A recent publication froma large European clinical study that included >40,000 women aged 25-46, was evaluated the accuracy of cytology, HPV E6/E7 mRNA and p16/Ki-67 as triage tests and the performance of these tests to predict CIN2+ regression and virus clearance at the 1 year time point.1 HPV DNA-positive women were triaged with cytology and […]
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 CERvical Tissue AdjunctIve aNalysis (CERTAIN) study was one of the largest immunohistochemistry (IHC) studies to date. It analyzed the impact of adjunctive use of p16 IHC on diagnostic sensitivity and specificity for ≥CIN2 when p16 IHC was used according to the LAST recommendations.1 The study set included 1.100 cervical biopsies representative of a U.S. […]
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 […]
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 […]