Indications for Use

LuViva is intended for use after…

  • abnormal cytology and/or  positive HPV findings and/or other risk factors
  • to triage women aged 16+ for additional evaluation prior to colposcopy and biopsy

LuViva Paradigm update less color

LuViva is to be used on a referred population of women following an abnormal pap test, positive HPV test, or other symptomatic referral cause.  The current cervical cancer screening paradigm has 100% women who have received an abnormal results from their initial cervical cancer screening method go onto diagnostic testing, which can include HPV testing, colposcopy, and/or biopsy.  When adding LuViva to the cervical cancer screening process, LuViva acts as a triage point identifying women that can return to routine screening from those that should go onto further diagnostic testing.  Based on clinical trials, 20% of women being referred onto additional testing will actually have disease. Of the remaining 80%, LuViva would be able to remove 35-40% of them from additional, unnecessary testing.

Contraindications

  • Pregnancy
  • Menstruation on the exam day
  • Radiation therapy to the genitourinary system within a year of the exam
  • Prior hysterectomy 
  • Congenital anatomic cervical variant (eg, double cervix) 
  • Friable cervix 
  • Postcoital or other significant bleeding 
  • Excessive cervical mucus or discharge that cannot be removed or the operator believes is significant enough to interfere with a cytology or colposcopy 
  • History of photosensitivity or other disease affected by ultraviolet radiation 
  • Phototherapy 
  • Recent use of photosensitizing agents 
  • Referral test indicating risk of severe dysplasia