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

To demonstrate that participants who are representative of the intended use population can understand the Instructions for Use (IFU) and appropriately use the Teal self-collection device to collect adequate vaginal cells/material for use in primary hrHPV screening (primary outcome).

To produce sufficient primary hrHPV test results following self-collection, as compared to the current SoC method of HCP specimen collection, when paired samples are tested using FDA approved primary hrHPV assays (Roche cobas and/or BD OnClarity).

Primary Effectiveness Objective

• To evaluate the performance of a self-collect device for hrHPV detection as compared to standard of care (SoC) by:

• Agreement of hrHPV self-collected sample(s) as compared to HCP-collected sample results.
• Calculating the invalid rate of tested samples.

Group 1: Inclusion Criteria - General Population Group

• Participant is 25 to 65 years of age and willing to provide informed consent.
• Participant has an intact cervix.

Group 2: Inclusion Criteria - Enriched Population Group

• Participant is 25 to 65 years of age and willing to provide informed consent.
• Participant has an intact cervix.
• One or more of the below:

• Prior diagnosis of hrHPV within previous 6 months and/or
• Positive cervical Pap cytology result (ASCUS, ASC-H, LSIL, HSIL, SCC, AIS) within previous 6 months and/or
• Presenting for colposcopy/LEEP/excisional intervention

Exclusion criteria

- All Groups

• Participant has impaired decision-making capacity or is unable to provide informed consent.
• Participant has undergone partial or complete hysterectomy including removal of the cervix.
• 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.
• Participant is pregnant (based on self-reporting).
• Participant who reports or is experiencing menstrual bleeding.
• 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.
• Any medical reason that, in the investigator's judgment, would disqualify the participant for a routine pelvic exam with cervical sample collection.