The U.S. Food and Drug Administration expanded clearance for Hologic’s Aptima HPV assay, authorizing clinician-collected HPV primary screening in addition to existing Pap and co-testing indications. Hologic framed the decision as an extension of its long-standing cervical cancer screening portfolio and said the broader indication offers clinicians more flexibility in choosing guideline-recommended screening strategies. The company noted that co-testing remains the most comprehensive modality but that expanded options could improve access and tailor screening by age and risk. Hologic also highlighted its digital diagnostics and AI imaging tools as complementary innovations in cervical cancer detection.
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