FDA Approves New Self-Collection Option for HPV Testing

The FDA approved a new self-collection test to detect human papillomavirus (HPV) and identify women at risk for cervical cancer, maker Roche announced on Wednesday.

“HPV self-collection offers an accessible screening option” and “will improve access to testing by providing women the option to privately collect their own sample,” Roche said in a press release. The company added that this could help reduce a barrier to screening and contribute to the WHO’s goal of eliminating cervical cancer by 2030.

The test is to be used in healthcare settings, where the patient collects their own vaginal sample without the need for an invasive pelvic exam. The sample is then sent to the laboratory to be analyzed with the company’s cobas HPV testing system, which is used for primary screening and co-testing and can detect cervical intraepithelial neoplasia of grade 2/3 or worse. Roche’s cobas HPV testing system was validated in the IMPACT trial, but did not involve self-collection of samples.

According to the National Cancer Institute, more than 13,000 women are newly diagnosed and 4,000 women die every year in the U.S. from cervical cancer. Over half of cervical cancer cases in the U.S. occur among women who have been never screened, infrequently screened, or who never participate in routine screening.

Many factors can contribute to individuals not participating in cervical cancer screening programs, such as access to healthcare, social and economic barriers, cultural concerns, among others. The National Cancer Institute’s Cervical Cancer “Last Mile” Initiative has focused on self-collection of cervical samples that can be done at home and sent for HPV testing. The intervention is designed to address disparities and expand cervical cancer screening access to reach the “last mile,” which represents individuals who are never screened or underscreened.

Although Roche’s HPV self-collection test is designed to be used in a clinical setting, results from home collection HPV test kits have been mixed. In the HOME trial, mailing at-home HPV test kits to underscreened women failed to significantly increase the detection or treatment of cervical precancers compared with usual care. However, the more recent STEP trial found that mailing patients an HPV self-sampling kit increased cervical cancer screening for those due or overdue for screening.

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