SELF-CERV Pivotal Study: SELF-Collection for CERVical Cancer Screening

Exclusion Criteria

• •1. Participant has impaired decision-making capacity or is unable to provide informed consent.
• •2. Participant has undergone partial or complete hysterectomy including removal of the cervix.
• •3. Participant on whom any form of cervical tissue alteration or surgery has been performed within the prior \< 5 months, including: conization, loop electrosurgical excision procedure (LEEP), laser ablative surgery, or cryotherapy.
• •4. Participant is pregnant (based on self-reporting).
• •5. Participant who reports or is experiencing menstrual bleeding.
• •6. Participant is participating in another clinical study for an investigational device, drug, or biologic that, in the investigator's opinion, would interfere with the results of this study.
• •7. Any medical reason that, in the investigator's judgment, would disqualify the participant for a routine pelvic exam with cervical sample collection.