www.fdanews.com/articles/196225-roches-hpv-cervical-cancer-test-receives-fda-approval
Roche’s HPV Cervical Cancer Test Receives FDA Approval
March 12, 2020
Roche received the FDA’s approval for its CINtec PLUS Cytology test, a diagnostic that identifies HPV-positive women at risk of cervical pre-cancers.
The biomarker-based test is designed for women whose primary cervical cancer screening results test show the presence of HPV. It is used on Roche’s cobas 4800 HPV test.
The diagnostic enables clinicians to identify women who should undergo immediate further diagnostic procedures to prevent them from developing more advanced cervical disease.