Guardant Health, Inc. · NASDAQ:GH
Guardant Health — Technical Presentation (May 2024)
74 slides from Guardant Health's technical presentation, May 23, 2024
Slide 1: Shield is a Blood Based Colorectal Cancer Screening Test for Average-Risk Adults
CO-1 Shield is a Blood Based Colorectal Cancer Screening Test for Average-Risk Adults May 23, 2024 Molecular and Clinical Genetics Panel Guardant Health
Slide 2: Introduction
CO-2 Introduction AmirAli Talasaz, PhD Co-Chief Executive Officer Guardant Health
Slide 3: Colorectal Cancer Screening Saves Lives but Millions of Eligible Adults Are Not Screened
CO-3 Colorectal Cancer (CRC) Screening Saves Lives but Millions of Eligible Adults Are Not Screened ▪ CRC is 2nd leading cause of cancer-related death in US1 ▪ Early detection improves survival and reduces preventable CRC deaths2,3 ▪ Detection requires adherence to CRC screening test4,5 ▪ Despite cu
Slide 4: Current CRC Screening Landscape
CO-4 Current CRC Screening Landscape Primary Screening Options Second-Line Visualization Stool-Based Blood-Based Colonoscopy mt-sDNA mSEPT9 Prioritized option ▪ Poor device performance FIT ▪ 68% CRC sensitivity ▪ Invasive procedure ▪ 79% AN specificity ▪ Can prevent cancer HSgFOBT ▪ Required patient
Slide 5: Shield Would Add Effective Blood-Based Screening Option Alongside Stool-Based Tests
CO-5 Shield Would Add Effective Blood-Based Screening Option to Be Offered Alongside Stool-Based Tests Primary Screening Options Visualization Stool-Based Blood-Based Colonoscopy mt-sDNA Shield Prioritized option ▪ Non-invasive FIT ▪ Device performance in ▪ Invasive procedure range of stool-based ▪
Slide 6: A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening (NEJM)
Th NEW ENGLAND JOURNAL of MEDICINE ESTABLISHED IN 1812 MARCH 14, 2024 VOL. 390 NO. 11 A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening Daniel C. Chung, M.D., Darrell M. Gray II, M.D., M.P.H., Harminder Singh, M.D., Rachel B. Issaka, M.D., M.A.S., Victoria M. Raymond, M.S., Craig Eagl
Slide 7: Performance Supports Shield as a CRC Screening Option
CO-7 Performance Supports Shield as a CRC Screening Option CRC Sensitivity 83.1% (CI 72.2, 90.3) ECLIPSE1 Pivotal Study AN Specificity 89.6% (CI 88.8, 90.3) 1. Chung, 2024; CI = Confidence Interval; AN = Advanced Neoplasia, defined as CRC or Advanced Adenoma
Slide 8: Shield Effectively Detects CRC, in Range with Non-Invasive Modalities
CO-8 Shield Effectively Detects CRC, in Range with Non-Invasive CRC Screening Modalities mt-sDNA 92% Primary screening options Shield 83% Shield proposed as CRC primary screening option Sensitivity FIT 74% HSgFOBT 68% mt-sDNA 87% Shield 90% AN Specificity FIT 95% HSgFOBT 97% 0% 20% 40% 60% 80% 100%
Slide 9: Shield is an Effective CRC Detection Device but Has Limited AA Sensitivity
CO-9 Shield is an Effective CRC Detection Device but Has Limited AA Sensitivity and Limited Prevention AA Sensitivity 13.2% (CI 11.3, 15.3) ECLIPSE1 Pivotal Study High-Grade 22.6% Dysplasia (CI 11.4, 39.8) 1. Chung, 2024; AA = Advanced Adenoma
Slide 10: Shield's Advanced Adenoma Sensitivity on Lower End of Range of Stool-Based Tests
CO-10 Shield’s Advanced Adenoma Sensitivity on Lower End of Range of Stool-Based Tests mt-sDNA 42% Primary screening options Shield proposed as Shield 13% primary screening option AA Sensitivity FIT 24% HSgFOBT 11% 0% 20% 40% 60% 80% 100% ▪ Colonoscopy is the most accurate test for AA detection (up
Slide 11: Shield Proposed Intended Use and Indications for Use
