There has been significant advancements in cervical cancer screening through the use of self-collection test for Human papillomavirus (HPV). HPV screening plays a critical role in the prevention and early detection of cervical cancer. Cervical cancer is  a leading cause of cancer-related deaths among women worldwide. HPV is the most-prevalent cause of cervical cancer. Early detection through screening significantly improves treatment outcomes and reduces mortality. Current cervical cancer screening practices typically involve cytology-based Pap smears, HPV DNA testing, or a combination of both. While these methods have been effective in reducing cervical cancer incidence, they face limitations. Challenges include variability in sensitivity, the need for repeated testing, and limited accessibility in low-resource settings. This article reviews recent advancements in HPV screening technologies aimed at overcoming these challenges and improving global cervical cancer prevention efforts.

FDA Approval of Self-Collection Method

On May 14, 2024, the Food and Drug Administration (FDA) expanded the approvals of two HPV tests, allowing patients to collect their own vaginal samples for HPV testing in a health care setting. The approved tests are the Onclarity HPV test by Becton, Dickinson and Company (BD) and the cobas HPV test by Roche Molecular Systems.

The self-collection method involves using a swab or brush to obtain a vaginal sample, which must be performed in a health care setting such as primary care offices, urgent care centers, pharmacies, or mobile clinics. This innovative approach aims to increase access to cervical cancer screening, particularly for individuals who cannot or prefer not to undergo a pelvic exam.

‘Last Mile’ Initiative

The approvals are part of the NCI’s ‘Last Mile’ Initiative. This initiative is a public-private partnership focused on accelerating the development and approval of self-collection methods for HPV testing. The initiative also includes the Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) trial.

SHIP Trial – is HPV Self-Collection at home effective?

The SHIP Trial was launched in early 2024 as a nationwide clinical trial. It is designed to evaluate the usability, acceptability, and accuracy of various self-collection device-assay combinations. It will determine whether self-collection in a home environment is as effective as collection performed by a clinician in a health care setting. The trial encompasses 25 clinical sites across the U.S. and aims to recruit a diverse group of participants. Data collected from this trial will play a crucial role in informing the FDA’s reviews. It is hoped that current regulatory approvals will extend to include self-collection as a viable sample collection option.

Impact on Cervical Cancer Screening

The expanded approvals and the ongoing SHIP Trial are projected to enhance access to cervical cancer screening, especially for underserved and underscreened populations. Self-collection methods have already shown success in other countries and are seen as a promising solution to mitigate health disparities in cervical cancer screening in the U.S.

While the current approvals mark a significant milestone, they represent only the beginning of progress. Future approvals are anticipated as more evidence is gathered through the ‘Last Mile’ Initiative and the SHIP Trial. This will potentially pave the way for home-based self-collection. The push for self-collection methods is expected to transform cervical cancer screening. It will make screaming more accessible for all individuals, regardless of their circumstances. Keep up to date and learn more about this progress from the reviewed NHI report.