The U.S. Food and Drug Administration (FDA) has approved primary human papillomavirus (HPV) self-collection for cervical cancer screening in healthcare settings, a significant advancement that could expand access to early detection for millions of women and people with a cervix.
The approval enables patients to use a collection kit to take their own vaginal sample for HPV testing, offering a more convenient and private alternative to traditional screening methods that require a pelvic examination.
"Almost all cervical cancers are caused by persistent infection with certain types of HPV," said Dr. Karen E. Knudsen, CEO of the American Cancer Society (ACS). "Self-collection can expand access to screening and reduces barriers, which will give more people the opportunity to detect, treat, and ultimately survive cancer."
Addressing a Critical Gap in Screening
Despite the proven benefits of cervical cancer screening, current statistics reveal that approximately 28% of eligible women in the United States are not up-to-date with recommended screening. Public health officials aim to increase screening rates from the current 72% to over 84% by 2030.
"Most cervical cancers are found in people who have never had a cervical cancer screening test or who have not had one recently," explained Dr. William Dahut, chief scientific officer at the American Cancer Society. "That's why adding self-collection in a health-care center as a screening method for this potentially deadly disease can make a huge impact."
The American Cancer Society currently recommends cervical cancer screening begin at age 25 for women and people with a cervix. Those aged 25 to 65 should have a primary HPV test every 5 years, with the primary HPV test being the preferred screening method.
BD's Self-Collection Technology
BD (Becton, Dickinson and Company) announced it has received FDA approval for its self-collection kit designed for HPV testing with the company's Onclarity HPV Assay. This approval specifically allows for self-collection of vaginal specimens in healthcare settings when cervical samples cannot otherwise be obtained.
The approval extends to non-traditional healthcare settings such as retail pharmacies and mobile clinics, potentially improving access to screening for underserved populations and those in areas with limited healthcare resources.
Jeff Andrews, vice president of global medical affairs for diagnostic solutions at BD, highlighted the barriers that self-collection could help overcome: "Many patients are uncomfortable with the intimate nature of a pelvic exam." He added that some people live in areas without local healthcare providers trained to obtain samples using a speculum, making self-collection a valuable alternative.
Patient Preferences and Future Directions
A recent survey conducted by BD and Harris Poll revealed significant interest in self-collection options. According to the survey, 56% of women in the U.S. said they would be comfortable performing a self-collected vaginal test at home to screen for cervical cancer, and two-thirds expressed interest 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 reported. The survey also found that younger women across all surveyed regions showed greater interest in self-collection options.
While the current approval is limited to healthcare settings, the strong patient preference for at-home testing suggests potential future developments in this direction, similar to practices already established in some other countries.
Scientific Validation
Self-collection for HPV testing has been studied for over two decades and has demonstrated feasibility, acceptability, and comparable accuracy to clinician-collected samples. The method enables primary HPV testing without requiring a traditional Pap smear performed with a speculum tool.
This approval represents a significant step toward eliminating cervical cancer through improved screening rates, particularly among populations that have historically faced barriers to traditional screening methods. By providing a more accessible and comfortable option, healthcare providers hope to detect more cases at earlier, more treatable stages.
