HPV Assay Gains Expanded CE Mark for Self-Collected Vaginal Samples

However, even where organized screening programs exist, participation varies widely across Europe, with some regions showing stagnation or decline. A new regulatory indication now enables human papillomavirus (HPV) screening using self-collected vaginal samples in the European Union and the UK, potentially expanding access within established care pathways.

Hologic’s Aptima HPV Assay has received an expanded CE marking under the In Vitro Diagnostic Regulation (IVDR) in the European Union and the UK, adding an indication for self-collected vaginal samples obtained with the Aptima Multitest Specimen Collection Kit. The new claim offers an alternative method of cervical cancer screening for individuals who are not currently participating in clinician-collected sampling. The update is positioned to support programmatic screening efforts by aligning self-collection with an assay already used in laboratory workflows.

Under the new indication, sampling may be performed by patients in a healthcare setting, with laboratory testing carried out on the self-collected vaginal specimen. For those with positive results, further evaluation may require a clinician-collected cervical sample to inform appropriate management, including any additional testing or treatment. Timely connection to follow-up care remains essential to realize the impact of screening on outcomes.

The Aptima HPV Assay is CE marked in accordance with IVDR requirements, which is also recognized by other countries around the world. Hologic notes that commercialization of the self-collection indication will be announced on a country-by-country basis. The indication is not currently available in the United States.

“Despite the benefits of cervical cancer screening, there are still barriers to participation. Some women do not participate for psychosocial, cultural, economic or access reasons. Expanding our CE mark for the Aptima HPV Assay to include self-collection in a healthcare setting offers women an alternative method of screening and has the potential to improve screening participation rates,” said Andrew Pieprzyk, Vice President, Strategic Development, Diagnostics, International at Hologic.