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Diagnostics for the early detection 
and prevention of colon cancer 
Corporate Presentation 
September 2014
Safe Harbor Statement 
Certain statements made in this news release contain forward-looking statements within the meaning of Section 27A of the 
Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, that are 
intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on 
certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of 
forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” 
“anticipate” or other comparable terms. Forward-looking statements in this news release may address the following subjects 
among others: statements regarding the sufficiency of our capital resources, expectations concerning our ability to secure 
and the timing of reimbursement for our Cologuard test, our estimated reimbursement amounts, our estimates of the 
available market size and our potential penetration, expected research and development expenses, expected general and 
administrative expenses and our expectations concerning our business strategy. Forward-looking statements involve 
inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking 
statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in 
Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed 
Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. We urge you to consider those 
risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon 
any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal 
securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking 
statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in 
events, conditions or circumstances on which any such statement is based. 
1
OUR MISSION 
To partner with healthcare providers, 
payers, patients and advocacy groups 
to help eradicate colorectal cancer 
2
Exact Sciences Overview Executing on the Mission 
• Cologuard® is an FDA-approved, breakthrough, non-invasive colorectal 
cancer screening test developed with Mayo Clinic 
• Uses a combination of DNA markers 
– Detects 92% of cancers 
• First time in history FDA approved a technology, CMS proposed national 
coverage on the same day 
– FDA approved on August 11, 2014 
– CMS proposes 3-year interval in preliminary coverage decision 
• Multibillion-dollar global opportunity 
• 120-person sales force and growing 
3
Cologuard® FDA-approved, non-invasive screening test 
FPO 
4
5 
Cologuard FIT Improvement P Value 
Cancer 
detection 
92% 
(60/65) 
73% 
(48/65) 
25% 0.002 
Advanced 
Adenoma 
detection 
42% 
(321/757) 
24% 
(180/757) 
78% <0.001 
N Engl J Med 2014;370:1287-97. DOI: 10.1056/NEJMoa1311194 (Imperiale)
Cologuard Indications for Use 
Cologuard is intended for the qualitative detection of colorectal 
neoplasia associated DNA markers and for the presence of 
occult hemoglobin human in stool. A positive result may indicate 
the presence of colorectal cancer (CRC) or advanced adenoma 
(AA) and should be followed by diagnostic colonoscopy. 
Cologuard is indicated to screen adults of either sex, 50 years 
or older, who are at typical average-risk for CRC. Cologuard is 
not a replacement for diagnostic colonoscopy or surveillance 
colonoscopy in high risk individuals. 
6
Center for Medicare & Medicaid Services Update 
7 
• 3-year interval proposed by CMS 
• Preliminary pricing expected late Aug or Sept 
• Final national coverage, pricing expected Q4 
CMS
Proposed Cologuard reimbursement 
crosswalk 
CologuardTM Crosswalk Proposed Payment 
2 DNA methylation 
markers 
8 
81315 
ML/RARalpha 
$282.83 
7 DNA mutation 
markers 
81275 
KRAS 
$197.48 
Fecal hemoglobin 
82274 
FIT 
$21.70 
Total $502.01
Mayo Clinic first system to adopt Cologuard 
• ~600 primary care physicians 
• 1.2 patients seen annually 
“…A critical step in beating this 
prevalent and preventable 
cancer.” 
- Vijay Shah, M.D., chair, 
gastroenterology & hepatology 
9
Stool DNA presently included in key cancer 
screening guidelines 
sDNA testing included in American 
Cancer Society screening guidelines in 
2008 
• Recommended for use by average-risk 
patients 
 Included in American College of 
Gastroenterology guidelines 
• 3-year interval for stool DNA 
 U.S. Preventative Services Task Force 
• 2015 update expected 
• If A/B rating, then all commercial 
payers must cover test 
10
Major opportunity to improve colorectal cancer screening 
The most preventable, yet 
least prevented cancer. 
