CE-IVDR Mark for Hologic’s Aptima® HPV Test Expanded to Include Self-Collected Sample Claim in Cervical Cancer Screening

New indication in the European Union and the UK offers alternative method of screening especially for women who are not currently participating

Hologic, Inc. announced today that its Aptima^® HPV Assay received an expanded CE-IVDR marking in the European Union and the UK and is now approved for self-collected vaginal samples using the Aptima Multitest Specimen Collection Kit.

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Hologic’s Aptima® HPV Assay and Aptima Multitest Specimen Collection Kit

Cervical cancer is the fourth most common cancer in women but is largely preventable through HPV vaccination and regular screening.¹ Evidence shows that organized screening and early detection reduces deaths from cervical cancer, with mortality reduction rates in Europe ranging from 41% to 92%.² However, even in countries with an established cervical screening program, screening participation rates vary widely, from 25% to 80%, with some showing stagnation or decline in recent years.³

“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,” said Andrew Pieprzyk, Vice President, Strategic Development, Diagnostics, International at Hologic. “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.”

While self-sampling has the potential to increase HPV screening rates in under-screened populations, clear follow-up steps are essential for patients with positive results. Because self-collected samples are vaginal samples, further evaluation following a positive result may require a clinician-collected cervical sample to guide appropriate clinical management, including any additional testing or treatment.⁴ The impact of screening depends on timely connection to follow-up care for those who need it.

Hologic is dedicated to improving women’s health, particularly through cervical cancer screening and early detection. From the introduction of the ThinPrep^® Pap test to the launch of the ThinPrep Imaging System, Aptima HPV Assay and most recently the Genius^TM Digital Diagnostics System, Hologic continues to innovate in the cytology space to support laboratories, healthcare providers and patients alike.

Hologic’s Aptima HPV Assay was CE marked in the European Union in accordance with the In Vitro Diagnostic Regulation, which is also recognized by other countries around the world.

Commercialization will be announced on a country-by-country basis. This indication is currently not available in the United States.

To learn more about the Aptima HPV Assay, visit here.

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. For more information on Hologic, visit www.hologic.com and connect with us on LinkedIn, Facebook, X, Instagram and YouTube.

Forward-Looking Statements

This press release may contain forward-looking information that involves risks and uncertainties. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

Hologic, Aptima, ThinPrep and Genius are trademarks or registered trademarks of Hologic, Inc. in the United States and/or other countries.

CE 2797 Notified Body number wherever applicable.

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