FDA Approves Home Kits for HPV and Cervical Cancer Screening: What You Should Know

By: Krysten Brenlla and Lydia A. Fein, MD, MPH

The U.S. Food and Drug Administration (FDA) recently approved a new way for women to test for human papillomavirus (HPV), a viral sexually transmitted infection (STI) that can affect different parts of the body.

What’s HPV?

HPV is the most common STI in the United States, affecting approximately 14 million people each year. There’re more than 100 types of HPV, including strains that can cause warts on your hands, feet, and genitals. Other strains are more serious and higher risk, which can lead to cervical, vulvar, or vaginal cancers in women.

However, early detection is key and can be done with a pap smear or HPV testing. Now, with new federally approved guidelines, you can test yourself at home.

What’s the updated guidance?

According to the Centers for Disease Control and Prevention, nearly 4,000 women in the United States die every year from cervical cancer, and more than 13,000 new cases are diagnosed. But over the last 50 years, with early detection, prevention, and treatment, deaths have declined by more than 50 percent in the U.S., according to the American Cancer Society.

The Health Resources and Services Administration released new cervical cancer screening guidelines that now include at-home screening:

• For women ages 30 to 65, the new guidelines recommend that they receive a high-risk HPV test, which checks for the virus types most likely to cause cervical cancer, every five years as the preferred screening method. The sample can be collected at home (with the FDA-approved screening device), or at your doctor’s office. Women in this age group also have the option to combine the high-risk HPV test and pap smear every five years, or receive a pap smear every three years.
• For women ages 21 to 29, the recommended guideline is to receive pap smears every three years.

How can you test at home?

The new FDA-approved device, called The Teal Wand by Teal Health, works like a tampon. It allows women to collect their own sample at home and then send it to a laboratory for testing within 24 hours. The company then shows them their results through a portal, and if needed, provides virtual support. Although this at-home option is an alternative to cervical cancer screening in your doctor’s office, it must still be ordered by your healthcare provider, who will review your results and recommend any additional testing. Access to the self-collecting test also varies by insurer and plan.

While the test is meant to help women regularly test for high-risk HPV at home and in a comfortable setting, it shouldn’t replace regular gynecological visits, check-ins with your doctor, or pap smears.

“Undergoing routine cervical cancer screening is something women can do to prevent cervical cancer,” said Lydia A. Fein, MD, MPH, an obstetrician-gynecologist at Jackson Health System/UHealth – University of Miami Health System. “There are so many women who may not have access to screening or tests, which puts them at increased risk of developing cancer or finding cancer at a later stage when it’s harder to treat. We’re hoping that with FDA approved at-home tests, screening can be easier and more accessible.”

To schedule an appointment with a gynecologist at Jackson Health System, or for more information on your screening options at Jackson, click here.