Stool DNA Screening for Colorectal Cancer. David Ahlquist, MD Carrol M Gatton Professor of Digestive Science Mayo Clinic, Rochester MN
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1 Stool DNA Screening for Colorectal Cancer David Ahlquist, MD Carrol M Gatton Professor of Digestive Science Mayo Clinic, Rochester MN
2 Disclosures Relationship with Exact Sciences Mayo Clinic Equity investor Licensed technologies Dr. Ahlquist Scientific Advisor Inventor of licensed technology Research collaborator 2
3 Stool DNA Testing A more thoughtful approach and anyone can do it!
4 Effective Detection Effective Detection = S x C x A S = sensitivity C = compliance A = access 4
5 CRC Screening Tool Ideal Features Accurate detection Curable stage CRC Critical precursors (adenoma + serrated) Both R & L sides Noninvasive & safe Simple & convenient No prep or restrictions Affordable Widely distributable S C A 5
6 Stool DNA Testing High detection rates for CRC & precancer Unaffected by site Noninvasive No cathartic preparation No diet or med restriction Off-site collection Widely accessible Biologically rational Muco-cellular layer * * Ahlquist et al. Hum Pathol :51
7 Optimized Stool DNA Test Simple device for collection & mailing Buffered, stable >2 wks Targets multiple markers Methylated BMP3 & NDRG4 Mutant KRAS β-actin (human DNA) Hemoglobin (FIT) Sensitive multiplex DNA assay (QuARTS) Automated
8 Automated Stool Assay Developed by Exact Sciences Lidgard et al. CGH-Online 2013
9 Next Generation Stool DNA Testing for Detection of Colorectal Neoplasia: Early Clinical Evaluation Ahlquist, Zou, Domanico, Mahoney, Yab, Taylor, Thibodeau, Rabeneck, Kinzler, Vogelstein, Bjerregaard, Laurberg, Sørensen, Berger, Lidgard Multicenter casecontrol study N=678 CRC 253 Adv ad 130 Freezer archived specimens Stool DNA test Non-optimized prototype Covariate analyses 2012; 142:248 9
10 Cancer & Adenoma Detection Effect of Lesion Site Proximal Distal % Cancer Adenoma 1 cm 10
11 Sensitivity (%) Adenoma Detection Effect of Size P< ~ 1 >1 >2 >3 Adenoma Size (cm) 11
12 Detection of Sessile Serrated Polyps >1cm From Screen Setting: sdna vs FIT Heigh et al. GI Cancer Symposium (San Francisco 1/2013) 12
13 Factors NOT Affecting DNA Stool Markers Sex, Race, or Geography Smoking Alcohol NSAIDs Personal hx polyps FHx CRN Body mass Ahlquist et al. J Mol Biomark Diagn
14 Optimized & Automated Stool DNA Test Case-Control Study Lidgard et al. CGH-Online 2013 Prospective, blinded, multicenter Cases CRC 93 Adv precancer* 114 Controls Normal colonoscopy 641 * Advanced adenoma + serrated polyp >1cm
15 Cancer Detection Effect of Stage 95% 100% No stage effect p = NS 97% 96% 100% Overall sensitivity 98% 15
16 Adenoma Detection Effect of Size Sensitivity for HGD* 83% *94% found In lesions >2cm
17 Optimized Stool DNA Test Screen Setting Multicenter study completed (Imperiale et al) Cross-sectional, >10,000 Stools prior to screening colonoscopy Stool DNA vs FIT Topline data only Sensitivity CRC 92% Adv precancer* All 42% >2cm 66% (specificity 87%**) Currently under FDA & CMS review in USA * Adv adenoma + serrated polyp >1cm ** Normal includes polyps <1cm Superiority over FIT, all categories
18 Hypothetical Programmatic Sensitivity of Next Gen Stool DNA Testing Screen Frequency q 3 yr Cumulative Sensitivity, % Lesion Cohort Large Precancer* CRC Screen Screen (99) Screen * 1-2cm size cutoff, assume volume doubling time 6 yrs 18
19 Stool DNA Test Is More Accurate Than Plasma Septin 9 Test in Detecting Colorectal Neoplasia DA AHLQUIST, WR TAYLOR, DW MAHONEY, H ZOU, M DOMANICO, SN THIBODEAU, LA. BOARDMAN, BM BERGER, GP LIDGARD CGH 2012;10:272 Cancer Large Adenomas False Positives: sdna 7% pseptin9 27% 19
20 Plasma Septin9 in Screening Setting The PRESEPT Study Church et al. Gut Online 2/13/ asymptomatic persons, >50 yrs, prior to screening colonoscopy 91% specificity CRC (53) 48% Stage I 35% Stage II 63% 45% Stage III 46% Stage IV 77% Adv Ad (314) 11% HGD 12%
21 Conceptual Model Plasma Markers (vascular invasion) Distant metastasis? Stool Markers (exfoliation) Large Pre-cancer I II III IV Cancer 21
22 Stool Collection Not a barrier to compliance Much easier than bowel prep & completely noninvasive With pt-friendly collection device, return rate >95% Ann Intern Med 1988;108:607 Key determinants of screen test selection* Accuracy/effectiveness Convenience 3 rd party coverage *Mayo patient survey (unpublished) 22
23 Comparison of Tests FS Colo VC Cap sdna Accurate detection CRC + precursors - + +? + Both R & L sides - +/- +? + Operator-independent Noninvasive & safe Simple & convenient No prep or restricts Affordable???? + Widely distributable UGI Screen Capacity
24 Stool DNA Testing The Clear Winner!
Noninvasive Molecular Detection of Colorectal Neoplasia
Disclosures Noninvasive Molecular Detection of Colorectal Next Generation Approaches David Ahlquist August 7, 29 Relationship with Exact Sciences Mayo Clinic is equity investor Potential for future royalties
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