Cervical cancer is largely preventable, yet nearly 30% of eligible people with a cervix in the U.S. do not receive screening at recommended intervals. For many, the barrier isn’t just a lack of insurance or a provider; it is the pelvic exam itself.
FDA Approvals and the Shift to Self-Collection
The U.S. regulatory landscape for cervical cancer screening shifted in two distinct phases. In May 2024, the FDA expanded approvals for two tests—the BD Onclarity and Roche cobas platforms—allowing patients to collect their own vaginal samples using a swab or brush within a health care setting, such as a pharmacy, mobile clinic, or primary care office.
Singapore and U.S. Trials: Measuring the Impact on Uptake
Recent data suggests that offering a choice in how a sample is collected directly correlates with higher participation rates. A randomized controlled trial in Singapore involving 650 women aged 30 to 69 found that screening uptake reached 56.6 percent in the group offered self-collection if they declined a clinician exam, compared to 42.8 percent in the usual-care group.
The impact on detection was even more pronounced. The intervention group showed a high-risk HPV detection rate of 3.1 percent, while the usual-care group was only 0.3 percent. Crucially, seven of the 10 high-risk cases were found in women who had never been screened before, and five of those were identified specifically through self-sampling.
In the U.S., researchers at the University of Washington targeted a population that frequently avoids routine medical care: women at an outpatient opioid treatment program. The results indicated a high level of acceptance, as 90.8 percent of eligible patients agreed to self-collect their samples in the program’s restroom.
| Metric | Singapore Trial (Intervention) | Singapore Trial (Usual Care) | U.S. Opioid Clinic Trial |
|---|---|---|---|
| Screening Uptake | 56.6% | 42.8% | 90.8% (of eligible) |
| High-Risk HPV Detection | 3.1% | 0.3% | 30 patients total positive |
The “Follow-Up Gap” and Clinical Limitations
While self-collection removes the barrier to the initial test, it does not solve the challenge of subsequent care. An HPV test is a signal, not a diagnosis; positive results require a colposcopy or repeat testing to prevent cancer. In the University of Washington study, only 16 of the 30 patients who tested positive for HPV actually participated in follow-up care. Roughly half of the positive cases remained unaddressed.
This gap highlights a critical tension in public health: increasing the number of people screened is only effective if those people can then navigate the healthcare system for necessary treatment. Without follow-up, the increased detection rates provided by self-sampling do not automatically translate into fewer cancer cases or deaths.
BD Onclarity and the Future of At-Home Testing
Industry players are now pushing for a more seamless integration of home-to-lab logistics. On July 31, 2025, BD (Becton, Dickinson and Company) submitted an application to the FDA for a new at-home HPV test. This proposed system utilizes a swab the size of a Q-tip and a fully automated laboratory process called the BD COR™ System, which eliminates the need for manual sample preparation by technologists.
The BD Onclarity™ Assay is designed to report more individual high-risk strains of HPV than other available tests, a feature BD claims is essential due to the shifting prevalence of genotypes beyond HPV 16 and 18.
The SHIP Trial and National Scaling
A central component of this effort is the SHIP (Self-collection for HPV testing to Improve Cervical Cancer Prevention) Trial Network, launched in early 2024. With 25 clinical sites across the country, the SHIP trial is specifically designed to test if home-based collection performs as effectively as clinician-led collection across diverse socioeconomic and racial groups.
