Hologic Expands CE-IVDR Approval for Aptima HPV Assay to Support Self-Collected Cervical Cancer Screening Samples
Hologic, Inc. has announced that its Aptima® HPV Assay has received an expanded CE-IVDR marking in the European Union and the United Kingdom, allowing the test to be used with self-collected vaginal samples obtained using the Aptima Multitest Specimen Collection Kit. The expanded approval represents an important step in broadening access to cervical cancer screening by providing women with an alternative sample collection option within healthcare settings. The new indication is expected to help address barriers that have limited participation in screening programs while supporting public health efforts to detect cervical cancer earlier and reduce disease-related mortality.
The expanded certification reflects Hologic’s continued commitment to advancing women’s health through innovative diagnostic technologies that improve access, accuracy, and patient-centered care. By enabling self-collected samples, the company aims to support healthcare providers and screening programs in reaching women who might otherwise delay or avoid routine cervical cancer screening.
Addressing a Preventable Global Health Challenge
Cervical cancer remains one of the most significant health threats affecting women worldwide. It is currently recognized as the fourth most common cancer among women, despite being one of the most preventable forms of cancer when appropriate vaccination and regular screening programs are available.
Persistent infection with high-risk types of human papillomavirus (HPV) is the primary cause of cervical cancer. Early detection of these high-risk HPV infections enables healthcare professionals to identify women who may require additional monitoring or treatment before abnormal cervical cells develop into invasive cancer.
Extensive research has demonstrated that organized cervical screening programs significantly reduce both the incidence of cervical cancer and related deaths. Across Europe, countries with established screening initiatives have reported reductions in cervical cancer mortality ranging from approximately 41% to more than 90%, highlighting the life-saving impact of early detection.
However, despite these proven benefits, participation in cervical cancer screening programs remains inconsistent across Europe. Screening rates vary substantially between countries, with participation levels ranging from roughly one-quarter of eligible women to nearly four-fifths. In several regions, participation has also plateaued or declined over recent years, creating ongoing public health concerns.
Overcoming Barriers to Screening Participation
Healthcare experts recognize that numerous factors prevent many women from participating in routine cervical cancer screening. These barriers extend beyond medical concerns and often include psychological, cultural, financial, and logistical challenges.
Some women experience embarrassment or anxiety associated with clinician-collected cervical samples. Others face cultural or religious considerations that discourage participation. Limited access to healthcare facilities, transportation difficulties, scheduling conflicts, or financial constraints may further reduce screening attendance, particularly among underserved populations.
By introducing an approved self-collection option within healthcare environments, Hologic hopes to provide women with greater flexibility and comfort during the screening process.
Andrew Pieprzyk, Vice President of Strategic Development for Diagnostics, International at Hologic, emphasized that although cervical cancer screening has demonstrated substantial benefits, participation remains below desired levels because many women continue to encounter practical and personal obstacles.
According to Pieprzyk, expanding the CE-IVDR marking for the Aptima HPV Assay to include self-collected samples provides healthcare providers with another evidence-based screening option that may encourage more women to participate in routine HPV testing.
Self-Collection Offers New Opportunities
The newly approved indication allows women to provide their own vaginal sample using the Aptima Multitest Specimen Collection Kit while remaining within an appropriate healthcare setting.
Self-collection has emerged as an increasingly important strategy in cervical cancer prevention because studies have shown that it can improve participation among women who have historically been under-screened or never screened.
Many women report that self-sampling is more convenient, less invasive, and more comfortable than traditional clinician-collected cervical sampling. These advantages may encourage individuals who previously avoided screening to participate, ultimately increasing overall coverage within national screening programs.
Expanding access to self-collection also aligns with broader public health strategies focused on reducing healthcare inequalities and reaching vulnerable populations that often experience lower screening rates.
Importance of Follow-Up After Positive Results
Although self-collection provides greater accessibility, Hologic emphasizes that positive HPV test results must be followed by appropriate clinical evaluation.
Because self-collected specimens are vaginal samples rather than clinician-collected cervical samples, women receiving positive HPV results may require an additional cervical specimen collected by a healthcare professional. This follow-up enables clinicians to perform further diagnostic assessments and determine the most appropriate clinical management.
Additional investigations may include cytology testing, colposcopy, or other diagnostic procedures depending on local clinical guidelines and the patient’s overall risk profile.
Timely follow-up remains essential to achieving the full benefits of cervical cancer screening. Detecting HPV infection is only the first step in preventing disease progression. Appropriate clinical evaluation and treatment, when necessary, ensure that precancerous changes can be identified and managed before invasive cancer develops.
Healthcare providers therefore play a critical role in ensuring that women with positive screening results remain connected to appropriate diagnostic and treatment pathways.
Continuing Innovation in Women’s Health
The expanded CE-IVDR marking builds upon Hologic’s long-standing investment in cervical cancer prevention technologies.
Over the years, the company has introduced numerous innovations designed to improve laboratory efficiency, diagnostic accuracy, and patient outcomes. These include the ThinPrep® Pap Test, which transformed cytology-based cervical screening, followed by the ThinPrep Imaging System, which enhanced laboratory workflow through automated image review.
Hologic later expanded its molecular diagnostics portfolio with the Aptima HPV Assay, providing highly sensitive detection of high-risk HPV infections associated with cervical cancer development.
More recently, the company introduced the Genius™ Digital Diagnostics System, combining digital imaging with advanced technologies to support cytology laboratories in delivering efficient and accurate cervical cancer screening services.
Together, these innovations reflect Hologic’s strategy of integrating molecular diagnostics, digital pathology, and laboratory automation to improve women’s healthcare across the continuum of cervical cancer prevention.
CE-IVDR Certification Supports International Adoption
The Aptima HPV Assay has been CE marked under the European Union’s In Vitro Diagnostic Regulation (IVDR), one of the world’s most comprehensive regulatory frameworks governing diagnostic medical devices. Compliance with CE-IVDR requirements demonstrates that the assay meets rigorous standards for safety, clinical performance, and quality.
In addition to recognition across the European Union and the United Kingdom, CE-IVDR certification is acknowledged in several international markets, potentially supporting broader adoption of the technology in countries that recognize European regulatory standards.
Hologic noted that commercialization of the newly approved self-collection indication will occur on a country-by-country basis, depending on local market readiness and regulatory considerations.
The company also clarified that this expanded indication is not currently available in the United States, where regulatory approval for self-collected samples has not yet been granted.
Expanding Access to Life-Saving Screening
The expanded CE-IVDR approval for the Aptima HPV Assay represents another milestone in efforts to modernize cervical cancer screening and improve participation rates across Europe and other international markets. By incorporating self-collected vaginal samples into approved screening pathways, Hologic is providing healthcare systems with an additional tool to reach women who may otherwise remain unscreened.
As countries continue working toward the global goal of eliminating cervical cancer as a public health problem, innovations that increase accessibility while maintaining high diagnostic standards will play an increasingly important role. Hologic’s latest regulatory expansion underscores the company’s ongoing commitment to supporting laboratories, clinicians, and public health organizations in delivering effective cervical cancer prevention through earlier detection and broader screening access.
About Hologic
Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world.