Hologic’s Aptima check secures FDA clearance for major HPV screening
Hologic has acquired approval from the U.S. Meals and Drug Administration (FDA) for its Aptima HPV assay to be used in physician-collected major screening, additional increasing its cervical healthcare portfolio.
The human papillomavirus (HPV) check is claimed to be presently the one FDA-approved messenger RNA (mRNA)-based check designed to determine infections with the very best danger of resulting in cervical most cancers.
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With this FDA approval, Hologic now provides three main guideline-recommended strategies: Pap testing, major HPV testing and Pap + HPV co-testing.
This newest indication follows the approval of the Genius Digital Diagnostics System with the Genius Cervical AI Algorithm, which makes use of digital imaging and AI to help the detection of cytological abnormalities and precancerous lesions.
The approval was granted following the completion of a real-world HPV screening research involving greater than 650,000 ladies from varied US well being care programs.
The research in contrast the Aptima HPV assay to an FDA-cleared deoxyribonucleic acid (DNA)-based check and located that medical sensitivity for detecting cervical intraepithelial neoplasia grade two or larger (CIN2+) and cervical intraepithelial neoplasia grade three or larger (CIN3+) was related.
Jennifer Schneiders, president of Hologic Diagnostic Options, mentioned, “Hologic has been on the forefront of cervical most cancers screening for many years, and the extra indication of the Aptima HPV assay displays our continued dedication to advancing ladies’s well being by means of revolutionary, evidence-based options.
“Our dedication to offering complete healthcare options that meet the wants of healthcare suppliers and sufferers is unwavering, and by providing healthcare suppliers extra selection and suppleness, we can assist them ship essentially the most personalised care for each affected person.”
In October 2025, Hologic introduced its acquisition by different asset administration entities Blackstone and TPG for an enterprise worth of as much as $18.3 billion, based on a definitive settlement.
