Biop System's Safety and Performance
Biop System's Safety and Performance
Biop system's safety and performance in increased detection of High-Grade lesions of the
 cervical epithelium in women scheduled for colposcopy
Biop system's safety and performance in increased detection of high-grade lesions of the
 cervical epithelium in women scheduled for colposcopy.

 This is a multi-center, prospective, open label, non-randomized study to train the Biop
 System's algorithm and evaluate the safety and performance of the Biop system in women
 undergoing cervical colposcopy.
Inclusion Criteria:

 -  Female Age ≥ 22 years and ≤ 65.

 -  Referred for colposcopy, following abnormal cervical cytology;

 -  Participant provides signed informed consent

 Exclusion Criteria:

 -  Currently pregnant (through six weeks postpartum) or nursing

 -  Currently menstruating

 -  Previous hysterectomy

 -  Currently has intrauterine device (IUD)

 -  Cervical biopsy or therapeutic procedure since the referral cervical cytology,

 -  Diagnosed with diseases that may influence the color of the tissue, e.g., hepatitis,
 polycythemia vera.

 -  Known human immunodeficiency virus (HIV) infection or acquired immune deficiency
 syndrome (AIDS) (Applicable to training stage only)

 -  A known latex allergy

 -  Psychological instability, inappropriate attitude or motivation

 -  Cervical cytology tests within the prior seven days

 -  Use of vaginal medications within the last 48 h or photosensitizing agents within 72 h

 -  History of photosensitivity or other diseases affected by UV radiation,

 -  An observable and untreated gynecological infection.

 -  Previous history of CIN therapy