BD’s HPV assay for at-home self-collection obtains CE mark

25 May 2021


BD receives CE mark for its at-home self-collection claim for BD Onclarity HPV Assay. Becton, Dickinson and Company (BD) has received CE mark for its at-home self-collection claim for BD Onclarity HPV Assay for human papillomavirus (HPV) screening.

This approval will permit laboratories and facilities to process self-collected samples using a BD diluent tube with the HPV assay on BD Viper LT and BD COR Systems.

The assay can identify and distinguish 14 high-risk HPV types with a single analysis.

It can also deliver genotyping data from samples obtained for cervical cancer screening in the BD SurePath Collection Vial, Hologic PreservCyt Solution and Cervical Brush Diluent tube.

In addition to HPV genotypes 16, 18 and 45, the assay includes genotype reporting for types 31, 51, 52, 33/58, 35/39/68 and 56/59/66.

BD global medical affairs vice-president Dr Jeff Andrews said: “The goal of cervical cancer screening is simple but critical: to detect pre-cancer before it develops into cancer.

“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.”

The company noted that at-home collection helps address the public health challenge of testing women who do not routinely get screened for cervical cancer.

If left untreated, HPV infections cause almost all cervical cancer types. Estimates show that more than 50% of cervical cancers are detected in women who were never tested or not screened in the last five years.

BD said that the addition of an at-home collection option to screening programmes has shown a surge in participation.

Earlier this week, BD reported revenues of $4.9bn in the second fiscal quarter, ended 31 March, representing an increase of 15.4% on a reported basis, compared with $4.25bn in the same period last year.

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