CO-11 Shield Proposed Intended Use and Indications for Use The Shield test is a qualitative in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Shield Blood Collection Kit. Shield is indicated for colorectal cancer s
Slide 12: Shield Achieves Performance Established by Current Primary Stool-Based Screening Tests
CO-12 Shield Achieves Performance Established by Current Primary Stool-Based Screening Tests Current Primary Non-Invasive Stool CRC Tests Blood Test mt-sDNA FIT HSgFOBT Shield CRC Sensitivity1-5 92% 67 – 74% 68% 83% AN Specificity1-5 87% 95% 97% 90% AA Sensitivity1-5 42% 23 – 24% 11% 13% Adherence4,
Slide 13: Agenda
CO-13 Agenda Peter S. Liang, MD, MPH Assistant Professor, Department of Medicine Unmet Need Assistant Professor, Department of Population Health NYU Grossman School of Medicine Darya Chudova, PhD Shield Development Chief Technology Officer Guardant Health Daniel Chung, MD Medical Co-Director, Center
Slide 14: Additional Expert
CO-14 Additional Expert Jason Connor, PhD President & Lead Statistical Scientist ConfluenceStat, LLC
Slide 15: Benefits of CRC Screening and Need for Additional Options
CO-15 Benefits of CRC Screening and Need for Additional Options Peter S. Liang, MD, MPH Assistant Professor, Department of Medicine Assistant Professor, Department of Population Health NYU Grossman School of Medicine
Slide 16: CRC is Major Public Health Concern in US
CO-16 CRC is Major Public Health Concern in US 4th 2nd 152,810 53,010 Most diagnosed Most common Estimated adults Estimated deaths cancer1 cause of cancer diagnosed with from CRC in 20241 related death1 CRC in 20241 76% of CRC deaths occur in individuals not up to date with screening2 1. Siegel, 202
Slide 17: CRC is Well-Suited to Screening Due to Natural Progression of Disease
CO-17 CRC is Well-Suited to Screening Due to Natural Progression of Disease 17 ‒ 29 Years Total dwell time to CRC1 13 ‒ 25 Years 4 ‒ 5 Years Normal Adenomatous Advanced Pre-Clinical Clinical Polyp Adenoma Colorectal Colorectal Cancer Cancer 1. Knudsen, 2021
Slide 18: Early CRC Detection Improves 5-Year Survival
CO-18 Early CRC Detection Improves 5-Year Survival National Cancer Institute, SEER Database (2014 ‒ 2020) Percent of Cases by Stage at Diagnosis1* 35% 36% 23% 100 91% 80 74% Goal of CRC 5-Year screening is to 60 Relative detect cancer as Survival (%)1 40 early as possible, to allow for early 20 16%
Slide 19: USPSTF Guidelines Recommend CRC Screening for Adults Age 45 to 75
CO-19 USPSTF Guidelines Recommend CRC Screening for Adults Age 45 Years to 75 years1 Visualization Stool-Based Screening Options Colonoscopy mt-sDNA FIT HSgFOBT Colorectal Cancer1 Recommended Population1 Asymptomatic adults aged 45 ‒ 75 at average risk of CRC Benefits1 Reduction in CRC mortality CRC
Slide 20: Despite Current Screening Options, Screening Rates Remain Below Target
CO-20 Despite Current Screening Options, Screening Rates Remain Below Guideline Recommended Target 100 ~50 Million Screening Target Set by Leading US Adults Healthcare Organizations1,2 80% 45 ‒ 75 Years Old Not Up To Date with US Adults 58% CRC Screening4 60 45 ‒ 75 Years Old Up To Date with CRC Scr
Slide 21: Current Non-Invasive Primary Screening Tests Effectively Detect CRC
CO-21 Current Non-Invasive Primary Screening Tests Effectively Detect CRC Primary Non-Invasive CRC Tests mt-sDNA FIT HSgFOBT CRC Sensitivity1-4 92% 67 – 74% 68% AA Sensitivity1-4 42% 23 – 24% 11% 1. PMA P130017: FDA Summary of Safety and Effectiveness Data; 2. Imperiale, 2014; 3. Imperiale, 2024; 4.
