Hologic’s Aptima HPV Assay Receives the US FDA Approval for HPV Primary Screening
Shots:
- The US FDA has approved AptimaHPV Assay, an mRNA-based assay for clinician-collected HPV primary screening
- Approval follows completion of a real-world HPV screening study of 650,000+ women across US, showing the Aptima HPV Assay has clinically comparable sensitivity to an FDA-approved DNA-based HPV test & is effective for detecting CIN2+ & CIN3+ in primary screening
- The Aptima HPV Assay now supports all three FDA-approved, guideline-recommended cervical cancer screening options (Pap testing, HPV primary testing, & Pap + HPV co-testing), strengthening its comprehensive screening portfolio
Ref: Businesswire | Image: Hologic | Press Release
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