Hologic’s Aptima assay secures FDA approval for HPV primary screening

With this FDA approval, Hologic now offers three guideline-recommended methods: Pap testing, HPV primary testing, and co-testing.

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.

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