Slide 1: Multimodal Spectroscopy as a Triage Test for Women at Risk for Cervical Neoplasia
MULTIMODAL SPECTROSCOPY AS A TRIAGE TEST FOR WOMEN AT RISK FOR CERVICAL NEOPLASIA: RESULTS OF A 1,607 SUBJECT PIVOTAL TRIAL Nahida Chakhtoura, M.D. Leo B. Twiggs, M.D. Chair, Department of Obstetrics and Gynecology University of Miami Miller School of Medicine Chief of Service, Jackson Memorial Hosp
Slide 2: Disclosure
Disclosure • The study sponsor was Guided Therapeutics, Inc. • None of the authors have any potential conflicts of interest to disclose • Speaker’s Bureau for GSK LuViva Advanced Cervical Scan
Slide 3: Pivotal Trial Clinical Sites
Pivotal Trial Clinical Sites University of Texas Southwest – Dallas, Texas Principal Investigator – Claudia Werner, MD Emory University School of Medicine – Atlanta, Georgia Principal Investigator – Lisa C. Flowers, MD University of Miami – Miami, Florida Principal Investigator – Leo B. Twiggs, MD /
Slide 4: Clinical Rationale: Cervical Cancer Screening
Clinical Rationale Cervical Cancer Screening Current screening and triage methods cause •Delays in diagnosing significant disease - 30% to 40% False Negative Rate •Excessive false positive rate – Only 20% of biopsies are positive for CIN2/3 Expensive - billions of dollars of unnecessary cost LuViva
Slide 5: LightTouch - Technology Advancement
LightTouch -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 LuViva Advanced Cervical
Slide 6: Potential Solution: Better Technology
Potential Solution: Better Technology Light In – Multiple wavelengths used to Spectrometer 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 7: LightTouch Cervical Spectroscopy
LightTouch Cervical Spectroscopy Cervical Neoplasia Detection System • 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 visualization an
Slide 8: LightTouch Study Design
LightTouch Study Design • Each subject served as own control • Referral Pap/HPV or other risk factor to qualify for study • On day of study, each subject had endocervical samples taken for Pap and HPV, followed by colposcopy and biopsy • Histology QA procedure used to reach diagnosis for each subjec
Slide 9: LightTouch Condensed Procedure
LightTouch Condensed Procedure • Prep subject per gynecological exam; remove any excessive blood or mucus • Calibrate LightTouch (20 seconds) • Using live video feed, insert hollow sight tube through speculum into vaginal canal until tube makes contact with cervix, cervix is in focus and cervical os
Slide 10: Definitions
Definitions • Final histology – Gold Standard – Pathology QA review involved blinded review by two independent expert pathologists – Up to two year histopathology follow-up after LightTouch study • Standard of Care – Includes Pap cytology, HPV testing and colposcopic impression LuViva Advanced Cervi
Slide 11: Study Group
Study Group • 1607 total • 1407 analyzed • Excluded women with discordant or insufficient histopathology, training cases (200) • 802 with two year follow up LuViva Advanced Cervical Scan
Slide 12: Up to Two Year Follow Up
Up to Two Year Follow Up Clinical Site Enrolled Follow up Data not Lost to Follow Up yet made Available Follow Up 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 University of
Slide 13: LightTouch Triage Test
LightTouch Triage Test Using the result of LightTouch • Normals-217/556 (39%) would not need further evaluation •CIN1- 176/585 (30%) would not need further evaluation •Significant cost savings LuViva Advanced Cervical Scan
Slide 14: Subjects reclassified as CIN 2+ based on histopathology review and follow up
Subjects reclassified as CIN 2+ based on histopathology review and two year follow up Number of Subjects Number Detected by Sensitivity with CIN 2+ Light Touch (%) Reclassified as CIN2+ based on 20 16 80.0 QA consensus histopathology* Reclassified as CIN2+ 31 28 90.3 based on up to 2 year follow up
Slide 15: 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 90.3% Follow up (0/31) (28/31) Total 61.4% 90.2% (81/132) (119/132) * Includes Pap cytology, HPV and colposcopy LuViva Advanced Cer
Slide 16: Study Conclusions
Study Conclusions • Abnormal cytology had little value as a triage tool unless it was HSIL (high grade) • LightTouch detected 91% of CIN2+ compared with 61% sensitivity for the current standard of care consisting of Pap, HPV and colposcopically directed biopsy • LightTouch would have reduced the num
Slide 17: LightTouch - Other Applications
LightTouch – Other Applications • Cervical mapping of lesions Cervical Maps of Subject with Dysplasia Biopsy sites marked with X’s • Primary Screening Device designed for primary screening Fast, immediate result; portable Test can be conducted by nurse or technician LuViva Advanced Cervical Scan
Slide 18: Thank You
Thank You LuViva Advanced Cervical Scan