Hologic has received the US Food and Drug Administration (FDA) approval for its Aptima HPV assay for use in clinician-collected primary screening, further expanding its cervical health portfolio.
The human papillomavirus (HPV) test is said to be currently the only FDA-approved messenger RNA (mRNA)-based assay developed to identify infections with the highest risk of leading to cervical cancer.
With this FDA approval, Hologic now offers three major guideline-recommended methods: Pap testing, HPV primary testing, and Pap + HPV co-testing.