An Alternative to the Pap Smear Is Here, No Speculum Required

For some women, getting a Pap smear is hell.

Since her early twenties, Kevinn Poree has suffered from chronic vaginal pain — pain that led her to scream in agony the first time a gynecologist tried to insert a speculum.

“I completely lost it,” Ms. Poree, 38, said. After the speculum was removed, she started “crying in the fetal position.”

Ever since, like many women, she has dreaded the cervical cancer screening test, which requires a patient’s legs to be held apart with stirrups and a cold metal device to be inserted vaginally, while a physician scrapes cells from the cervix.

Even when acute pain isn’t an issue, research suggests that, for many, Pap smears are uncomfortable, for a complex set of physical and emotional reasons.

“There are people who experience distress,” due to fear or embarrassment or a history of sexual trauma, said Karen Knudsen, the chief executive of the American Cancer Society.

Now, a handful of health care companies are preparing to introduce a new model for cervical cancer screening and prevention that would circumvent the speculum: self-collection, in which a woman swabs her vagina in the doctor’s office, using only a narrow swab that looks similar to the one used during a Covid test. Once the sample is collected, a lab would test it for the strains of human papillomavirus, or HPV, most likely to cause cervical cancer.

A key change in HPV screening has made the technique possible: Labs are now able to test using samples taken from the vaginal walls, as opposed to from the cervix itself.

In introducing self-collection, the United States will be following countries including Australia, Denmark, the Netherlands and Sweden, which have gradually introduced self-sampling for cervical cancer screening in recent years, with great success in its adoption.

Two decades of research suggest this method is as effective at preventing cervical cancer as traditional Pap tests for women 25 and older.

In May, the Food and Drug Administration approved self-collection tools from the pharmaceutical companies Roche and BD (Becton, Dickinson and Company) for use inside health care settings. Patients can test themselves in private and leave a sample with a health care provider, similar to when they provide a urine sample.

But representatives for the companies said the longer-term goal is at-home cervical cancer screening, in which a test is ordered by a health care provider, a woman collects a sample at home and then sends it to a lab for HPV screening. If the sample comes back positive, her provider would then advise on next steps.

While screening at home is now available in other countries, this method is still under F.D.A. review in the United States. It could gain approval by early next year.

For women who want to self-sample sooner, BD’s kits will likely begin shipping to medical facilities in September, and Roche’s will roll out later this fall, their spokespeople said. Both tests involve inserting a swab about three inches into the vagina.

Experts hope the tests — which will be covered by public and private insurance, and free at many federally funded clinics for women who are uninsured — will help reach the 30 percent of eligible women in the United States who do not get screened regularly, including those who avoid Pap smears due to discomfort. This screening gap results in thousands of preventable deaths from cervical cancer every year.

Self-sampling comes at a time when women are pushing back against culturally embedded beliefs that gynecologic and reproductive pain is something they have to simply endure. Along with advances in alleviating IUD pain and the side effects of menopause, women’s health companies are also designing more comfortable speculums for gynecological exams.

Erin Kobetz, the associate director for community outreach and engagement at the Sylvester Comprehensive Cancer Center in Florida, who has spent two decades studying cervical cancer self-sampling, described the new tests as having been “a long time coming.”

Why the Pap Has Endured

Despite being disliked by many women, the patient experience of having a Pap smear with a speculum and stirrups has remained largely unchanged since the 1940s, when the test — named for its inventor, the physician Dr. George Papanicolaou — became standard practice in the United States.

This is in part because it works, said Dr. Knudsen of the American Cancer Society. The introduction of the Pap smear reduced cervical cancer mortality by more than 70 percent in the 20th century, so from that perspective, she said, “the Pap smear is unquestionably a win.”

During a Pap smear, the doctor takes a sample of cells from the cervix, smears it onto a slide and sends it away to a cytologist, who looks for precancerous or cancerous cells. If the test comes back positive for abnormal cells, and the disease is still in its early stages, a physician can usually remove the affected area and stop the disease from progressing.

More recently, in many cases, samples taken during Pap smears are also tested for the strains of HPV most likely to cause cervical cancer. If an HPV test comes back positive for one of these strains, physicians will monitor the patient closely for precancerous cells over the following years. (If abnormal cervical cells are also detected, the patient may receive some level of treatment.)

Pap smears and HPV tests are especially effective at preventing cervical cancer because the disease progresses slowly, relative to many other cancers; it typically takes years to move beyond the precancerous stage.

Preventable Cervical Cancer Deaths Persist

Despite the Pap smear’s effectiveness, the drop in cervical cancer deaths has leveled off since 2008. In the United States, about 11,500 women are diagnosed with cervical cancer each year, and 4,000 will die from it.

Public health officials say many of these deaths are preventable — and due, in part, to the current testing protocol failing to reach millions. “The incidence has really sharply declined” thanks to the Pap smear, Dr. Kobetz said, but this decline “has not been experienced equitably.”

Women who live in rural areas without easy access to doctors tend to be under-screened, as do women with lower socioeconomic status and Black and Latina women. Women with insurance were four times as likely to have been screened in the previous year compared to those without insurance.

For many, the difficulty of taking time away from work and family responsibilities can be a barrier to getting the test, as can the struggle to find a doctor with whom they feel comfortable. And while self-screening in a medical clinic might address some of these issues, the ability to test at home is more likely to close screening gaps, experts said.

Cervical cancer disproportionately affects Black women, who are 30 percent more likely to develop the disease than non-Hispanic white women, and 60 percent more likely to die from it. Black women are also among the least likely to be screened.

This disparity comes with a measure of irony, said Keisha Ray, an associate professor of humanities and bioethics at UTHealth Houston, who studies the effects of institutional racism on Black people’s health. The speculum was invented by Dr. J. Marion Sims, the so-called father of modern gynecology who tested his invention on enslaved women in the pre-Civil War South.

This history has created a generations-old distrust of and anxiety around gynecologic procedures, she said, describing the racial disparities as being “connected to history, to politics, to culture, and economic factors, legal factors, scientific factors.”

Women’s health advocates hope that self-collection tests will eventually help to address these disparities.

Health in Your Own Hands

Researchers are still studying at-home screening in the United States to ensure that samples can be safely transported to labs by mail. And the F.D.A. recently awarded breakthrough device status to the Teal Health test kit, which could be used at home with a telehealth provider, accelerating its review.

“Since the 1950s, there’s been this assumption that anything about your body that has to do with reproductive health requires a gynecologist,” said Wendy Kline, a professor of the history of medicine at Purdue University and the author of a forthcoming book, “Exposed: The Hidden History of the Pelvic Exam.” This moment is a reminder, she said, that “actually, I do have some authority on my body and I can do this on my own.”

Experts told The New York Times that they are cautiously optimistic that broader screening via self-collection — in concert with more robust vaccination against HPV — could help the World Health Organization meet its goal of eradicating cervical cancer in the near future.

“This is the one cancer that we could eliminate in our lifetime,” Dr. Kobetz said. From the start of her career, she said, “I thought that I would work myself out of a job.”