BD announces industry-first CE marked assay for HPV screening

BD (Becton, Dickinson and Company) today 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.

“The goal of cervical cancer screening is simple but critical: to detect pre-cancer before it develops into cancer,” stated Dr. Jeff Andrews, vice president of Global Medical Affairs at BD. “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 cliniciani.”

At-home collection will help address the urgent public health challenge of reaching women who do not attend routine cervical cancer screening. Over half of all cervical cancers are diagnosed in women who have never been screened or have not been screened in the previous five yearsii, a situation that has been compounded by the recent global pandemic.

Persistent infection with HPV is the cause of virtually all cases of cervical canceriii. Current estimates indicate that every year in Europe, more than 61,000 women are diagnosed with cervical cancer and nearly 26,000 die from the disease,iv making cervical cancer the second-most common female cancer deaths in women aged 15 to 44 and the ninth-most frequent cancer among women overall.iii

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 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.

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 cancerv. 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 underscreened women; and to manage 90% of screen-positive women” by 2030vi.

“Adding HPV self-sampling to any cervical cancer prevention effort is close to a silver bullet; it’s simple, easy and safe for women, and equals doctor-collected samples in diagnostic quality,” said Jesper Bonde, PhD, Senior Researcher and Molecular Pathology Laboratory Manager, Hvidovre Hospital, Denmarkvii. “HPV self-sampling makes screening accessible to women who don’t participate in screening or have limited access to screening.”

He further added that, “Combining HPV self-sampling with extended genotyping allows for focus on those women at highest risk while not overtreating those at very low risk. 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 both by allowing risk stratification directly on the screening sample.”

Cervical cancer screening has been very effective at reducing morbidity and mortality from disease but participation in screening programs varies widely across the Europe ranging from 7.3% to complete coverageviii. Adding at-home collection as an option to screening programs has been demonstrated to increase participation.i

“There has been a considerable drop in cervical cancer screening due to COVID-19ix,” said Brooke Story, president of Integrated Diagnostic Solutions at BD. “As a woman, I can say that a fear of exposure to COVID has impacted my own preventive health behavior, so I recognize both professionally and personally the value of having an easy, convenient and private self-collection process for HPV screening available.” MB Bureau