US approves at-home HPV testing

The US has approved guidance allowing at-home HPV testing for women aged 30 to 65 at average risk for the first time.

The Department of Health and Human Services announced updated cervical cancer screening guidance on Monday, permitting women aged 30 to 65 at average risk to collect a vaginal swab at home and mail it to a laboratory for processing.

Human papillomavirus is the most common sexually transmitted infection in the US and is responsible for most cervical cancers. The disease kills more than 4,000 women in the US each year.

Tom Engels, administrator of the Health Resources and Services Administration, said: “These updates represent a significant step forward in cervical cancer screening and will improve screening rates and save lives.

“By expanding screening options and removing cost barriers, we’re helping more women take an active role in protecting their health and their future.”

The guidance recommends women aged 30 to 65 screen for the virus every five years, either at home or with a clinician.

Women aged 21 to 29 are still advised to have a Pap smear, which checks for abnormal cervical cells, every three years. Traditional Pap tests carried out by doctors will remain available.

New provisions also require most insurance plans to cover any additional testing needed to complete the screening process, with coverage beginning from 1 January 2027.

At-home tests are not yet available to consumers. However, the Food and Drug Administration approved two self-swab tests from Becton, Dickinson and Company and Roche Holding AG for use in clinical settings earlier in the week.

Last year, the agency approved the first at-home screening tool to detect cervical cancer.

The guidance follows updated recommendations from the American Cancer Society released in December, which endorsed at-home testing every three years for women aged 25 to 65.

Dr Robert Smith, the society’s chief screening expert, said: “Cervical cancer is a highly preventable disease. Yet, despite all the progress we’ve made in the US reducing the incidence and mortality from cervical cancer mainly through screening, recent reports indicate that up-to-date cervical cancer screening rates have declined since 2021 and, notably, have not rebounded in the post pandemic period.”

About 13,000 new cases are diagnosed in the US each year and around one in four American women are not up to date on their screening.

Rates have been rising among women in their 30s and 40s, many of whom were not eligible for HPV vaccines when they were first released in 2006.