Development of a Self-collection Device for Cervical Cancer Screening

The purpose of this study is to collect design and user input on the safety and effectiveness of the Teal Health self-collection device for patient self-collection of cervicovaginal samples for use with FDA-approved in vitro diagnostics indicated for high risk Human Papillomavirus (hrHPV) screening.

Inclusion criteria

Group 1: Inclusion Criteria - General Population Group

• Subject is 25 to 65 years of age and willing to provide informed consent.
• Subject with intact cervix.

Group 2: Inclusion Criteria - HPV positive Population Group (HPV+ Enriched Group)

• Subject is 25 to 65 years of age and willing to provide informed consent.
• Subject with intact cervix.
• Prior diagnosis of high risk HPV and/or positive cytology and/or presenting for colposcopy.

Exclusion criteria

• Subject who reports current menstruation.
• Subject is pregnant (based on self-reporting).
• Subject has impaired decision-making capacity or unable to provide informed consent.
• Subject 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.
• Subject has undergone partial or complete hysterectomy including removal of the cervix.
• Subject has applied any chemical compounds to the cervical area within the 24-hours prior to study sample collection, including iodine, spermicide, douche, anti-fungal medications, generally, and specifically: Replens vaginal moisturizer and RepHresh vaginal hygiene products.
• Subject on whom any form of cervical tissue alteration or surgery has been performed within the prior year, including: conization, Loop electrosurgical excision procedure (LEEP), laser surgery, or cryosurgery.