FDA approves first at-home cervical cancer test in United States


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Summary

Less invasive test

The Food and Drug Administration approved the first at-home, self-administered test for cervical cancer. Performed with a swab, it is significantly less invasive than a traditional Pap test.

Screening matters

The Centers for Disease Control and Prevention said about 11,500 women are diagnosed with cervical cancer each year in the United States, and about two-thirds of them were not screened within the recommended interval.

Prevention is possible

A vaccine against HPV, the virus known to cause cervical cancer, is available, and the CDC recommends everyone get it at around 11 or 12 years old.


Full story

The Food and Drug Administration approved the first at-home cervical cancer screening tool in May. It gives women an alternative to Pap smears, which are invasive and can be painful or traumatic.

Teal Health’s “Wand” is a sponge-like tool that collects a sample by swabbing the vagina. By contrast, a Pap smear involves inserting a speculum and scraping cells from the cervix.

Experts say the self-administered test is about as accurate at detecting HPV as a Pap test. HPV is the virus known to cause cervical cancer.

Similar vaginal tests were approved in 2024, but only for use in medical offices.

Unbiased. Straight Facts.TM

Each year in the United States, about 11,500 women are diagnosed with cervical cancer, and about 4,000 die, according to the Centers for Disease Control and Prevention.

How do I get a test?

The tests can be ordered online through Teal Health’s website. Patients will then speak with a telehealth provider, collect their sample and mail it to be tested.

If the test comes back positive for HPV, Teal Health will refer the patient for an in-person doctor’s appointment. If it’s negative, no further screening will be needed for three to five years — the same interval that experts recommend for HPV testing.

The initial test kits will be mailed to patients in California next month before they become available in other states.

Teal Health has not posted a set price for the tests listed on its website. However, CEO and co-founder Kara Egan told The New York Times the company is working with insurers to secure coverage. Teal is also seeking donations to subsidize tests for uninsured patients.

Patients may use health spending accounts and flexible spending accounts to cover the cost of the test.

Why is regular HPV testing important?

According to the National Cancer Institute, about one in five U.S. women is overdue for cervical cancer screening. Cervical cancer has been identified as one of the top preventable causes of death in the United States. HPV is the leading cause.

About 11,500 U.S. women are diagnosed with cervical cancer each year, according to the Centers for Disease Control and Prevention.  The disease kills about 4,000 women in the United States annually.

A University of Alabama study found about two-thirds of cervical cancers are diagnosed in women who are not screened within the recommended interval of every three to five years.

What can I do to prevent cervical cancer?

Experts say the best way to prevent cervical cancer is by preventing HPV, which can be done with a vaccine. It’s given as a series of either two or three doses, depending on age at initial vaccination.

The CDC recommends the HPV vaccine at 11 or 12 years old, but it can be started as early as age 9.

Adults who have not gotten the vaccine are still eligible until they’re 26.

Michael Edwards (Video Editor) and Cassandra Buchman (Digital Producer) contributed to this report.
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Why this story matters

FDA approval of the first at-home cervical cancer screening tool may increase accessibility to testing and early detection, potentially reducing preventable cervical cancer cases and deaths.

Healthcare accessibility

The availability of an at-home cervical cancer screening tool can help reach more individuals who experience barriers to in-person screening, as noted by the National Cancer Institute's finding that one in five U.S. women is overdue for screening.

Technological innovation

The FDA-approved device, Teal Health's "Wand," uses a less invasive, self-administered method for HPV detection, which experts said is about as accurate as traditional Pap tests.

Preventive medicine

According to the Centers for Disease Control and Prevention, regular HPV testing and vaccination are vital strategies in preventing cervical cancer and reducing related deaths in the United States.

Get the big picture

Do the math

Pap tests are recommended every three years for women aged 21 to 65. Teal Health’s study found 94% of participants would prefer at-home collection if shown to be accurate, and 86% said it would make them more likely to keep up with screenings.

Global impact

At-home cervical cancer screenings are already available in countries like Australia and Sweden. The U.S. approval of such technology may signal broader acceptance and potentially inspire similar initiatives worldwide, especially in regions where access to women’s health services is limited. Improved global screening could reduce worldwide cervical cancer incidence and mortality over time.

Underreported

Few articles detail how the device will be distributed to rural or marginalized communities beyond the initial California launch or address potential challenges for those without stable internet access or health insurance. Strategies for ensuring follow-up care after a positive test are also seldom explored in depth.

Bias comparison

  • Media outlets on the left framed the FDA’s approval of the at-home cervical cancer test as a breakthrough in addressing healthcare inequities, using emotive language like “painful, crampy, traumatizing” to describe Pap tests and emphasizing the test’s role in reducing racial and socioeconomic disparities.
  • Not enough coverage from media outlets in the center to provide a bias comparison.
  • Media outlets on the right highlighted patient choice, convenience and telehealth integration, portraying the approval as a “win” for innovation and access while subtly expressing skepticism through phrases like “company says,” which introduces distance from regulatory authority.

Media landscape

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Key points from the Center

  • The FDA approved Teal Health's Teal Wand on May 9, 2025 as the first cervical cancer screening kit for at-home sample collection in the U.S.
  • This approval responded to low screening rates, as only one in four women receive regular cervical cancer tests despite CDC guidelines.

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Key points from the Right

  • The US Food and Drug Administration approved the Teal Wand, the first at-home self-collection device for cervical cancer screening, according to Teal Health.
  • The American Cancer Society supported the FDA's approval, noting it could increase regular screening among women, especially those lacking access to medical providers.

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