Slide 22: Adherence to Non-invasive Stool-Based Screening Options Ranges from 28–71%
CO-22 Adherence to Non-invasive Stool-Based Primary Screening Options Ranges from 28 – 71% Primary Non-Invasive CRC Tests mt-sDNA FIT HSgFOBT CRC Sensitivity1-4 92% 67 – 74% 68% Adherence4-18 65 ‒ 71% 28 ‒ 68% 32 ‒ 67% ▪ Adherence: Proportion of individuals offered a screening test and elected to co
Slide 23: Standard of Care Screening Options Have Known Barriers Impacting Adherence
CO-23 Standard of Care Screening Options Have Known Barriers Impacting Adherence Primary Non-Invasive CRC Tests mt-sDNA FIT HSgFOBT CRC Sensitivity1-4 92% 67 – 74% 68% Adherence4-18 65 ‒ 71% 28 ‒ 68% 32 ‒ 67% ▪ Aversion to handling stool Barriers19-21 ▪ Complex, multiple step process can be challeng
Slide 24: Sensitivity x Adherence = Detection
CO-24 Sensitivity x Adherence = Detection Cancers Adherence Detected 0% 0 Cancers Sensitivity Adherence Detected 100% 50% 50% Cancers Adherence Detected 90% 90% Adherence = Individuals who were offered the screening test, elected to complete the test
Slide 25: Impact of Adherence on Probability of CRC Detection with Current Screening Tests
CO-25 Impact of Adherence on Probability of CRC Detection with Current Screening Tests Primary Non-Invasive CRC Tests mt-sDNA FIT HSgFOBT CRC Sensitivity1-4 92% 67 – 74% 68% Adherence4-18 65 ‒ 71% 28 ‒ 68% 32 ‒ 67% Estimated CRC Detection 60 ‒ 65% 19 – 50% 22 – 46% (CRC Sensitivity x Adherence) 1. P
Slide 26: CRC Screening Benefits Require Person to be Up-to-Date Over 3 Decades
CO-26 CRC Screening Benefits Require Person to be Up-to-Date at Regular Intervals Over 3 Decades Primary Non-Invasive CRC Tests mt-sDNA FIT HSgFOBT CRC Sensitivity1-4 92% 67 – 74% 68% Adherence4-18 65 ‒ 71% 28 ‒ 68% 32 ‒ 67% Screening Interval4 1-3 Years 1 Year 1 Year Lifetime Tests* 11-31 31 31 *Li
Slide 27: Summary of Unmet Need
CO-27 Summary of Unmet Need ▪ Despite available screening tests, ~50 million adults not up to date with CRC screening ▪ CRC is still 2nd leading cause of cancer-related death in US ▪ Patients and providers need additional CRC screening options that are convenient, noninvasive, and accurate ▪ Potenti
Slide 28: Shield Operating Principles and Device Development
CO-28 Shield Operating Principles and Device Development Darya Chudova, PhD Chief Technology Officer Guardant Health
Slide 29: Tumor-Derived cfDNA Fragments are Accessible in Circulation
CO-29 Cell-Free DNA (cfDNA) Fragments Originating from Tumor are Accessible in Circulation TO ▪ Cells shed DNA into circulation; CIRCULATION digested into smaller fragments Tumor cells known as cfDNA turn over ▪ Tumors contain significant number of genomic and epigenomic alterations ▪ Tumor derived
Slide 30: cfDNA Methylation Differentiates Individuals With and Without CRC
CO-30 cfDNA Methylation Differentiates Individuals With and Without CRC Methylation Levels Across Genomic Regions 50 CRC Methylation Individuals Quantification High 1 50 No CRC Individuals Low 1 Genomic Regions
Slide 31: Shield Classification Model Developed and Verified Using Large Independent Cohorts
CO-31 Shield Classification Model Developed and Verified Using Large Independent Development Cohorts Specificity Near Target of 90% CRC Detection Assay cfDNA Analysis in Informative Development Regions > 85% CRC Sensitivity at 90% AN Specificity CRC Sensitivity Model 1,470 CRC cases (all stages) Dev
Slide 32: Summary of Shield Device Development
