Entries by Kaja Čop

Clinical validation of p16/Ki-67 Dual-stained cytology triage of HPV-positive women: Results from the IMPACT trial

The landmark IMPACT (IMproving Primary screening And Colposcopy Triage) trial was a cervical cancer screening study designed to clinically validate and support the FDA approval of tests in Roche Cervical Cancer Portfolio – CINtec®  PLUS Cytology, a dual-stain biomarker-based test, and the cobas® HPV test for use on the cobas®  6800/8800 Systems. In May 2021 first […]

The IMPACT trial: IMproving Primary screening And Colposcopy Triage

The landmark IMPACT trial was a cervical cancer screening study designed to clinically validate and support the FDA approval of tests in Roche Cervical Cancer Portfolio – CINtec® PLUS Cytology, a dual-stain biomarker-based test, and the cobas® HPV test for use on the cobas® 6800/8800 Systems. The IMPACT trial was a multi-center, prospective trial that included >35.000 women aged 25–65 years […]

SARS-CoV-2 antibodies detected in human breast milk post-vaccination

Importance The SARS-CoV-2 pandemic has infected over a hundred million people worldwide, with almost 2.5 million deaths at the date of this publication. In the United States, Pfizer-BioNTech and Moderna vaccines were first administered to the public starting in December 2020, and no lactating women were included in the initial trials of safety/efficacy. Research on SARS-CoV-2 […]