Dive Brief:
- BD said Wednesday it has received Food and Drug Administration approval for a kit for self-collection of specimens for human papillomavirus (HPV) testing.
- The approval allows people self-collect vaginal specimens in healthcare settings when cervical samples cannot otherwise be obtained.
- BD said the approval could allow people to collect their own samples in non-traditional settings such as retail pharmacies and mobile clinics, potentially improving access to screening.
Dive Insight:
Almost all cases of cervical cancer are HPV positive. Public health officials have identified HPV screening as part of a strategy for eliminating cervical cancer. In 2021, 72% of women aged 21 to 65 in the U.S. were up to date with cervical cancer screening. Officials want to increase the figure to over 84% by the end of the decade.
BD sees self-collection as a way to increase screening rates. Patients can use BD’s newly approved device to collect samples for testing with its Onclarity HPV Assay. The assay enables screening without a traditional Pap smear performed with a speculum tool.
Jeff Andrews, vice president of global medical affairs for diagnostic solutions at BD, said in a statement that “many patients are uncomfortable with the intimate nature of a pelvic exam.” Other people live in areas without a local doctor or clinician trained to obtain a sample with a speculum, Andrews said. The self-collection option could enable them to get screened despite such barriers to testing.
The approval allows people to self-collect vaginal specimens in a healthcare setting, including locations such as retail pharmacies. Some countries people women to collect samples at home, and BD has found an appetite for that option in the U.S.
BD and Harris Poll assessed attitudes to self-collection in a survey of women in the U.S., U.K. and Sweden and published their results in January. The survey found 56% of women in the U.S. said they would be comfortable doing a self-collected vaginal test at home to screen for cervical cancer. Two-thirds of U.S. respondents said they would be interested in at-home screening for HPV or cervical cancer.
“Reasons given include being more comfortable in the privacy of their own home, having the ability to administer the test themselves (without a doctor) and not having to make time through an appointment to see a health care practitioner,” BD said. “Notably, younger women are more likely to be interested in self-collection across all three geographies surveyed.”
Countries including Denmark, Sweden, the Netherlands, Kenya, Australia and New Zealand allow people to collect their own samples. Sweden began posting self-collection kits to homes in the pandemic. After sending 330,000 self-sampling kits to homes around the capital city, population test coverage increased from 75% to 85% in one year.