BD Secures European Approval for At-Home HPV Testing Kit to Enhance Cervical Cancer Screening Access

Compiled & Translated by | Keke

To help detect more cases of cervical cancer and precancerous lesions before they progress and spread, Europe has approved the at-home human papillomavirus (HPV) testing device from BD, a medical technology and equipment company.

Among all cervical cancer patients, more than half had never undergone screening or missed their tests within the past five years. Since nearly all cervical cancers are caused by human papillomavirus (HPV), routine screening is therefore critical to preventing a largely preventable disease.

This new marketing approval expands the indicated use of BD’s laboratory-based Onclarity HPV assay to include self-collected vaginal swab specimens mailed in for analysis. The new approval encompasses the use of BD’s collection vials and the sample preservation solution provided by Hologic, reflecting the increased value placed on at-home diagnostic testing under various conditions during the COVID-19 pandemic.

BD’s genomic sequencing assay, approved by the U.S. FDA last July, is capable of identifying 14 distinct HPV strains to help identify women who may be at the highest risk of developing cervical tumors. HPV infection causes nearly all cervical cancer cases worldwide.

HPV genotypes 16 and 18 alone account for over 70% of cancers and precancerous lesions; however, if detected early, both are treatable. Other U.S. companies, such as home diagnostics provider Everlywell, have also launched self-collected HPV tests, but they test for fewer HPV genotypes.

Jeff Andrews, Vice President of Global Medical Affairs at BD, stated: “Self-collection not only provides women with greater access to testing, but also gives them the confidence that HPV testing on self-collected samples is just as reliable as testing on samples collected by a clinician.”

Late last year, the World Health Organization launched a global strategy aimed at eliminating cervical cancer, calling for a three-pronged approach comprising HPV vaccination, screening, and treatment. Meanwhile, the European Union has set a target to achieve 70% screening coverage among the age groups most susceptible to cervical cancer, including through self-sampling.

Source: BD scores European approval for at-home HPV testing, as COVID lockdowns dent cervical cancer screening rates