Hologic has received approval from the US Food and Drug Administration for its Aptima HPV Assay to be used as a primary screening option for cervical cancer using clinician-collected samples.
The approval expands the role of the assay beyond its existing use in co-testing and reflex testing, allowing it to be used as a stand-alone primary screening test.
The Aptima HPV Assay detects messenger RNA (mRNA) from high-risk types of human papillomavirus (HPV), which are responsible for the majority of cervical cancer cases. It is currently the only FDA-approved HPV test that uses mRNA technology for primary cervical cancer screening, a method designed to identify infections more likely to progress to clinically significant disease.
The regulatory decision was supported by data from a large real-world evaluation comparing the Aptima assay with other FDA-approved HPV DNA tests. The analysis demonstrated that the assay effectively identified cervical intraepithelial neoplasia grades 2 and 3, which are considered clinically relevant precancerous lesions, while reducing the likelihood of detecting transient infections that may resolve without intervention.
Primary HPV screening is increasingly recognised in clinical guidelines as an effective approach for early detection of cervical cancer risk. The approval enables healthcare providers to adopt HPV-first screening strategies using the Aptima assay, offering additional flexibility in cervical cancer prevention and screening programmes.
With this approval, Hologic strengthens its women’s health diagnostics portfolio and expands available screening options aimed at improving early detection and reducing the burden of cervical cancer.
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