single cell. The test can be performed using the same liquid sample that is used for HPV or Pap cytology testing. Primary screening by the Cobas 4800 HPV DNA test with triage using the CINtec Plus Cytology test demonstrated high sensitivity and specificity to detect transforming HPV infections.
“Despite being nearly 100 percent preventable, cervical cancer is still one of the most common cancers in women worldwide. To address this, Roche is dedicated to investing in next-generation biomarkers that will significantly advance screening strategies and support global efforts to eradicate this disease,” Thomas Schinecker, CEO of Roche Diagnostics, said in a press release.
The CINtec Plus Cytology test runs on the BenchMark Ultra IHC/ISH system and is expected to be commercially available in the U.S. later this year.