CO-32 Summary of Shield Device Development ▪ Shield relies on well-established principles of cfDNA carrying tumor-associated DNA alterations into circulation ▪ Strong CRC detection capability demonstrated using > 1,000 independent CRC cases in pre-pivotal verification ▪ Analytical studies involving
Slide 33: ECLIPSE Study Design, Effectiveness, and Safety Results
CO-33 ECLIPSE Study Design, Effectiveness, and Safety Results Daniel Chung, MD Medical Co-Director, Center for Cancer Risk Assessment Director, High-Risk GI Cancer Clinic Massachusetts General Hospital Professor of Medicine, Harvard Medical School
Slide 34: ECLIPSE: Prospective, US Based, Multi-Center Study of Shield Performance
CO-34 ECLIPSE: Prospective, US Based, Multi-Center Study of Shield Performance to Detect CRC ▪ Study enrolled participants from October 2019 – September 2022 Day 1 Day 1 – Month 6 Recruitment Blood Draw Colonoscopy Individuals at average Processed to plasma at Abnormal risk for CRC central laborator
Slide 35: ECLIPSE Enrolled Average-Risk Participants Undergoing Routine Colonoscopy Screening
CO-35 ECLIPSE Enrolled Participants at Average Risk for CRC and Undergoing Routine Screening with Colonoscopy Inclusion Criteria Exclusion Criteria ▪ 45 ‒ 84 years old ▪ History of cancer, inflammatory bowel disease ▪ Average risk for CRC ▪ Hereditary predisposition to CRC or history of CRC in ▪ Int
Slide 36: Individuals Enrolled From Sites in United States
CO-36 Individuals Enrolled From 265 Sites in United States to Ensure Broad Demographic Representation ECLIPSE Study Sites N = 20 Academic / VA N = 245 Community VA = Veteran Affairs
Slide 37: Co-Primary Objectives Evaluated Sensitivity and Specificity Compared to Colonoscopy
CO-37 Co-Primary Objectives Evaluated Sensitivity and Specificity of Shield Compared to Colonoscopy Performance Goal: Sensitivity for CRC Lower-bound of 2-sided 95% CI > 65% Specificity for Performance Goal: Advanced Neoplasia Lower-bound of 2-sided 95% CI > 85% (AN) ▪ Performance goals based on pre
Slide 38: Secondary and Key Exploratory Objectives
CO-38 Secondary and Key Exploratory Objectives Secondary Objective ▪ Sensitivity for advanced adenoma (AA) Key Exploratory Objectives ▪ Positive predictive values (PPV) ▪ Negative predictive values (NPV) ▪ Performance by demographic and baseline characteristics ▪ Specificity, absence of any neoplast
Slide 39: Target Evaluable Sample Size for Co-Primary Objectives
CO-39 Target Evaluable Sample Size for Co-Primary Objectives ▪ Event-driven study design ▪ 68 CRCs provide 85% power for Target Evaluable Sample Size two-sided 95% CI > 65% for sensitivity Evaluable 68 Individuals with CRC ▪ Assuming true Shield sensitivity = 80.7% ▪ 7,000 individuals negative for E
Slide 40: Disposition
CO-40 Disposition Clinical Validation Cohort All enrolled participants allocated for N = 22,877 clinical validation n = 10,179 Not selected through prespecified down-sampling n = 2,440 Used for specificity interim futility analysis* Selected Participants Participants from all enrolled cohort randoml
Slide 41: Baseline Demographics and Patient Characteristics
CO-41 Baseline Demographics and Patient Characteristics Evaluable Cohort N = 7,861 Age, years; Mean (SD) 60 (9) 45 ‒ 49 8% Age Group 50 ‒ 69 70% 70+ 22% Sex Female 54% Ethnicity Hispanic 13% White 79% Black or African American 12% Race Asian 7% Other 2% SD = Standard Deviation
Slide 42: Shield Met Co-Primary Objective of CRC Sensitivity
CO-42 Shield Met Co-Primary Objective of CRC Sensitivity Colonoscopy Shield Positive Result Positive Result CRC Sensitivity N N % (95% CI) 83.1% Colorectal Cancer 65 54 (72.2, 90.3) Lower confidence bound > 65% performance goal
