23rd June 2021 Product update: rapidvirology staff writer
Industry-First CE-IVD Assay for HPV Screening At-Home Self-Collected Samples
BD (Becton, Dickinson, and Company) has announced the industry's first self-collection claim for HPV screening has been CE-marked to the IVD directive 98/79/EC.
The new claim allows laboratories and facilities to process self-collected samples via a BD diluent tube using the BD Onclarity™ HPV Assay on either the BD Viper™ LT or the BD COR™ System. The BD Viper™ LT is in use globally and the BD COR™ System, launched last year, is in use across Europe.
BD Onclarity™ HPV Assay
The BD Onclarity™ HPV Assay detects and identifies 14 high-risk human papillomavirus (HPV) types in a single analysis and provides genotyping information from specimens collected for cervical cancer screening purposes in the BD SurePath™ Collection Vial and in the Hologic PreservCyt® Solution (not approved in the United States), as well as in the Cervical Brush Diluent tube (not approved in the United States). The BD Onclarity™ HPV Assay includes genotype reporting beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68, and 56/59/66.
The assay is for use in accordance with clinical guidelines and within the scope of local regulatory authorizations as part of a comprehensive approach to cervical cancer screening. The BD Onclarity™ HPV Assay has FDA approval for clinical use in cytology-based screening with ASC-US triage, in co-testing paradigm, and in primary HPV screening. BD Onclarity™ HPV Assay has FDA approval for use in vaccinated women.
As the previously vaccinated subpopulation ages, the screening population will progressively include women with reduced prevalence of HPV 16 and 18, increasing the value of extended genotype reporting in a mixed population of vaccinated and unvaccinated women.
Date Published: 23rd June 2021
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Note: This content has been edited by a rapidvirology.com staff writer for style and content.