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FDA approves HPV self-collection for cervical cancer screening

ACS applauds decision, which will expand access.

The US Food and Drug Administration on May 15 approved primary human papillomavirus (HPV) self-collection for cervical cancer screening in a health care setting. The American Cancer Society applauds this decision, 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. There are many advantages of self-collection compared to provider-collected screening samples. This news covers self-collection in the presence of a provider, not at-home collection. A subsequent approval phase may include at-home self-collection. 

ACS experts anticipate self-collection at 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.

Cervical cancer is one of the few cancers that can prevented through regular screening.

“Despite the benefits of cervical cancer screening, not all women and people with a cervix get screened regularly,” ACS Chief Scientific Officer Dr. Bill Dahut said in a news release. “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 as a screening method for this potentially deadly disease can make a huge impact.”

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