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).
⁃ Group 1: General Population Group
• Participants are 25 to 65 years of age and willing to provide informed consent.
• Participants have an intact cervix.
⁃ Group 2: Enriched Population Group
• Participants are 25 to 65 years of age and willing to provide informed consent.
• Participants have an intact cervix.
• One or more of: prior diagnosis of hrHPV within previous 6 months; abnormal cervical Pap cytology result of HSIL or higher (HSIL, AIS, or invasive carcinoma per the Bethesda 2014 system) within previous 6 months; and/or presenting for colposcopy/LEEP/excisional intervention.