FDA clears at-home HPV self-collection kit as study finds most women still prefer clinic screening
The FDA has cleared the Onclarity HPV Self-Collection Kit for at-home use, with availability by prescription expected in the coming months. A JAMA Network Open study found 61% of women still prefer clinic screening, while 20% prefer self-sampling at home.
The U.S. Food and Drug Administration has cleared the Onclarity HPV Self-Collection Kit for at-home use, potentially removing a barrier that prevents many women from receiving routine screening. The regulator also approved the BD Onclarity HPV Assay with extended genotyping for at-home use. The kit is expected to be available by prescription in the coming months and can be mailed directly to a patient's home, allowing them to collect a sample and mail it to a laboratory for processing.
Cervical cancer is largely preventable with regular screening and early detection of human papillomavirus, or HPV, the virus responsible for nearly all cervical cancers. The kit is tested with the BD Onclarity HPV Assay, which detects all of the high-risk, carcinogenic genotypes of HPV.
A study reported Feb. 6 in JAMA Network Open found that about 3 out of 5 women, or 61%, would prefer to keep seeing a medical professional at a clinic for their Pap smear, while only 1 in 5, or 20%, said they would prefer to self-sample at home. About 19% said they were not certain which they would prefer.
For the study, researchers analyzed data from a 2024 survey in which 2,300 women ages 21 to 65 were asked, “If you had choice, how would you prefer to do the cervical cancer screening test?” Results showed that Black women were 55% less likely to prefer at-home screening compared to white women. Women who had experienced prejudice or discrimination when getting medical care were nearly twice as likely to want at-home screening.
The most commonly reported reasons for preferring at-home screening were:
- privacy (55%)
- time constraints (35%)
- fear of embarrassment (33%)
Researchers said home-based self-sampling has the potential to remove many of the barriers women face when it comes to cervical cancer screening. They also said medical organizations could help boost the popularity of at-home testing by incorporating it as an option in their guidelines for cervical cancer screening.
Covered by private insurance, Medicaid and Medicare, the at-home kit could provide broader nationwide access to cervical cancer screening.