Hologic’s Aptima HPV Test Wins CE Mark for Self-Collected Samples

Hologic announced that it’s gained expanded CE-IVDR marking in the EU and UK for its Aptima HPV test, which approves self-collected vaginal samples using the Aptima Multitest Specimen Collection Kit.

Evidence shows that organized screening and early detection reduces deaths from cervical cancer, with mortality reduction rates in Europe varying from 41% to 92%. Unfortunately, even in countries that an established cervical screening program, participation rates range from 25% to 80%.

Self-sampling could increase HPV screening rates in under-screened populations, but clear follow-up steps are necessary for patients who receive positive results. Further evaluation after a positive result might need a clinician-collected cervical sample to guide appropriate clinical management.

The approval reinforces Hologic’s dedication to improving women’s health. The company strives to innovate in the cytology space: from the introduction of the ThinPrep Pap test and launch of the ThinPrep imaging system, to the Aptima HPV assay, to the Genius digital diagnostics system.

“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, VP of 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.”