Press Releases

American Cancer Society Statement: FDA Approval of HPV Self-Collection for Cervical Cancer Screening
May 15, 2024

Today the Food and Drug Administration (FDA) approved primary human papillomavirus (HPV) self-collection for cervical cancer screening in a health-care setting. The American Cancer Society (ACS) applauds the FDA efforts as it will expand access to cervical cancer screening, providing a more convenient and private option for all women and people with a cervix. Self-collection is when a patient uses a collection kit to take a vaginal sample that will be tested for HPV, the virus that causes almost all cases of cervical cancer. 

“Almost all cervical cancers are caused by persistent infection with certain types of HPV,” said Dr. Karen E. Knudsen, CEO of the American Cancer Society. “Self-collection can expand access to screening and reduces barriers, which will give more people the opportunity to detect, treat, and ultimately survive cancer.”

“Despite the benefits of cervical cancer screening, not all women and people with a cervix get screened regularly,” said Dr. William Dahut, chief scientific officer at the American Cancer Society. “Most cervical cancers are found in people who have never had a cervical cancer screening test or who have not had one recently. That’s why adding self-collection in a health-care center as a screening method for this potentially deadly disease can make a huge impact.”

ACS cervical cancer screening guidelines 

ACS recommends cervical cancer screening begin at age 25 for women and people with a cervix. Those aged 25 to 65 should have a primary HPV test every 5 years. (A primary HPV test means the HPV test is done without cytology; follow-up screening can be done with a Papanicolaou (Pap) test if needed.) If primary HPV testing is not available, screening may be done with either a co-test every 5 years, which combines an HPV test with a Papanicolaou (Pap) test, or a Pap test alone every 3 years. ACS guidelines recommend primary HPV testing as the preferred method for cervical cancer screening, but self-collection, a form of primary HPV testing, has been studied for over two decades and is feasible, acceptable, and comparable to clinician-collected samples.

“We anticipate self-collection in a health-care setting will play an increasingly prominent role in cervical cancer screening once regulatory and clinical prerequisites are in place and as supporting evidence continues to accumulate,” Dahut added.

More information on ACS guidelines on cervical cancer screening can be found here.

For further information: FOR MORE INFORMATION, CONTACT: American Cancer Society,