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Becton Dickinson Gets CE Mark for At-Home Self-Collected HPV Test Indication

NEW YORK – Becton Dickinson announced on Thursday that it has obtained CE mark for an assay for human papillomavirus with an at-home self-collection indication.

Labs using BD's HPV screening test in countries that accept the CE mark can now use samples that are self-collected by patients at home into appropriate BD collection vials. These samples can then be assessed using the PCR-based BD Onclarity HPV assay on the BD Viper or BD Cor molecular diagnostics systems.

The Onclarity test performs extended genotyping of the HPV virus that causes almost all cases of cervical cancer, including 14 high risk types. Specifically, it detects and distinguishes high risk HPV genotypes 16, 18, and 45 as well as types 31, 51, 52, 33/58, 35/39/68 and 56/59/66.

"Not only does self-collection afford women greater access to testing, but they may also feel confident that the reliability of HPV testing of self-collected samples is the same as if they went to a clinician," said Jeff Andrews, VP of global medical affairs at BD, in a statement.

The firm noted that an estimated 61,000 women are diagnosed with cervical cancer and 26,000 women die from the disease each year in Europe.

The ability to self-collect a sample at home can help reach women who do not attend routine cervical cancer screening, BD said, noting that more than half of all cervical cancers are diagnosed in women who have never been screened or have not been screened in the previous five years. This has been compounded by the COVID-19 pandemic, the firm noted, citing a recent study suggesting the pandemic could be the tipping point for wider adoption of cervical cancer screening self-sampling.

Jesper Bonde, a researcher and molecular pathology laboratory manager at Hvidovre Hospital in Denmark, commented that combining HPV self-sampling with extended genotyping allows a focus on women at highest risk while not overtreating those at low risk.

Furthermore, "Screening strategies, including at-home self-collection, that employ HPV tests with simultaneous genotyping offer a simple way to improve cervical cancer screening to the benefit of the woman and health care providers ... by allowing risk stratification directly on the screening sample," Bonde said.

The BD Onclarity assay was initially CE marked in 2014 and granted premarket approval by the US Food and Drug Administration in 2018. The firm has expanded the number of viral strains covered as well as the types of collection methods that can be used. Earlier this year the firm indicated it expects to launch the BD Cor instrument in the US in 2021.