The US Food and Drug Administration approved an expanded indication for the Aptima human papillomavirus assay for clinician-collected primary human papillomavirus screening, according to a press release from Hologic Inc. The clearance adds a primary screening option to the company’s existing Pap testing and Pap plus human papillomavirus co-testing modalities.

In the US, an estimated 13,490 new cases of invasive cervical cancer are expected to be diagnosed in 2026, with approximately 4,200 deaths. Many of these deaths are considered preventable through regular screening and appropriate follow-up of abnormal results.

The newly approved indication applies to the Aptima HPV assay, which uses messenger RNA detection to identify infections most likely to lead to cervical cancer. According to the company, the assay is the only US Food and Drug Administration–approved HPV test that targets messenger RNA rather than viral DNA. With this approval, Hologic now offers all three major US Food and Drug Administration–approved and guideline-recommended cervical cancer screening strategies: Pap testing alone, Pap plus HPV co-testing, and primary HPV testing.

Regulatory clearance followed completion of a large real-world evidence study involving more than 650,000 women across multiple US health systems representing diverse patient populations and clinical settings. In the study, researchers compared the Aptima HPV assay with an approved DNA-based HPV test when used for primary screening. The company reported that the sensitivity of the Aptima HPV Assay was clinically comparable to the comparator test. The assay was effective for detection of cervical intraepithelial neoplasia grade two or higher and grade three or higher.

Pap plus HPV co-testing remains the most comprehensive screening modality. Hologic stated that its range of testing options gives providers flexibility in selecting a screening approach based on patient age, access, and risk factors. More than 90% of providers report strong confidence in co-testing for patients aged 30 to 65 years, and published data have shown that co-testing detects up to 95% of cervical cancers.

Source: Hologic Inc