The Use of the LuViva Advanced Cervical Scan to Identify Women at High-Risk for Cervical Neoplasia

Prior treatment

• Radiation therapy to her genitourinary system within 1 year
• Prior hysterectomy in which cervix was removed

Other illness

• 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).

Other

• Pregnancy
• Menstruating on the day of colposcopy and LuViva test
• 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)
• 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

• 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).