Grail, Inc. · NASDAQ:GRAL
Grail — Technical Presentation (November 2021)
13 slides from Grail's technical presentation, November 2021
Slide 1: Performance of a Multi-Cancer Detection Test for Symptomatic Gynecological Cancers
Performance of a Multi-Cancer Detection Test as a Tool for Diagnostic Resolution of Symptomatic Gynecological Cancers Presenting Author: Minetta C. Liu, MD Mayo Clinic, Rochester, MN
Slide 2: Disclosure
Disclosure ● Uncompensated Consultant: GRAIL, LLC, a subsidiary of Illumina, Inc. ● The Mayo Clinic was compensated for Dr. Liu’s institutional responsibilities for the Circulating Cell-free Genome Atlas (CCGA) study protocol oversight and advisory board activities for GRAIL, LLC, a subsidiary of Il
Slide 3: Objective
Objective • To assess the performance of a multi-cancer detection test for detection of symptomatic gynecological cancers
Slide 4: Multi-Cancer Detection Test
Multi-Cancer Detection Test Blood-based test using cell-free DNA Cancer Signal Detected Diagnostic Diagnostic work-up resolution Multi-cancer Blood drawn Test report Cancer Signal detection test and shipped generated Not Detected ordered Multi-Cancer Detection Tests can: ● Detect the presence of can
Slide 5: The Circulating Cell-Free Genome Atlas Study (CCGA Study; NCT02889978)
The Circulating Cell-Free Genome Atlas Study (CCGA Study; NCT02889978) Prospective, multicenter, case-control, observational study Study Goals Study Design Develop and validate a blood- based multi-cancer detection test analyzing plasma cell-free DNA (cfDNA) to detect cancer signals across multiple
Slide 6: CCGA: Divided Into Pre-Specified Substudies
CCGA: Divided Into 3 Pre-Specified Substudies CCGA1 CCGA2 CCGA3 Further Assay Assay Refinement and Discovery1,2 Refinement and Classifier Development3 Clinical Validation4 Targeted Methylation Further refined for use Whole Genome (identified key informative as screening tool Methylation methylation
Slide 7: Study Participants
Study Participants CCGA Substudy 2 Validation Analyzable Set N=1308 (Cancer n=703; Non-cancer n=605) Applicable Population for Current Analysis Clinically Presenting Cancer n=518 Non-cancera n=398 Population with Gynecological Cancers n=60 (cervix, ovary, uterus, vagina, vulva) aNon-cancer status co
Slide 8: The Multi-Cancer Detection Test Performed with High Specificity
The Multi-Cancer Detection Test Performed with High Specificity Participant Group Cancer Signal Not Detected/ Specificity (95% CI) Total (n/N) Non-cancer participantsa 396/398 99.5% (98.2-99.9%) False Positive Rate: 0.5% Non-cancer participants with non-malignant 15/16 93.8% (71.7-99.7%) confounding
Slide 9: Sensitivity of the Multi-Cancer Detection Test Varied by Cancer and Clinical Stage
Sensitivity of the Multi-Cancer Detection Test Varied by Cancer and Clinical Stage Cancer Sensitivity in Participants with Clinically Presenting Cancer (95%-CI; Cancer Signal Detected/Total [n/N]) Stage I Stage II Stage III Stage IV All Stages 66.4% All Clinically 27.0% 58.8% 85.1% 92.5% (62.2%, 70.
Slide 10: Accuracy of Cancer Signal Origin Prediction was High
Accuracy of Cancer Signal Origin Prediction was High Cancer Cancer Signal Origin Prediction Accuracya (95% CI; Correct Signal Origin Detected/Total [n/N]) 91.7% All Clinically Presenting Cancerb (88.3-94.3%; 300/327) 100.0% Cervix (34.2-100.0%; 2/2) 100% Ovary (75.8-100.0%; 12/12) 88.9% Uterus (56.5
Slide 11: Conclusions
Conclusions In this subgroup analysis from the pre-specified, second CCGA sub-study: The multi-cancer detection test performed with: -High specificity -High accuracy for cancer signal origin prediction Sensitivity of the test varied depending on the cancer and clinical stage -Subgroups had limited s
Slide 12: Acknowledgments
Acknowledgments • Alan H. Bryce, MD, Mayo Clinic, Phoenix, AZ • Quan Zhang, GRAIL, LLC, a subsidiary of Illumina, Inc., Menlo Park, CA • Michael V. Seiden, MD, PhD, US Oncology Research, The Woodlands, TX • Jingjing Gao, PhD, GRAIL, LLC, a subsidiary of Illumina, Inc., Menlo Park, CA • David D. Thie
Slide 13: References
References • Klein E, et al. J Clin Oncol. 2018;36(15) suppl. DOI: 10.1200/JCO.2018.36.15_suppl.12021. • Razavi P, et al. Poster presented at: American Society for Clinical Oncology 2017 Annual Meeting; June 2-7, 2017; Chicago, IL. Abstract 11526. • Liu MC, et al. Ann Oncol. 2020;31(6):745-759. DOI: