FDA approves Hologic's HPV test for primary cervical cancer screening

Hologic has secured FDA approval for its Aptima HPV Assay as a primary screening tool for cervical cancer. The test, which detects high-risk HPV infections most likely to progress to the disease, now offers clinicians more flexibility in testing options. This expansion comes as part of the company's broader effort to improve early detection and prevention.

The Aptima HPV Assay is the only mRNA-based HPV test cleared by the FDA for primary screening. Unlike traditional co-testing (Pap + HPV), which detects up to 95% of cervical cancers, this assay provides an alternative for patients based on age, access, and risk factors. A recent large-scale study confirmed its sensitivity matches that of DNA-based HPV tests already in use.

Hologic's cervical health portfolio also includes the ThinPrep Pap Test and the Genius Digital Diagnostics System. Together, these tools support both cytology and molecular workflows, covering every step from sample collection to results. The company's focus on women's health aims to reduce the estimated 13,490 new invasive cervical cancer cases and 4,200 related deaths expected in the U.S. by 2026.

Regular screening and prompt follow-up of abnormal results remain critical in preventing cervical cancer deaths. Hologic's expanded testing options give healthcare providers more ways to tailor screening to individual patient needs.

The FDA's approval of the Aptima HPV Assay strengthens Hologic's position in cervical cancer detection. Clinicians now have three screening methods: Pap testing, HPV primary testing, and co-testing. These advancements aim to improve early diagnosis and reduce mortality rates through more personalized care.