FDA Greenlights HPV Self-Collection Solution for Cervical Cancer Screening

• One of the first human papillomavirus (HPV) self-collection solutions for use in the US has been approved by the FDA.
• This HPV self-collection solution can be used to identify women who are at risk of developing cervical cancer.
• This accessible screening option allows women to have the option to privately collect their own vaginal sample.

The FDA has granted approval to the use of self-collected samples for HPV testing when cervical samples cannot be obtained, according to Roche.¹

HPV self-collection solution is an accessible screening option for women, offering an alternative option compared with the healthcare setting as it allows for the private collection of one's own samples. This can be used to aid in the identification of women who are at risk of developing cervical cancer.

Individuals gather their own samples with HPV self-collection. These are then sent to a laboratory for analysis with Roche’s cobas® molecular HPV test. Those with a positive HPV result may then continue to receive care under a health care provider.

“With vaccinations, innovative diagnostic tools, and screening programs, achieving the World Health Organization’s goal of eliminating cervical cancer by 2030 is within reach,” said Matt Sause, chief executive officer of Roche Diagnostics, in a press release. “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.”

3D rendering of gynecologic cancer: © tom - stock.adobe.com

Self-collection can improve access to cervical cancer screening, especially in underserved populations. In the US, Black, Hispanic, and American Indian women tend to have higher rates of cervical cancer compared with women of other racial groups. The highest rate of death is seen among Black women.² With this new self-collection solution for cervical cancer screening, women have another option to identify a high-risk HPV infection in more convenient care settings.²

According to the press release, Roche worked with the National Cancer Institute to participate in the Cervical Cancer “Last Mile” Initiative, which looked to address disparities in cervical cancer screening. This has helped pave the regulatory pathway toward this approval.^1,2

Notably, the HPV self-collection solution is approved for use with Roche's cobas® HPV test, which is used for primary screening as well as co-testing.1 While a Pap smear can identify cervical abnormalities, the cobas® HPV test is able to detect 14 types of high-risk HPV genotypes that increase the risk of developing cervical cancer. The cobas® HPV test runs on both the cobas® 4800 and the fully automated cobas® 5800/6800/8800 Systems. These offer speedy results, including up to 96 results in approximately 3 hours with cobas® 4800 system, 384 results within an 8-hour shift with the cobas® 6800 system, and 1056 results within 8 hours with the coba®s 8800 system.

The IMPACT trial was utilized to validate the clinical benefits of this solution. In the study, 35,263 patients were included, and representation was diverse: 21% of the patients were Black, 24% were Hispanic-Latino, and 0.3% were American Indian or Alaskan Native. The press release stated that “this diversity was critical to accurately assess the performance of dual stain in patient populations with higher incident rates of HPV.”

Patients between aged 25 to 65 years were included in the trial who were undergoing routine screening for HPV.3 In these patients, liquid-based cytology and 2 polymerase chain reaction-based tests for high-risk human papillomavirus were performed.³

Findings showed that with the cobas® 6800/8800 Systems, high-risk HPV, HPV 16, and HPV 18 were detected in 15.1%, 3.1%, and 1.4% of patients, respectively. Cytologic abnormalities and HPV positivity declined as age increased, and of the patients who had a biopsy and a colposcopy, the rate of cervical intraepithelial neoplasia of grade 2 or higher was 8.8% while the rate of those grade 3 or higher was 3.6%.

The baseline cumulative risk for cervical intraepithelial neoplasia of grade 3 or higher was 13.6% (95% CI, 11.5%-15.7%) for the patients who tested positive for HPV 16, and at 1-year, this rate was 16.9% (95% CI, 14.4%-19.8%). Additionally, patients who were HPV-negative had a cumulative risk for cervical intraepithelial neoplasia of grade 3 or higher rate of 0.06% (95% CI, 0.02%-0.10%).

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/mtskaest

2. Women in U.S. can now collect their own sample for cervical cancer screening. News release. BD. May 15, 2024. Accessed May 15, 2024. https://tinyurl.com/mub9uav9

3. Safaeian M, Wright TC Jr, Stoler MH, et al. The IMproving primary screening and colposcopy triage trial: human papillomavirus, cervical cytology, and histopathologic results from the baseline and 1-year follow-up phase. Am J Obstet Gynecol. 2021;225(3):278.e1-278.e16. doi:10.1016/j.ajog.2021.03.047