Slide 43: Shield Met Co-Primary Objective of Advanced Neoplasia Specificity
CO-43 Shield Met Co-Primary Objective of Advanced Neoplasia Specificity Colonoscopy Shield Negative Result Negative Result AN Specificity N N % (95% CI) Non-Advanced 6,680 5,982 89.6% Neoplasia* (88.8, 90.3) Lower confidence bound > 85% performance goal *Non-advanced adenomas, non-neoplastic finding
Slide 44: Secondary Endpoint: Shield Showed 13% Sensitivity for Advanced Adenoma
CO-44 Secondary Endpoint: Shield Showed 13% Sensitivity for Advanced Adenoma Colonoscopy Shield Positive Result Positive Result AA Sensitivity N N % (95% CI) 13.2% Advanced Adenoma 1,116 147 (11.3, 15.3) 22.6% High-Grade Dysplasia 31 7 (11.4, 39.8) 17.9% Villous Component 207 37 (13.3, 23.7) 17.2% ≥
Slide 45: Shield Performance Consistent Across Baseline Demographics
CO-45 Shield Performance Consistent Across Baseline Demographics CRC Sensitivity AN Specificity N = 65 N = 6,680 45 – 49 75% (3 / 4) 96% (554 / 580) 50 – 59 77% (10 / 13) 93% (2,470 / 2,657) Age Group, 60 – 69 88% (30 / 34) 90% (1,785 / 1,989) years 70 – 79 77% (10 / 13) 81% (1,136 / 1,405) 80+ 100%
Slide 46: Shield Sensitivity Correlated with Lesion Size and Stage
CO-46 Shield Sensitivity Correlated with Lesion Size and Stage CRC Sensitivity N = 65 Proximal Colon 89% (8 / 9) Tumor Location Distal Colon 84% (27 / 32) Rectum 79% (19 / 24) ≤ 9 mm 0% (0 / 6) Most Significant 10 – 19 mm 88% (7/ 8) Lesion Size ≥ 20 mm 92% (46 / 50) Missing 100% (1 / 1) Stage I* 55%
Slide 47: Shield Positive and Negative Predictive Values for CRC
CO-47 Shield Positive and Negative Predictive Values for CRC Observed Prevalence PPV NPV in ECLIPSE (95% CI) (95% CI) 3.03% 99.9% Colorectal Cancer 0.41% (2.7, 3.4) (99.9, 100.0) ▪ Given prevalence of CRC in average-risk population, PPV and NPV in range with expectations for CRC screening test
Slide 48: Shield Demonstrated 89.9% Specificity Without Any Neoplastic Findings
CO-48 Shield Demonstrated 89.9% Specificity in Individuals Without Any Neoplastic Findings Identified on Colonoscopy Colonoscopy Shield Negative Result Negative Result Specificity N N % (95% CI) 89.9% No Neoplastic Findings 4,514 4,057 (89.0, 90.7)
Slide 49: ECLIPSE Safety
CO-49 ECLIPSE Safety
Slide 50: Shield Safety Categorized into Direct and Indirect Risks
CO-50 Shield Safety Categorized into Direct and Indirect Risks Direct Risk Indirect Risk Health Risks False False from Performing Positives Negatives Shield
Slide 51: Shield Presents Low Direct Risk
CO-51 Shield Presents Low Direct Risk ▪ No unanticipated adverse device effects across 22,877 enrolled participants ▪ 43 AEs reported in ECLIPSE ▪ 70% (30/43) related to study phlebotomy including syncope, nausea, and hematoma ▪ 30% (13/43) unrelated, includes 2 unrelated SAEs
Slide 52: Potential for Inaccurate Result: False-Positive Shield Result
CO-52 Potential for Inaccurate Result in CRC Screening False-Positive Shield Result ▪ Could lead to colonoscopy ▪ Minimal added risk, as colonoscopy is recommended standard of care
Slide 53: 1-Year Data: Non-CRC Malignancy Rate Not Increased in False Positives
CO-53 Shield 1-Year Data Indicate Rate of Non-CRC Malignancies Not Increased in False Positive Results 1-year Follow-Up Data Number of Follow-up Rate of non-CRC Results Available malignancies Advanced Neoplasia N N % (95% CI) 640 0.8% (5/640) Shield False Positives 698 (92%) (0.3, 1.8) 5,502 0.9% (5
Slide 54: Potential for Inaccurate Result: False-Negative Shield Result
