ConexiantFDA Expands HPV Primary Screening Options

The FDA approved the Aptima HPV assay for primary cervical cancer screening, the first mRNA-based test approved for this indication. With 13,490 cervical cancer cases and 4,200 preventable deaths expected in 2026, providers now have three distinct screening options.

⚖️ PROFESSIONAL IMPACT

• Aptima HPV assay targets messenger RNA rather than viral DNA, identifying active infections most likely to progress to cancer
• Real-world evidence study of 650,000 women across multiple health systems showed clinical comparability to DNA-based tests for detecting high-grade dysplasia
• Pap plus HPV co-testing remains most comprehensive option, detecting up to 95% of cervical cancers per published data
• Three approved strategies now available: Pap alone, Pap plus HPV co-testing, and primary HPV screening only

🎯 ACTION ITEMS

• Review practice protocols to determine optimal screening strategy for your patient population
• Update clinical workflows to incorporate primary HPV screening as third approved option
• Counsel patients aged 30-65 that co-testing remains most comprehensive cervical cancer screening
• Consider patient age, risk factors, and access when selecting between three screening modalities

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