NCI Cervical Cancer ‘Last Mile’ Initiative (LMI)
Facilitating discussions for regulatory approvals for self-sampling
- Reviewing evidence on self-sampling to inform regulatory pathways
- Facilitation of discussions between FDA and HPV assay manufacturers seeking approvals for self-sampling approaches for primary HPV testing
“Self-sampling for HPV testing to Improve Cervical Cancer Prevention” (‘SHIP’) Trial
- Nationwide multicenter clinical trial and associated studies
- Independent evaluation of multiple self-sampling devices and assays for usability, acceptability, accuracy, and utility for implementation
Disseminating evidence on self-sampling to change and inform clinical practice
- Partnerships with professional societies to update clinical practice guidelines after FDA approvals for self-sampling
- Creating publicly-accessible repository of resources on self-sampling