cobas® HPV tests run on cobas® Systems, based on Nobel prize-winning PCR technology. cobas® Systems enable consolidated assay menu, backed by extensive experience and expertise in test design and optimization. cobas® Systems deliver full automation, increased throughput and faster turnaround time, providing users with greater flexibility to increase overall workflow efficiencies. The broad menu includes assays for viral load monitoring, donor screening, women’s health and microbiology/other STI screening.
Our commitment to robust standards demonstrates an unparalleled dedication to thorough data analysis and validation, so that you can have the utmost confidence in every result. Click here to learn more about our continued investment in new assay solutions and expanded menu offering.
The IMPACT (IMproving Primary screening And Colposcopy Triage) trial is a landmark cervical cancer screening study that was designed to support the FDA approval of multiple products, including CINtec® PLUS Cytology and the cobas® HPV test for use on the cobas® 6800/8800 Systems. The multi-center, prospective trial enrolled close to 35,000 women in the U.S. and is representative of the routine cervical cancer screening population.
In April 2020, the FDA approved the cobas® HPV test for use on the cobas® 6800/8800 Systems. Previously, in 2011 it was FDA approved for use on only the cobas® 4800 System. The cobas® HPV test is approved for primary HPV screening in women 25 and older, as a reflex (follow-up) test for ASC-US (Atypical Squamous Cells of Undetermined Significance) Pap cytology results in women 21 and older, and as a co-test with Pap cytology for women 30 and older using ThinPrep PreservCyt Solution.
While most HPV infections resolve on their own, some women who test positive for the virus or whose co-testing results are inconclusive – HPV-positive and Pap cytology-negative – may develop pre-cancerous cervical lesions that, if left untreated, may progress to cervical cancer. Early identification of women who are most at risk is vital. The IMPACT trial also clinically validated CINtec® PLUS Cytology, which received its first FDA approval in March 2020. CINtec® PLUS Cytology is a dual-stain test that uses biomarker-based technology to detect the simultaneous presence of p16 and Ki-67 within a single cell. This abnormality is associated with HPV infections that are transforming and can, if left untreated, progress to pre-cancer or cancer. A positive result of these two biomarkers in a single cell signals that a woman is more significantly at risk for disease.
Study data will be broadly shared, pending publication of the key findings.
The ATHENA HPV trial was a large, prospective clinical study evaluating the performance of the cobas® HPV test in three relevant populations*: women with ASC-US (Atypical Squamous Cells of Undetermined Significance) cervical cytology (≥21 years), women with normal cervical cytology (≥30 years), and an overall screening population (25+ years) to explore HPV as a first-line test (ongoing longitudinal 3 year study).[1, 2, 3, 4] ATHENA, with over 47,000 women enrolled, also set out to evaluate the medical value of testing for pooled hrHPV DNA as well as genotypes HPV 16 and HPV 18 individually.
*Women <25 years (n=4,183) with normal cytology exited the study.
The cobas® HPV test was clinically validated in ATHENA, the first screening trial for registration that evaluated simultaneous real-time genotyping of 12 pooled hrHPV genotypes plus HPV 16 and HPV 18 individually. The ATHENA trial evaluated the performance of the cobas® HPV test in multiple clinical situations, including ASC-US triage and co-testing (HPV and Pap cytology).
ATHENA not only validated the cobas® HPV test as comparable to the current standard of pooled hrHPV testing within the ASC-US population, but the trial also quantified risk of precancer and cervical cancer in HPV 16+ and/or HPV 18+ women who had ASC-US or who had normal cytology.
The ATHENA study demonstrated that one in four women who are HPV 16 positive will have cervical disease within three years and that nearly 1 in 7 women with normal Pap cytology who were HPV 16 positive actually had high-grade cervical disease that was missed by cytology.
In addition, results from the ATHENA trial included a comparison of a cobas® HPV test screening strategy to alternative strategies using Pap cytology and HPV testing. The comparison showed that a strategy leveraging the ability of the cobas® HPV test to identify women testing positive for HPV 16 or 18, and using cervical cytology (Pap) as a triage, follow-up test, would allow clinicians to detect more disease without referring a significantly greater number of women to unnecessary follow-up. In 2014, based on ATHENA study data, the U.S. FDA approved for the first time the use of the Roche cobas® HPV test instead of Pap cytology for first-line primary screening in women 25 and older.
The CERTAIN Study included:
As a result of the CERTAIN Study, CINtec® Histology achieved ≥ 99% acceptability for staining, morphology, and background. In addition, the CERTAIN Study led to CAP (College of American Pathologists), the ASCCP (American Society for Colposcopy and Cervical Pathology) and WHO (World Health Organization) recommending the adjunctive use of p16 IHC in evaluation of cervical biopsies. Learn more by accessing our training module on CINtec® Histology-CERTAIN Study.
Many published articles and papers support the advancement of science around HPV and cervical cancer prevention. The science behind HPV and its role in disease progression has opened up new pathways for patient management and care. Please see below for a summary of clinical study publications that have been significant in shaping and supporting today's understanding to guide clinical practice.