BD announces CE marked assay for HPV screening from at-home self-collected samples

May 13, 2021  –  BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) 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.

At-home collection will help address the urgent public health challenge of reaching women who do not attend routine cervical cancer screening, the company says.

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. The BD Onclarit 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.

Persistent infection with HPV is the cause of virtually all cases of cervical cancer. In late 2020, the World Health Organization (WHO) launched its Global Strategy to Accelerate the Elimination of Cervical Cancer, recognizing the potential for a three-pronged approach of vaccination, screening, and treatment to virtually eliminate cervical cancer.

The European Union has set a goal to introduce “organized population-based HPV-based screening and achieve 70% of screening coverage in the target age group, specifying HPV testing of self-samples for non-screened or under-screened women; and to manage 90% of screen-positive women” by 2030.

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