FDA approves self-tests for cervical cancer, as an alternative to the dreaded pelvic exam

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The U.S. Food and Drug Administration late Tuesday approved a new way for people to screen for signs of cervical cancer.

Patients using the new method will self-screen with a swab at the doctors office to test for the HPV virus, bypassing the need for doctors to perform invasive, often uncomfortable, pelvic exams.

"It's to reach women who traditionally haven't been reached," said Jeff Andrews, vice president of medical and scientific affairs at BD, one of the makers of the new method.

While the first tests are expected to be reserved for clinic use, BD plans to eventually offer an at-home option, Andrews said. Roche, another provider whose product was approved, also plans to consider an at-home option.

The new tests could be conducted in a doctor's office, a mobile clinic or a retail pharmacy, with the sample then sent to a lab. The clinician would follow up with results and next steps, Andrews said.

Both are expected to be available this summer.

Such expanded screening options, Andrews said, eventually "could eliminate cervical cancer in the U.S."

How it works

A medical provider would give the self-collection swab to the patient to take into the bathroom, similar to the routine of an in-office urine test.

The patient would then insert the cotton-swab-like test into the vagina and swirl it around three times. They would deliver the completed test back to the provider, to send to a lab for evaluation.

Patients hear results from their clinician, who may advise further testing if the results are abnormal. Additional testing could mean a clinician orders another self-collection, or if the lab detects potentially dangerous forms of HPV, a full pelvic exam and further testing may be conducted.

Both BD's Onclarity test and Roche's cobas test report on 14 strains of HPV.

Eliminating the risk of cervical cancer

Cervical cancer can be prevented and cured if caught early enough.

But the disease remains the fourth most common form of cancer among women globally, according to the World Health Organization. The WHO hopes to screening can be expanded worldwide by 2030, so that 70% of women are screened by the age of 35, and again by the age of 45.

In the U.S., most of the 13,000 new cases of cervical cancer diagnosed each year are among people who weren't screened in the previous five years, according to the U.S. Centers for Disease Control and Prevention. This presents an opportunity for new developments in screening, according to Andrews, especially among people at higher risk because they cannot regularly access gynecologic care.

"This cancer is unique," Andrews said. "The goal with other cancers is early detection and treatment. The goal with cervical cancer is to find pre-cancerous cells, treat them and never have cancer."

Treatment options depend on what type of precancerous cells are detected, the extent of severity and a person's medical situation, he said.

An alternative option to a pelvic exam

Most primary care doctors don't perform pelvic exams, meaning patients traditionally have to go to a gynecologist-obstetrician (OB-GYN) if they want to screen for cervical cancer.

With the self-collection option, more patients can screen for disease without having to book an additional appointment that costs time and money.

The cost of a self-screen will be the same as the pelvic exam, Andrews said, because the sample is sent to a lab, which charges for their pathology. Screening for cervical cancer is required to be covered by the Affordable Care Act, commonly called Obamacare, for those with insurance.

The arrival of a self-screening option doesn't replace the need for an annual OB/GYN visit which involves other aspects of reproductive health care. But it does mean that OB/GYN appointment could come with reduced anxiety about a pelvic exam.

"This is not to replace the role of an OB/GYN in your care," said Dr. Anne-Marie Amies Oelschlager, an OB/GYN professor at the University of Washington and chair of the clinical consensus gynecology committee at the American College of Gynecologists and Obstetrics (ACOG). "It doesn't take the place of being able to talk about contraception, to talk about whether you're in a safe relationship, to talk about your periods ... it doesn't take the place of breast cancer screening."

There are a lot of reasons why someone may want to avoid a pelvic exam at the OB/GYN if it's not medically necessary, Oelschlager said. People may have stress from a prior negative pelvic exam experience, feel pain in that area if they have a condition or be re-traumatized if they have a history of sexual abuse.

"Self-screening would be one way for them to have more control over what happens to them in that part of the exam," Oelschlager said.

She and other experts with ACOG have said patients should be involved in the decision whether to have a pelvic exam. For those without symptoms, such as a prior abnormal HPV test, vaginal discharge or pain in intercourse, pelvic exams may not necessary, Oelschlager said. "It's a way of figuring out who needs additional testing and who can safely wait before repeat testing."

Does this have anything to do with HPV vaccine?

The CDC first recommended vaccinating against the most common strains of human papillomavirus, the sexually transmitted virus that causes cervical cancer in 2006. Today, the CDC recommends all children receive the vaccine starting around age 11.

The vaccine was initially targeted at girls only, but has expanded to include everyone. Vaccinated boys can't pass HPV to partners with vaginas. Vaccination also protects against genital warts as well as throat and penile cancer, said Lonna Gordon, a doctor of adolescent medicine at Nemours Children's Hospital in Orlando, Florida.

And adults who didn't get the shot when they were younger can still get vaccinated, Oelschlager said.

Anyone who is vaccinated but has an unvaccinated partner is protected from the disease but should also keep up with regular cervical cancer screening: "The vaccine does not eliminate the need for a screening test," Gordon said.

A matter of inclusion

Cervical cancer screening is most often missed by people in rural areas and members of the LGBTQ community, Oelschlager said.

Because gynecological care is highly gendered, there are barriers to accessing this kind of care for people who don't identify as women, said Stephen Martin, assistant professor of gynecology and obstetrics at the Johns Hopkins University School of Medicine. These more translatable screening options have a high potential to diversify gynecology care, he said.

"The barriers begin with just walking in the door," Martin said, "In most gynecologists' offices, you're going to be potentially surrounded by [cisgender] women and pregnant women." In many places, the staff are not trained to provide gender-diverse care, Martin said, and gender identity can exacerbate the stress and emotion involved in receiving a pelvic exam.

Offering options like self-screening can build trust between providers and patients from marginalized communities, Martin said. "That way, even if an exam does need to be done, it's done with the patient, not on the patient."