MIA-COMP Pivotal Study: COMParative Self-Collection for Cervical Cancer Screening
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).
Clinical Trial Comparing the Self-test for Cervicovaginal Sample Versus Samples From Service Provider (Xyto-Ro)
SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening
Development of a Self-collection Device for Cervical Cancer Screening
Self Collected Sampling in Non-attendees Cervical Cancer Screening: DNA Test and Molecular Triage for HPV Positive Women