Blood test for colon cancer
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www.epigenomics.com
2nd Generation Septin9 Test Epi proColon® 2.0
Dr. Gunter Weiss Vice President Product Development Dr. Jürgen Beck Senior Vice President Medical Affairs
Stockholm, 2011
2 | 25.10.2011
CRC accounts for ~ 10 % of total cancer burden
Lifetime risk of CRC is ~ 6 %
People diagnosed with colon cancer:
Facts about Colorectal Cancer
•…413,000 citizens in Europe are newly diagnosed every year
•List of people diagnosed with colorectal cancer
•From Wikipedia, the free encyclopedia
3 | 25.10.2011
•P <0.001
screen detected
not-screen detected
Survival rate for colorectal cancer with and without screening Source: Gupta et al.: Changing trends in the incidence, stage, survival, and screen-detection of colorectal cancer: A population-based study. Clinical Gastroenterology and Hepatology 2005; 3:150-158. Winawer et al.: Colorectal Cancer Screening: Clinical Guidelines and Rationale. Gastroenterology 1997;112:594–642.
5-year survival
Local disease
With screening
73% 68%
Without screening
46% 40%
CRC Screening Saves Lives
4 | 25.10.2011
Blood-based Septin9 Test: Screening the Unscreened
Why patients will want it:
non-invasive
no dietary/medication restrictions
quick and easy, done anytime
affordable/reimbursable
Why doctors will use it:
performance
body of evidence
easy to explain/perform
helps with screening resistant patients
encourages colonoscopy
screened
Current CRC Screening Compliance in the EU
Septin9
~90% EU citizens are unscreened!
References:
Zavoral et al.: Colorectal cancer screening in Europe. World J Gastroenterol 2009 Dec 21; 15(47): 5907-5915.
5 | 25.10.2011
Epi proColon 2.0 : A 2nd Generation Septin9 Test
BETTER Higher sensitivity Improved accuracy Improved clinical performance
EASIER Fewer components Fewer handling steps
FASTER 8 hours time to result Less hands-on time Easier to automate
Available Soon in Europe
6 | 25.10.2011
EASIER: Components
smaller volumes
less components
GMP quality
7 | 25.10.2011
1.0 Assay 2 days
FASTER: Work Flow
•STEP 1
•3.5 ml Blood Plasma
•STEP 2
•DNA Isolation
•STEP 3
•Bisulfite Conversion
•STEP 4
•Duplex real-time PCR •DATA ANALYSIS
< 8h 2.0 Assay
shorter reaction
fewer handling
steps
8 | 25.10.2011
BETTER: Analytical Performance
fewer handling
steps
PCR Replicates Limit of Detection (LOD)
one 23 pg/ml
two 10 pg/ml
three <6 pg/ml
higher sensitivity
9 | 25.10.2011
•Principle of the Test
Real-time PCR based test
Detection of cell-free tumor DNA in blood
Biomarker: methylated SEPT9 gene
13 published retrospective clinical studies for Septin9 performed, >4,300 subjects tested
Prospective clinical screening study in ~8,000 subjects
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Clinical Application of the Septin9 Test
•Asymptomatic
•patient
•10 ml
• blood •Septin9 test
•Colonoscopy
•Clinical
•workup
•Positives •Positives
•Negatives •Negatives
•Repeat blood test conducted at intervals
•consistent with practise guidelines and other
•non-invasive CRC screening tests, e. g. annually.
•Next CRC screening colonoscopy
•to be performed according to
•guidelines, e. g. 10 years later.
11 | 25.10.2011
# patients # positive positive fraction
NED 149 1 1%
CRC 98 79 81%
Stage I 27 18 67%
Stage II 29 25 86%
Stage III 31 27 87%
Stage IV 11 9 82%
Stage Specific Performance
specificity 99%
sensitivity 81%
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Method Specificity Sensitivity Negative
Predictive Value
Positive Predictive Value5
2nd Generation Septin9 Epi proColon® 2.0 1 99.3% 80.6% 99.9% 45.7%
Guiac Fecal-Occult Blood Test2
97.7% 37.1% 99.6% 10.1%
OC-Sensa Micro qFIT1x3
93.7% 69.2% 99.8% 7.5%
OC-Sensa Micro qFIT3x4
89.8% 84.6% 99.9% 5.6%
1 Tetzner et al. UEGW 2011, 2 Allison et al. 1996 NEJM, 3 + 4 Park et al. 2010. Am. J. Gastro. 5 Orange figure: CRC with positive test result, grey figure: healthy with positive test result assuming a prevalence for CRC of 0.7%.
Comparison of Clinical Performance of CRC Screening Methods
13 | 25.10.2011
Method Sensitivity@Specificity
Current Compliance4
Detected CRC in 1 Million
Patients5
Tomorrow’s Compliance
Detected CRC in 1 Million
Patients5
Blood-Based Epi proColon® 2.0 1 81%@99% NA 0 29%6 1,644
Guiac Fecal-Occult Blood Test2
37%@98% 16% 414 16% 414
Colonoscopy3 97%@98% 30% 2,037 30% 2,037
2,451 4,095 1 Tetzner et al. UEGW 2011.
2 Allison et al. 1996 NEJM.
3 Davies RJ et al. (2005). Nat Rev Cancer 5:199-209.
4 Altenhofen l et al. Jahresbericht Zi 2008.
5 Assuming a prevalence for CRC of 0.7%.
6 Telephone survey Colorectal Cancer Alliance. CCA Denver 2011.
CRC Detection Rate with CRC Screening
+67%
14 | 25.10.2011
The New Epi proColon® 2.0 Early Detection Assay
Unmatched performance in non-invasive colorectal cancer detection
(PPV 45%, sensitivity of > 80% @ 99% specificity)
Unmatched convenience for the patient (blood-based)
Conclusions
Available Soon in Europe
15 | 25.10.2011
Thank You for Your Attention
•Berlin, Germany •Seattle, WA, U.S.A.
16 | 25.10.2011
Backup
2 of 3 Algorithm
Specificity 99%
Sensitivity 81%
1 of 3 Algorithm
Specificity 85%
Sensitivity 95%
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