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TEST:
cobas® HPV test

Company:
Roche
Type:
FDA Approved (PMA)
Related tests:
Evidence

News

14d
Journal • Head-to-Head
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cobas® HPV test
19d
Comparison of Whole-Viral Genome Sequencing and PCR-based assay for Anal HPV Detection to Inform Clinical Implementation. (PubMed, J Virol Methods)
In addition, WGS-based identification of HPV16 sub-lineages demonstrated that the composite A1, A2, A4, and C1 sub-lineages were associated with a higher risk of abnormal cytology compared to other HPV16 sub-lineages. WGS can further delineate the natural history of anal HR-HPV and their sub-lineages in populations at high-risk for HPV acquisition.
Journal
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cobas® HPV test
26d
Performance of a New Brazilian Self-Sampling Device for High-Risk Human Papillomavirus Screening. (PubMed, Asian Pac J Cancer Prev)
The COARI® self-sampling device demonstrated reliable and effective performance for hrHPV detection and partial typing, showing strong potential to increase access to and coverage of cervical cancer screening in Brazil. Further studies with larger and more diverse populations are needed to validate these findings and inform public health implementation.
Journal
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cobas® HPV test
1m
HPV Vaccination and HPV Outcomes After LEEP: A Retrospective Population-Based Cohort Study from Northern Norway, 2022-2024. (PubMed, Vaccines (Basel))
HPV vaccination before the first post-treatment follow-up was associated with lower HPV positivity after LEEP. As this outcome is a surrogate endpoint and residual confounding is possible, studies with standardized follow-up and long-term clinical endpoints are needed.
Retrospective data • Journal
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cobas® HPV test
1m
High throughput HPV genotyping by next generation sequencing for detection of 28 HPV types and 13 sexually transmitted infections: A first community-based cervical cancer screening study from India. (PubMed, Diagn Microbiol Infect Dis)
A substantial proportion of women with abnormal cytology in this community cohort harboured non-HPV16 and HPV18 high-risk infections, highlighting the importance of extended HPV genotyping. NGS-based HPV genotyping was concordant with the comparator assay used and had simultaneous STI identification, supporting its potential utility as a comprehensive tool for community-based cervical cancer screening and risk stratification.
Journal • Next-generation sequencing
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cobas® HPV test
2ms
Advancing Cervical Cancer Screening Through the Emergency Department - IIS (clinicaltrials.gov)
P=N/A, N=200, Active, not recruiting, University of Rochester | Recruiting --> Active, not recruiting
Enrollment closed
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cobas® HPV test
2ms
Comparative efficacy, feasibility and acceptability of HPV DNA testing on first-void urine versus self-collected vaginal samples: a real-world study in a resource-limited setting. (PubMed, BMJ Glob Health)
HPV testing using FVU demonstrates high agreement with vaginal self-sampling, comparable accuracy in detecting CIN2+ lesions and greater acceptability among women. This method is feasible and well-suited for cervical cancer screening in resource-limited settings.
Clinical • Journal • Real-world evidence
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cobas® HPV test
2ms
Evaluation of Cycle Threshold (Ct) Values for Detecting High-Risk HPV in Self-Collected Vaginal Samples as a Triage Method to Colposcopy. (PubMed, Diagnostics (Basel))
For self-collected vaginal samples of hrHPV-positive women, the Ct value may be used as a triage method to colposcopy. As Ct values inversely reflect the viral loads, they are lower in high-grade CIN and/or carcinoma.
Journal
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cobas® HPV test
2ms
Performance of a novel, urine-based test for the detection of cervical human papillomavirus infection. (PubMed, J Clin Microbiol)
By simplifying and standardizing urine collection and by expanding access beyond traditional clinical settings, this technology has the potential to increase uptake of HPV screening programs by overcoming barriers associated with invasive sampling methods and thereby reduce inequities. More importantly, these methods can contribute to earlier detection and prevention of cervical cancer.
Journal
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cobas® HPV test
2ms
HPV Screening in Women Living with HIV (WLHIV) in Karnataka, India: Can it be Integrated into ART Centres? (PubMed, Asian Pac J Cancer Prev)
The study confirms the significant burden of cervical neoplasia in WLHIV and demonstrates the feasibility and importance of integrating HPV screening and 'see and treat' services within or near existing ART centres using portable technologies. Leveraging the extensive NACP network offers a strategic opportunity for nationwide implementation, crucial for cervical cancer elimination efforts in this high-risk population.
Journal
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cobas® HPV test
3ms
Follow-up of Women Testing Positive for Human Papillomavirus Non-16/18 With Normal Cytology in a Screening Context. (PubMed, J Low Genit Tract Dis)
Women with HR HPV non-16/18 and normal cytology represent a high-risk group requiring long-term follow-up. No malignancies were observed in the first year of follow-up, supporting the recommendation for retesting after 12 months and colposcopy referral if the infection persists.
Journal
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cobas® HPV test
4ms
Expanding access to cervical cancer screening: the performance of self-sampled urine HPV testing. (PubMed, Int J Infect Dis)
Urine-based HPV testing using a DNA purification and concentration process is non-inferior to the gold standard Cobas4800 test on provider-collected samples for the detection of high-risk HPV types and the high grades of cervical precancerous lesions. The Experimental Test provides a highly sensitive, reliable, and scalable option for cervical cancer screening, particularly in settings where traditional screening methods are less accessible.
Journal
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cobas® HPV test