Despite FDA approval of at-home self-collection kits, 61% of women favor clinician-collected testing, signaling continued stability for traditional lab workflows.
A new national study suggests that while home-based cervical cancer screening is now an option in the United States, most women still prefer in-clinic testing—an important signal for clinical laboratories preparing for potential shifts in specimen volume and workflow.
Researchers at The University of Texas MD Anderson Cancer Center found that 60.8% of screening-eligible women prefer to undergo cervical cancer screening in a clinical setting rather than use an at-home self-collection kit. The findings, published in JAMA Network Open, come months after the Food and Drug Administration (FDA) approved the first home-based self-sampling device for cervical cancer screening, a move intended to expand access and improve uptake among under-screened populations.
Among 2,300 women aged 21 to 65 surveyed through the 2024 Health Information National Trends Survey , 20.4% said they would prefer at-home screening, while 18.8% were unsure. For laboratory professionals, the data suggest that while home-based human papillomavirus (HPV) testing may grow, traditional clinician-collected specimens are likely to remain the dominant source of cervical screening volume—at least in the near term.
For laboratories, the findings suggest that traditional clinician-collected Pap and HPV specimens are likely to remain the primary driver of screening volume in the near term, with home-based kits adding incremental growth rather than immediately shifting overall test mix.
Demographic Differences Point to a More Segmented Screening Market
The study also highlights important demographic differences that could shape outreach strategies and testing patterns. Women who were overdue for screening were more likely to prefer at-home kits, as were individuals who reported experiencing prejudice or discrimination in healthcare settings. Privacy (54.9%), time constraints (35.1%), and avoidance of embarrassment (33.4%) were the most commonly cited reasons for choosing self-collection.
However, Black women were less likely than White women to prefer at-home screening, a finding that underscores the need for culturally tailored education and engagement strategies. Women with lower incomes and those who reported distrust of the healthcare system were more likely to say they were uncertain about which screening option to choose.
For clinical laboratories, these nuances may translate into a more segmented screening market. Health systems and public health programs that deploy mailed self-collection kits could see incremental increases in HPV testing from previously unscreened patients. At the same time, uncertainty and limited familiarity with the newly approved devices—particularly since FDA approval occurred after the survey was conducted—suggest that adoption may be gradual.
“Home-based self-sampling has the potential to remove many of the barriers women face when it comes to cervical cancer screening,” said lead author Sanjay Shete, PhD, of MD Anderson’s Division of Cancer Prevention and Population Sciences. (Photo credit; MD Anderson)
Co-author Joël Fokom Domgue, MD, noted that national organizations such as the Health Resources and Services Administration and the American Cancer Society have already adopted home-based self-collection as part of their screening recommendations, and he suggested broader policy updates could help reduce inequities.
For laboratory professionals, the study underscores both opportunity and operational complexity: Expanding access through self-collection may boost overall screening rates, but in-clinic testing remains the clear preference for most women. Strategic planning around specimen logistics, patient education, and payer policies will likely determine how quickly—and how substantially—home-based screening reshapes the cervical cancer testing landscape.
Speakers at Frontiers in Laboratory Medicine See Increased Role for Pathology
DATELINE: BIRMINGHAM, ENGLAND—As our North American readers of Dark Daily arrive for work this morning, it will be late afternoon here in the United Kingdom and the last presentations on the second day of the 10th annual Frontiers in Laboratory Medicine (FiLM) will be wrapping up.
It was a packed auditorium this year at FiLM, as clinical biochemists, pathologists, and medical laboratory scientists gathered to learn about achieving best practices in pathology management and clinical laboratory operations. One reason for this heightened interest is the major reforms already cascading throughout the United Kingdom’s National Health Service (NHS).
Plans are to centralize all cervical cancer screening in just two Alberta medical laboratories
Ongoing efforts to further consolidate clinical laboratory testing in the Canadian Province of Alberta caused local pathologists earlier this year to go on record to specifically oppose a proposed consolidation of Pap Smear testing. Over the past 15 years, the Alberta government has never been timid in its efforts to use consolidation of clinical pathology laboratory testing as a way to achieve cost savings.
During the past winter, more than 30 pathologists in Alberta signed letters to Health Minister Gene Zwozdesky to protest the consolidation of all the province’s Pap Smear testing into just two clinical laboratories—one in Edmonton and one in Calgary. As a result of the government’s decision to consolidate this medical laboratory testing service, cytology laboratories in Lethbridge, Medicine Hat, Red Deer, and the University of Alberta Hospital would no longer perform Pap smear testing. (more…)
Because of HPV’s link to cervical cancer, and because cervical cancer screening is a major activity in the laboratory industry, big pharma efforts to make money from HPV-related products are worth watching. That’s because big pharma has the resources to powerfully influence public opinion and legislative action.
Here in Texas, home to Dark Daily and The Dark Report, it was big news last month when our Republican Governor, Rick Perry, bypassed the state Legislature and signed an order making Texas the first state to require that schoolgirls get vaccinated against HPV. Because HPV is considered a sexually-transmitted virus that causes cervical cancer, of course there were the usual public harangues about the moral implications of this order by folks from the right and from the left. Shortly thereafter, all the buzz died down.
But that’s not the end of the story, because Governor Perry’s order caused the media to look more deeply into why more than 20 state legislatures were actively considering bills to mandate HPV testing for school-aged children. How was it that so many state legislators were suddenly inspired to champion this cause, at almost the same time? It turned out that Merck & Co, the manufacturer of Gardasil, the only FDA-approved vaccine for HPV in the market, was supporting an active, behind-the-scenes lobbying program.
Within a couple of weeks after news stories made this connection public, Merck announced that it was suspending its support of programs designed to lobby state legislators in favor of laws to require HPV vaccinations of school-age children. There were numerous reasons for this suspension. Merck identified negative publicity as the primary one, but groups sighted potential damaging effects of the vaccine on young girls, the fact that this vaccine was quite different from other vaccines required by school systems (those vaccines are for diseases passed by casual contact), and a slew of other reasons. Doctors were happy to see the lobbying stop for another reason entirely, however.
Pediatricians and gynecologists nationwide are refusing to stock Gardasil, the HPV vaccine, because of its $360 price and “totally inadequate” reimbursement from most insurers. Pediatricians, in particular, are fed up after years of declining reimbursement for vaccines, an explosion of new vaccines, and fast-escalating vaccine prices. Vaccines pose a problem for practices because they tie up $50,000 or more in inventory, run multiple refrigerators, require vaccine insurance, and require inventory management. Practices also must absorb the cost of broken or wasted vials.
With insurance companies reimbursing just $2 to $15 over the $120 per dose (3 doses required for the whole vaccine) charged by Merck, most doctors have chosen to either not give the vaccine or to require a surcharge. Pediatrician Dr. Herschel Lessin pointed out on CNN that it was ironic that insurers wouldn’t give physicians an extra $25 to cover their costs, but they would spend tens of thousands if a patient developed cervical cancer without question.
The issue of coverage for HPV vaccination won’t disappear. That’s because GlaxoSmithKline expects regulatory approval for its own HPV vaccine, called Cerverix. When that happens, there will be two deep-pocketed pharma giants with an economic motive to increase the rate of HPV vaccination. For laboratory directors and pathologists, it is an opportunity to watch a business school case study play out in the real world. There will also be as-yet-undetermined, but direct, consequences to current cervical cancer screening guidelines. As a larger proportion of the female population is vaccinated for HPV, it will be necessary to revamp cervical cancer screening guidelines. That may eventually reduce the volume of Pap testing done annually in the United States.