The U.S. Preventive Services Task Force (USPSTF) has pitched an update to its national guidelines for cervical cancer screening—including self-collection tests for HPV among its recommendations for the first time.
The change comes after the FDA earlier this year approved two diagnostic kits that enable patients to collect vaginal swab samples themselves, allowing them to skip a pelvic exam by a clinician.
Currently, the USPSTF urges that women between the ages of 21 and 65 get screened for the highly preventable cancer at least every three years. For those between 21 and 29, that means a Pap smear cervical cytology exam.
For women between 30 and 65, the guidelines—last updated in 2018—include either cervical cytology every three years or high-risk human papillomavirus (HPV) testing every five years, or a combination of the two.
The task force’s new draft recommendation largely follows the same cycle but places additional emphasis on HPV testing, as the virus is known to be linked to 95% of all cervical cancers.
And, as before, the group continues to recommend against screening women younger than 21 and older than 65 as well as those who have had a hysterectomy.
“The latest science shows that screening for cervical cancer with an HPV test is the optimal approach for women who are 30 to 65 years old,” John Wong, M.D., vice chair of the task force and a professor of medicine at Tufts University, said in a statement. “These women also have the option of getting screened with a Pap test or co-testing. That said, Pap tests continue to be the best option for women in their 20s.”
When it comes to self-collection, the USPSTF said studies have shown it is just as accurate as clinician-led samples and that offering the option can help improve testing rates.
“Women who would be more comfortable collecting their HPV test sample themselves can now do so,” said task force member Esa Davis, M.D., associate vice president for community health at the University of Maryland, Baltimore. “We hope that this new, effective option helps even more women get screened regularly.”
In May, the FDA granted green lights to separate collection kits from BD and Roche. The tests were not approved for solo, at-home use; they still need to be administered in a healthcare setting. However, the companies have said that it’s a step toward broadening their use in potentially retail pharmacies, mobile clinics or other areas that may lack providers trained in collecting a sample via a speculum.
“BD is fully supportive of the new guidance as we have seen the benefits of self-collection firsthand in countries outside the U.S. that have had this option for some time and the increased rates of HPV screening that result from increased access,” a company spokesperson told Fierce Medtech, following the USPSTF’s draft publication.
Last month, BD announced that it would work with MD Anderson Cancer Center and the healthcare provider Su Clinica to study HPV test self-collection among underserved communities in southern Texas.
That program will provide bilingual self-collection options and financial support for uninsured patients, and its findings will help develop methods to scale up the test to other areas nationwide. BD previously obtained a European approval for at-home HPV testing during the COVID-19 pandemic.
Meanwhile, Hologic touted the success of screening programs overall, including Pap smears. Cervical cancer was once a leading cause of cancer death among women, and mortality rates have dropped 70% in recent decades—however, incidence rates are now rising, with cases disproportionately impacting Black and Hispanic women.
“Today’s recommendations are an important acknowledgement of the role of Pap testing combined with HPV testing, which is the gold standard of care and the most effective method of identifying cervical cancer,” Jennifer Schneiders, Ph.D., Hologic’s diagnostics president, said in a statement. “Eliminating cervical cancer is within our reach and history has shown us that safeguarding the most comprehensive screening available is critical to that effort.”