Clinical Research Directory

Inclusion Criteria: * Able to read or understand and give informed consent * Referral Pap test within 120 days * Scheduled for colposcopy based on the 2019 ASCCP Management Guidelines that fall within the 4% to 59% Immediate CIN3+ risk with the exception of women who lack a cervix or may be pregnant and are recommended to colposcopy.\* * Notes: The rationale for defining the referral inclusion criteria as women scheduled for colposcopy is that this group has been identified with having a significant likelihood of being diagnosed with CIN2+ over the two year period after being referred to colposcopy because of an abnormal screening test or tests. For example, the ALTS results showed that women with ASC-US plus high-risk HPV, LSIL, ASC-H, AGC and HSIL all had a likelihood of CIN2+ of approximately 10% to 20% or greater in the cases of ASC-H and HSIL (5). More recently, it has been shown that this threshold also carries with it a 4% or greater likelihood of immediate CIN3+ (12). Exclusion Criteria: * Pregnancy * Menstruating on the day of colposcopy and LuViva test * Radiation therapy to her genitourinary system within 1 year * Prior hysterectomy in which cervix was removed * Congenital anatomical cervical variant (e.g., double cervix) * Friable cervix at the time of the study (i.e., a cervix that bleeds easily upon minimal contact or trauma) * Post-coital or other significant bleeding at the time of the exam * Excessive cervical mucous or discharge that cannot be removed and is significant enough, in the opinion of the Investigator, to interfere with a Pap test or colposcopy, resulting from inflammation, bacterial infection or other sources * History of any photosensitizing disease or other disease affected by Ultra-violet radiation, (e.g., pophyria, Lupus Erythematosus). * Undergoing phototherapy * Recent use of photosensitizing agents, such as fluoroquinolones or retinoids * Under-screened populations - defined as those women who have not been screened within the past 5 years who also screen positive for any HPV genotype