FDA-Approved Self-Test for HPV: Another Tool in Fight to Eliminate Cervical Cancer


Roche's self-collection kit allows women to screen for cervical cancer at home, offering an alternative to a visit to a health care provider and promoting early detection of the disease.

Earlier this month, the FDA approved a self-collection solution for human papillomavirus (HPV) from Roche Diagnostics, offering an accessible and discreet way for women to self-collect their own vaginal sample and screen against cervical cancer.1

Woman holding teal cervical cancer awareness ribbon / New Africa - stock.adobe.com

Woman holding teal cervical cancer awareness ribbon / New Africa - stock.adobe.com

The self-collection solution is one of the first available in the US and joins existing HPV vaccinations and diagnostic tools to eliminate cervical cancer in the US. Each year, more than 13,000 patients across the country are diagnosed with the disease caused by HPV infection.1

Key Takeaways

  • The FDA approved a new self-collection solution from Roche for HPV testing. This allows women to collect their own vaginal samples at home for cervical cancer screening, potentially increasing accessibility and privacy.
  • Early detection of cervical cancer through regular screening is crucial, and the self-collection option aims to address screening gaps.
  • Collaborations between Roche and the "Last Mile" initiative will provide valuable data on the effectiveness of self-collection and potentially lead to wider adoption of this method.

“With vaccinations, innovative diagnostic tools and screening programs, achieving the WHO’s goal of eliminating cervical cancer by 2030 is within reach,” said Matt Sause, CEO of Roche Diagnostics, in a news 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.”

Roche’s new self-collection kit is compatible and approved for use with its existing cobas HPV test. The cobas test, used for primary screening and co-testing, screens for the 14 high-risk HPV genotypes that lead to cervical cancer.

Samples from the self-collection solution are sent to a laboratory for analysis with the cobas molecular instrument. According to the company, the cobas test operates on the cobas 4800 and the fully automated cobas 5800/6800/8800 Systems, providing up to 144 results in about 8 hours for the cobas 5800 System, and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an 8-hour shift.1

The IMPACT trial evaluated the effectiveness of Roche’s cervical cancer portfolio among a diverse group of women, including those with a higher risk of HPV, undergoing routine cervical screenings. This large study provided valuable benchmarks to health care policies, laboratories, and clinicians on HPV prevalence, cytologic abnormalities, and cervical intraepithelial neoplasia in the US.2

READ MORE: Telehealth-Based OUD Treatment May Lead to Better Health, Obstetric Outcomes Among Pregnant Patients

Roche partnered with the National Cancer Institute (NCI) on the Cervical Cancer “Last Mile” initiative, a collaboration that, in part, facilitated the regulatory pathway towards FDA approval of the company’s self-collection kit.3

Although cervical cancer is highly preventable by HPV vaccination and by early detection and treatment of cervical precancerous changes, more than half of all patients diagnosed with cervical cancer in the US have never been screened or have only been screened infrequently.1 The “Last Mile” initiative addresses this screening gap, often exacerbated by access issues, social and economic barriers, history of traumatic experiences, cultural concerns, and embarrassment, to ensure everyone who needs cervical cancer screening can receive it.

By providing women with an alternative method to visiting a health care provider for cervical cancer screening, Roche supports the “Last Mile” mission to promote early detection of the disease.

Building on its partnership with the “Last Mile” initiative, Roche is actively involved in the “Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial,” announced earlier this year at the White House Cervical Cancer Forum.3 The company will contribute self-collection kits and assays to the trial, aimed at evaluating the effectiveness of self-collection to inform wider implementation. Samples will undergo blinded testing, with unblinded data analysis conducted by the NCI and reported simultaneously to the FDA. The trial is expected to open in 2024.

READ MORE: Women's Health Resource Center

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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 Diagnostics. May 15, 2024. Accessed May 30, 2024. https://diagnostics.roche.com/us/en/news-listing/2024/roche-announces-fda-approval-of-one-of-the-first-hpv-self-collection-solution-in-the-us-expanding-access-screening-options-to-help-eliminate-cervical-cancer.html
2. 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
3. NCI Cervical Cancer ‘Last Mile’ Initiative. Article. National Cancer Institute. Accessed May 30, 2024. https://prevention.cancer.gov/major-programs/nci-cervical-cancer-last-mile-initiative
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