Hologic Expands Aptima HPV Test CE-IVDR Mark for Self-Collected Samples in EU and UK
Event summary
- Hologic’s Aptima® HPV Assay received an expanded CE-IVDR mark in the EU and UK, now approved for self-collected vaginal samples using the Aptima Multitest Specimen Collection Kit.
- The expansion aims to improve cervical cancer screening participation rates by offering an alternative method for women who face barriers to traditional screening methods.
- Commercialization will be announced on a country-by-country basis and is not currently available in the United States.
The big picture
Hologic’s expansion of the Aptima® HPV Assay CE-IVDR mark aligns with broader industry trends toward patient-centric healthcare solutions. By enabling self-collected samples, Hologic aims to address low participation rates in cervical cancer screening programs, which vary widely across Europe. This strategic move could enhance market penetration and reinforce Hologic’s leadership position in women’s health diagnostics.
What we're watching
- Adoption Rates
- How quickly healthcare providers and patients in the EU and UK will adopt self-collected sample screening methods.
- Regulatory Impact
- Whether the expanded CE-IVDR mark will facilitate similar approvals in other regions, particularly the United States.
- Market Competition
- The pace at which competitors may introduce similar self-collection capabilities for HPV screening tests.
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