Comparative Self-collection for Cervical Cancer Screening Pivotal Study
Start Date
7/9/2026
Completion Date
9/1/2026
Summary
To evaluate whether individuals drawn from the intended use population can successfully interpret and follow the IFU for the Mia by XytoTest self-collection device and perform a vaginal sample collection yielding sufficient cellular material for primary hrHPV screening. To assess the clinical performance of Mia self-collected vaginal specimens by evaluating agreement with paired clinician-collected cervical specimens for the detection of high-risk HPV, when both specimen types are analyzed using the cobas HPV Test (Roche Molecular Systems). Residual samples may be used to determine adequacy for additional assays that require vaginal and/or cervical specimens (such as mRNA E6 and E7 Biomarker Test, dual stain cytology).
Detailed Description
The purpose of this pivotal study is to generate the clinical evidence necessary to support FDA marketing authorization for the Mia device. Specifically, the study will evaluate the diagnostic agreement of Mia-collected self-samples against the standard of care clinician-collected method for primary hrHPV detection, confirm device safety, demonstrate that end users across a diverse population can use the device safely and effectively as directed.
Eligibility Criteria
Age Range: 25 years to 65 years
Interventions
Mia by XytoTest
Rovers Cervex-Brush
Conditions
Locations
ASR Arizona CGA
Phoenix, Arizona 85004
United States
Integrated Clinical Research
Sherman Oaks, California 91403
United States
Altus Clinical Research
Lake Worth, Florida 33461
United States
Zenacare Research
North Miami Beach, Florida 33169
United States
ASR Idaho CGI
Boise, Idaho 83702
United States
Boeson Research - Great Falls
Great Falls, Montana 59405
United States
Unified Women's Clinical Research
Raleigh, North Carolina 27607
United States
Innovo-Wilmington Health
Wilmington, North Carolina 28401
United States
Lyndhurst Clinical Research (Unified)
Winston-Salem, North Carolina 27103
United States
El Centro de Corazon
Houston, Texas 77012
United States
National Eagle Research
Lynnwood, Washington 98036
United States