Marlborough, Mass. — Hologic, Inc. said its Aptima® HPV Assay has received an expanded CE-IVDR marking in the European Union and the United Kingdom to include self-collected vaginal samples.
The expanded indication allows samples to be collected in a healthcare setting using the Aptima Multitest Specimen Collection Kit. Hologic said the option could help increase participation among women who do not currently take part in routine cervical cancer screening.
Cervical cancer is the fourth most common cancer among women worldwide but is largely preventable through human papillomavirus vaccination and regular screening. Hologic said participation in established cervical cancer screening programs varies widely across Europe, with rates ranging from 25% to 80%.
“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.”
Hologic noted that patients who receive a positive result from a self-collected vaginal sample may require further evaluation using a cervical sample collected by a healthcare professional. Additional testing may be needed to determine appropriate clinical management or treatment.
The company said the effectiveness of cervical cancer screening also depends on ensuring that patients with positive results receive timely follow-up care.
Hologic develops diagnostic technologies for women’s health, including the ThinPrep® Pap test, ThinPrep Imaging System, Aptima HPV Assay and Genius™ Digital Diagnostics System.
The Aptima HPV Assay was CE marked under the European Union’s In Vitro Diagnostic Regulation, which is also recognized in several other countries.
