Hologic Announces Its Aptima HPV Assay Gets FDA Approval For Clinician-Collected HPV Primary Screening

Hologic, Inc. (Nasdaq: HOLX) announced today that its Aptima® HPV Assay received FDA approval for clinician-collected HPV primary screening. Hologic's human papillomavirus (HPV) test is the only FDA-approved mRNA-based assay, designed specifically to detect infections most likely to lead to cervical cancer.

Screening for cervical cancer is critically important to women's health. In the United States, it is estimated that in 2026, approximately 13,490 new cases of invasive cervical cancer will be diagnosed, and about 4,200 women will die from the disease.1 However, many of these deaths are preventable with regular screening and appropriate follow-up on abnormal results. Timely follow-up is essential for early detection and treatment to reduce cervical cancer cases and deaths.