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

SELF-CERV Pivotal Study: Method Comparison of Self-collection Using the Teal Wand Self-Collection Device and HCP (Health Care Provider) Cervical Collection for Detection of High-risk HPV (hrHPV) for Cervical Cancer Screening

The goal of this method comparison study is to compare the detection of hrHPV collected using the Teal Wand Self-Collection device to hrHPV detected from HCP (health care provider) cervical collection using primary HPV testing assays.

Participants will be asked to use the Teal Wand to provide a self-collected sample prior to a healthcare provider collected sample to be tested for hrHPV. Secondary measure will include usability and preferences.

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

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

Group 2: Inclusion Criteria - Enriched Population Group

1. Participant is 25 to 65 years of age and willing to provide informed consent.

2. Participant has an intact cervix.

3. 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

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.