Slide 1: Multimodal Spectroscopy as a Triage Test for Women at Risk for Cervical Neoplasia: Follow Up Data
Multimodal Spectroscopy as a Triage Test For Women at Risk For Cervical Neoplasia: RESULTS OF FOLLOW UP DATA Nahida Chakhtoura Leo B. Twiggs University of Miami Miller School of Medicine Medicine, Jackson Memorial Hospital Edward Wilkinson University of Florida Stephen Raab University of Colorado Lu
Slide 2: Disclosure Information
Disclosure Information • The study sponsor was Guided Therapeutics Inc Therapeutics, Inc. • None of the authors have any potential conflicts fli t off interest i t t tto di disclose l • Dr. Chakhtoura is a member of the Speaker’s Bureau of GSK LuViva Advanced Cervical Scan
Slide 3: LightTouch Technology Advancement
LightTouch -Technology Technology Advancement • Advances in the electro-optics, illumination sources and sensors • Efficiencies in performance and cost of multimodal hyperspectroscopy (MHS) • Development of clinically relevant and convenient devices for the detection of cervical neoplasia p LuViva A
Slide 4: Potential Solution: Better Technology
Potential Solution: Better Technology Light In – Multiple wavelengths used Spectrometer to penetrate different tissue depths Results 1. Fluorescence Spectra - Reveal metabolic changes associated with neoplasia 2. Reflectance Spectra – Reveal morphological changes associated with neoplasia LuViva Adv
Slide 5: Background
Background Challenge in evaluating efficacy of new technology is verification bias – How gold is the gold standard in verifying presence or absence of disease? ALTS reduced verification bias* bias • Expert colposcopy • Quality controlled consensus histopathology • Up to 2 year follow up *ALTS Group.
Slide 6: Up to Two Year Follow Up
Up to Two o Year ea Follow o o Up Clinical Site Enrolled Follow up Data not Lost to Follow Up yet made Available Follow Upp Data University of Texas Southwest 234 64 125 45 Emory University School of 348 48 81 219 Medicine University of Miami 313 0 115 198 University of Connecticut 394 0 164 230 Uni
Slide 7: Clinical Evaluation of Multimodal Cervical Spectroscopy: Mitigation of Verification Bias
Clinical Evaluation of Multimodal Cervical Spectroscopy: Mitigation of Verification Bias • Expert p colposcopy p py with adequacy q y data collected • Multiple steps to detect cervical lesions (e.g., Lugol’s in addition to acetic acid) • Automated detection of possible interfering factors (e.g., amb
Slide 8: Subjects Reclassified as CIN 2+ Based on Histopathology Review and Follow Up
Subjects S bj t reclassified l ifi d as CIN 2+ b basedd on histopathology review and two year follow up Number of Subjects Number Detected Sensitivity with CIN 2+ by Light Touch (%) Reclassified R l ifi d as CIN2 CIN2+ based on 20 16 80.0 QA consensus histopathology* Reclassified as CIN2+ 31 28 90.3
Slide 9: MHS Detected 46.9% More CIN2+ Than the Standard of Care
MHS Detected 46.9% More CIN2+ Than the Standard of Care (n=802) Follow up Standard of MHS Procedure Care* Histopathology 80.2% 90.1% Review (81/101) (91/101) 2 Year 0.0 0 0 90.3% 90 3% Follow up (0/31) (28/31) Total 61.4% 90.2% (81/132) (119/132) * Includes Pap cytology, HPV and colposcopy LuViva Ad
Slide 10: Comparison of MHS Study Follow Up Results with ALTS
Comparison of MHS Study Follow Up Results with ALTS ALTS/Immediate ALTS/HPV MHS Pivotal Study Colposcopy Arm Triage Arm HPV MHS Number of cases 1163 1161 802 802 with follow up Number of 189 186 45* 45* cumulative CIN2/3 Sensitivity 53.6 72.3 77.8 86.7 (CIN3 only) (CIN3 only) (CIN2/3) CIN2/3) * Excl
Slide 11: Conclusions – MHS Follow Up Study
Conclusions – MHS Follow up St d Study • Sensitivity for CIN2/3 of current standard of care was 61.4% (81/132) • Similar to ALTS - 65% for CIN3 • MHS detected 46.9% more CIN2+ than the standard of care (p < .001) • MHS detected 86.3% of cumulative CIN2+ missed by the current standard of care LuViva
Slide 12: Thank You
Thank You The National Cancer Institute The Georgia Research Alliance LuViva Advanced Cervical Scan
Slide 13: LightTouch Cervical Spectroscopy
LightTouch Cervical Spectroscopy Cervical Neoplasia p Detection System y • Measures fluorescence and reflectance spectra at multiple points on the cervix in one minute • Immediate, objective result • Low cost device and single patient use disposable • Built in video colposcope – permits see and trea