Development of a Self-collection Device for Cervical Cancer Screening

Evaluation of a novel self-collection device for cervical cancer screening.

Inclusion Criteria:Group 1: Inclusion Criteria - General Population GroupSubject is 25 to 65 years of age and willing to provide informed consent.Cis woman with intact cervix or trans man 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.Cis woman with intact cervix or trans man 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.