FDA Approves HPV Self-Collection Solution for Cervical Cancer Detection

With this approval, individuals may collect their own vaginal sample, which clinicians can then analyze in a laboratory using a cobas® molecular instrument.

The FDA has approved a human papillomavirus (HPV) self-collection solution to help identify individuals who may be at risk of developing cervical cancer, according to a press release from the developers, Roche.¹

The self-collection solution is intended to provide a more accessible screening option for this population. With this approval, individuals may collect their own vaginal sample, which clinicians can then analyze in a laboratory using a cobas^® molecular instrument. Patients would then proceed to receive standard care following a positive HPV result.

“With vaccinations, innovative diagnostic tools and screening programs, achieving the World Health Organization [WHO]’s goal of eliminating cervical cancer by 2030 is within reach,” Matt Sause, chief executive officer at Roche Diagnostics, said in the press release.¹ “Our HPV self-collection solution helps support this goal by reducing barriers and providing access to HPV screening by allowing people to privately collect their own sample for HPV testing.”

Developers formed a partnership with the National Cancer Institute (NCI) to partly advance the regulatory pathway for the HPV self-collection solution. This partnership, the NCI Cervical Cancer ‘Last Mile’ Initiative, aimed to facilitate collaboration among federal and private sector groups to validate the clinical efficacy and accuracy of self-collected HPV testing for cervical cancer.²

According to the NCI, more than half of all cases of cervical cancer in the United States appear in individuals who receive infrequent screening or those who have never undergone screening. Socioeconomic disparities, geographic inaccessibility, and cultural factors are some of the obstacles that may contribute to these screening disparities. The use of self-collected samples for HPV testing is believed to address these disparities by extending screening access to the “last mile”, including individuals who receive no or infrequent screening.

One of the objectives of the NCI Last Mile initiative involved facilitating a trial in the United States assessing HPV self-collection among individuals who are at risk for cervical cancer. The Self-collection for HPV testing to Improve Cervical Cancer Prevention (SHIP) trial aims to provide an independent platform for investigating how usable, acceptable, and accurate various self-collection devices are in the detection of HPV associated with cervical cancer. Investigators aim to assess the use of clinic- and population-based strategies for expanding HPV self-collection, especially among groups with a high burden who do not receive adequate screening for cervical cancer. The NCI announced the launch of the SHIP trial in January 2024.³

“The SHIP Trial will generate independent clinical evidence on accuracy, usability, acceptability, and effectiveness to inform the FDA’s reviews for extending current regulatory approvals to include self-collection as an alternative sample collection approach,” trial co-leader Vikrant Sahasrabuddhe, MBBS, MPH, DrPH, the deputy chief of the Breast and Gynecologic Cancer Research Group and program director in the Division of Cancer Prevention at the NCI, said in a press release at the time of the trial’s launch.³

Investigators designed the SHIP trial to include a multi-center infrastructure spanning more than 25 clinical enrollment sites across the United States. Additionally, the NCI looks to collaborate with professional societies to update practice guidelines so that HPV self-collection approaches can be employed in clinical practice following regulatory approvals.

“The SHIP Trial clinical enrollment sites cover a wide spectrum of health system settings and have the potential to enroll [individuals who are] geographically, socioeconomically, racially, and ethnically diverse. Demonstrating that underserved populations are willing to participate in self-collection-based cervical cancer screening could help us reach those populations with the greatest need,” trial co-leader Philip E. Castle, PhD, MPH, director of the Division of Cancer Prevention (DCP) at the NCI, added.³

References

1. Roche announces FDA approval of one of the first HPV self-collection solutions in the U.S., expanding access and screening options to help eliminate cervical cancer. News release. Roche. May 15, 2024. Accessed May 15, 2024. https://tinyurl.com/4x8akas6
2. NCI Cervical Cancer ‘Last Mile’ Initiative. National Cancer Institute Division of Cancer Prevention. Accessed May 15, 2024. https://tinyurl.com/yfh964fh
3. NCI launches network to study self-collection for HPV testing to prevent cervical cancer. News release. National Cancer Institute Division of Cancer Prevention. January 25, 2024. Accessed May 15, 2024. https://tinyurl.com/kws5etxa