CO-54 Potential for Inaccurate Result in CRC Screening False-Negative Shield Result ▪ Could lead to forgoing other recommended screening ▪ 17% false-negative rate in range with other non-invasive CRC screening tests (e.g. 8 – 33%1-4) ▪ 100% sensitivity for detecting Stage II, III, and IV CRC in ECLI
Slide 55: Biology Allows for Longitudinal Testing to Reduce CRC Mortality
CO-55 Biology Allows for Longitudinal Testing to Intervene to Reduce CRC Mortality 17 ‒ 29 Years Total dwell time to CRC1 13 ‒ 25 Years 4 ‒ 5 Years Normal Adenomatous Advanced Pre-Clinical Clinical Polyp Adenoma CRC CRC Non-invasive Tests Allow Multiple Testing Interventions Screening Test Completio
Slide 56: Shield is a Safe and Effective Blood-Based Screening Test
CO-56 Shield is a Safe and Effective Blood-Based Screening Test for Patients Eligible for Average-Risk CRC Screening ▪ Shield met prespecified acceptance criteria for both co-primary endpoints of CRC sensitivity and AN specificity ▪ CRC sensitivity and AN specificity consistent across baseline demog
Slide 57: Clinical Perspective
CO-57 Clinical Perspective Monnie Singleton, MD CEO and Medical Director Singleton Health Center and Medical Center of Santee Orangeburg County, South Carolina
Slide 58: Colorectal Cancer Screening Improves Survival but Millions Not Screened
CO-58 Colorectal Cancer Screening Improves Survival but Millions of Eligible Individuals Not Screened ▪ Patients and providers need additional CRC screening options that are convenient, noninvasive, and accurate ▪ Potential benefits of an effective blood-based screening option ▪ Enhance patient acce
Slide 59: Shield Would Add Effective Blood-Based Option Alongside Guideline-Recommended Stool Tests
CO-59 Shield Would Add Effective Blood-Based Screening Option Alongside Guideline-Recommended Stool-Based Tests Shared Decision Making Visualization Non-Invasive Colonoscopy mt-sDNA FIT HSgFOBT Prioritized option Mailed Home Stool / Provided at Collection Office Patients do not decline stool tests,
Slide 60: Shared Decision-Making Plays a Crucial Role in Test Selection
CO-60 Shared Decision-Making Plays a Crucial Role in Test Selection to Maximize Adherence MAXIMIZE SCREENING MINIMIZE LIKELIHOOD ACHIEVE GUIDELINE FOLLOW-THROUGH OF NONADHERENCE SCREENING TARGETS Screening interventions higher Patient may not adhere with 80% screening target for among patients offer
Slide 61: NCCRT Manual Provides Key Facts for PCPs on Screening Options
CO-61 NCCRT Manual Provides Key Facts for PCPs when Discussing CRC Screening Options with Patients Colonoscopy HSgFOBT / FIT mt-sDNA ▪ Reduces death from CRC ▪ Reduces death from CRC ▪ Reduces death from CRC ▪ Can prevent cancer ▪ Safe, available, and easy to ▪ Safe, available, and easy to by removi
Slide 62: Shield Effectively Detects CRC, Performance in Range of Stool-Based Tests
CO-62 Shield Effectively Detects CRC, With Performance in Range of Primary Stool-Based Screening Tests Current Primary Non-Invasive Stool CRC Tests Blood Test mt-sDNA FIT HSgFOBT Shield CRC Sensitivity1-5 92% 67 – 74% 68% 83% AN Specificity1-5 87% 95% 97% 90% AA Sensitivity1-5 42% 23 – 24% 11% 13% 1
Slide 63: Shield is a Safe and Effective Test for Use as a Primary Screening Option
0 CO-63 Shield is a Safe and Effective Test for Use as a Primary Screening Option Similarly to Other Non-Invasive Tests Shared Decision Making Visualization Non-Invasive Colonoscopy mt-sDNA Shield FIT HSgFOBT Prioritized option Promote shared decision-making rather than restrict access to effective
Slide 64: Conclusion
CO-64 Conclusion Craig Eagle, MD Chief Medical Officer Guardant Health
Slide 65: Shield Data is in Range with Non-Invasive CRC Screening Modalities
CO-65 Shield IU is to Detect CRC, and Data is in Range with Non-Invasive CRC Screening Modalities mt-sDNA 92% Primary screening options Shield 83% Shield proposed as CRC primary screening option Sensitivity FIT 74% HSgFOBT 68% mt-sDNA 87% Shield 90% AN Specificity FIT 95% HSgFOBT 97% 0% 20% 40% 60%
Slide 66: Shield's AA Performance is in Lower-End Range of Stool Tests
CO-66 Shield’s AA Performance is in Lower-End Range of Performance of Stool Tests mt-sDNA 42% Primary screening options Shield proposed as Shield 13% primary screening option AA Sensitivity FIT 24% HSgFOBT 11% 0% 20% 40% 60% 80% 100% ▪ Colonoscopy is the most accurate test for AA detection (up to 95
Slide 67: Offering More Screening Options Increases Screening Rates Overall
CO-67 Offering More Screening Options Increases Screening Rates Overall with Minimal Impact on Current Tests 70% 69.9 Any CRC Screening 64.0 Colonoscopy 60% 47.7 50% CRC 40% Screening 43.0 Modality 30% (%) 20% 6.6 mt-sDNA 5.4 5.5 FIT / HSgFOBT / gFOBT 10% 2.5 1.7 CT Colonography 2.2 0.8 1.3 Sigmoido
Slide 68: CRC Screening Rates Increase When Blood Test is Offered
CO-68 CRC Screening Rates Increase When Blood Test is Offered Without Significant Test Substitution Liang, 2023 Coronado, 2024 1.8 x 2.4 x Increase Increase Number of N = 31 N = 305 Individuals Screened Blood Test FIT N = 17 Colonoscopy N = 130 Control Intervention Usual Care Intervention N = 178 N
Slide 69: Primary Test Choice (American Cancer Society quote)
CO-69 Primary Test Choice “ There is evidence that patients will have a preference for one type of screening test over others if provided sufficient information regarding these test attributes, although no single test appears to consistently dominate patient preferences, supporting a strategy of off
Slide 70: Committed to Patient and Provider Education for Informed Shared-Decisions
CO-70 Guardant Health Committed to Patient and Provider Education to Facilitate Informed Shared-Decisions ▪ Education outlining Shield’s performance (incl. AA performance), benefits and limitations including ▪ Implications of a “false positive” or “false negative” ▪ Repeat testing for “Normal Signal
Slide 71: Committed to Building Evidence Including Long-term Data
CO-71 Guardant Health Committed to Building Evidence Including Long-term Data ▪ ECLIPSE long-term 1- and 2-year cancer follow-up visits ▪ 92% of participants (N=7,169) completed 1-year follow-up ▪ Committed to further studies in collaboration with FDA, guideline committees, CRC screening experts, an
Slide 72: Shield is a Safe and Effective Primary Screening Option with Population Benefit
CO-72 Shield is a Safe and Effective Primary Screening Option with Population Benefit ▪ Shield’s performance in range of non-invasive stool tests ▪ Can increase impact of opportunistic health visit ▪ Patients do not decline stool tests, they do not complete them Shield as ▪ Sequential testing will h
Slide 73: Shield is a Blood Based Colorectal Cancer Screening Test for Average-Risk Adults
CO-73 Shield is a Blood Based Colorectal Cancer Screening Test for Average-Risk Adults May 23, 2024 Molecular and Clinical Genetics Panel Guardant Health
Slide 74: Which Screening Test Is Right for You?
Which Screening Test Test Type Is Right for You? K * an & /< Differences in Colon Cancer Screening 5 2 & g SS/ESESE Test Result vo « = « Can prevent colon cancer v * * * Test Process Requires you to handle stool (feces) - v v v You do the test once every three years - - - v A health care provider do