– Journal of the National Cancer Institute 
Source: J Natl Cancer Inst. 2009; 101:1225-1227 (Itzkowitz) 
11
Detection and removal of polyps prevents cancer1 
Pre-cancerous polyp 
Stages of colon cancer 
10-15 
years2 
12 
1Source: N Engl J Med 2012;366:687-96 (Zauber) 
2Source Gastro 1997;112:594-692. (Winawer)
Colorectal cancer: the second-leading U.S. cancer killer 
136,830 
Annual U.S. cancer mortality 
14,270 
29,480 
39,590 
40,430 
50,310 
159,260 
4,020 
Cervix Ovary Prostate Pancreas Breast Lung 
Source: ACS Cancer Facts & Figures 2014; all figures annual 
new U.S. cases 
50,310 
U.S. deaths 
Colorectal 
13
Late-stage detection leads to poor outcomes 
60% 
of cancers are 
detected late stage 
Sources: CA Cancer J Clin 2008; 58:130-160 (Levin, B); 
ACS Colorectal Cancer Facts & Figures 2011-13; seer.cancer.gov/faststats 
14
Colorectal cancer costs significant and rising 
$14B 
annual treatment costs 
Source: J 15 Natl Cancer Inst. 2011; 103:1-12 (Mariotto)
Low screening rate contributes to colorectal cancer deaths 
~50% 
of Americans are current for 
recommended colonoscopy 
screening 
Source: 16 ACS Cancer Prevention & Early Detection Facts & Figures 2013
American Cancer Society Goal: 80% by 2018 
Colorectal 
Cervical 
83% 
65% 
Cancer screening rates 
17 ACS Cancer Prevention & Early Detection Facts & Figures 2013; Company estimates
Current U.S. screening of average-risk patients 
10.2M 
fecal blood tests 
Source: CPT/HCPCS/ICD-9 Codes by Aileron Solutions; 
Company estimates 
4.3M 
screening colonoscopies 
14.5 million tests per year 
55% FOBT 
FIT 45% 
18
Cologuard U.S. market opportunity 
80M 
eligible for screening 
(>50 years old) 
Source: Company estimates 
>$2B 
Potential U.S. market 
30% penetration 
19
Despite inadequacies, FIT rapidly gained market share 
over FOBT 
• Strategy of converting systems and high-volume users 
• Insignificant sales & marketing investment 
• Sensitivity advantages over FOBT 
• Without compliance engine 
2% 
45% 
2004 2008 2012 
20 Sources: Company estimates and CMS, Medicare Part B, Colorectal Cancer Screening
Cologuard commercial strategy 
21 
Drive 
demand 
Provider • Physician & system 
outreach 
• Medical education 
• Publications 
Promote 
compliance 
Patient • Direct advertising 
• Public relations 
• Compliance engine 
Secure 
payment 
Payer • CMS parallel review 
• Managed care team
Cologuard launch underway 
22 
Large 
sales 
team 
• 120 experienced 
sales leaders 
• Training complete 
Cutting-edge 
lab 
& support 
Targeted 
marketing 
• Strong program of 
PR, print, digital 
• Motivate patients to 
talk with physician 
• Successful end-to-end 
study 
• 1 million test per 
year capacity
Highest prescribing 
primary care physicians 
Large networks 
employing large number 
of primary care physicians 
Source: Company estimates 
Target segmentation 
23
Who represents our initial target physician? 
98% Ob-Gyns 94% Internists 
• Orders 400 FIT or FOBT tests per year 
• Practices in a group setting without a GI 
• Female physicians, 15% more likely to recommend Cologuard 
24 
Family 
92% Practitioners 
Receptive to recommending Cologuard 
Source: Medspan research 2013; ZS Associates 2013 physician survey
Cologuard market research Physicians 
percent of FOBT/FIT tests that would be replaced 
with Cologuard by surveyed physicians 74% 
Source: Medspan research 2013; ZS Associates 2013 physician survey 
25 
percent of physicians likely to order Cologuard 
(67% very likely; 29% moderately likely) 96%
Cologuard market research Patients 
92% of patients likely to use Cologuard 
more patients likely to get screened 
through compliance program 2x 
26 
Sources: Medspan research; Epidemiol Rev 2011; 33(1):101-110 (Levin, T); Compliance in 
commercially insured Kaiser patients increased from 34% to 69% from 2004 to 2010.
Cologuard Sales team 
• 3 regions 
• 10 large 
system 
/hospital reps 
• 80 PCP reps 
• 10 area 
managers 
• 6 clinical 
27 
liaisons 
~10 years average health care sales experience
Cologuard Medical Education 2014 
Speakers Bureau 
• 100 opportunities through end of year 
• ~30 trained speakers, including GIs and PCPs 
Medical Conferences 
• Cleveland Clinic Digestive Diseases Nursing Symposium (Sept) 
• American College of Gastroenterologists (Oct) 
• American Association of Family Physicians (Oct) 
• Pri-Med Live & Online CME Meetings (Oct, Dec) 
28
29 
www.CologuardTest.com
Downloadable 
PDF can be 
brought to 
doctor’s office 
30
Cologuard Direct advertising 
• Full-page ad in Sunday New 
York Times after approval 
• 1.2 million impressions 
• Dramatic increase in clicks to 
www.CologuardTest.com 
through paid search 
31 
TALK TO YOUR DOCTOR ABOUT COLOGUARD. 
The breakthrough test for colon cancer screening that ’s as easy as going t o the bathroom, 
Cologuard is ef fect ive and easy to use in t he pr ivacy of your ow n ho m e—no sp ec ial 
preparat ion or t ime off w ork required. Only Cologuard uses innovat ive stool DNA technology 
t o fi nd 92%* of all colon cancers, and is completely noninvasive. 
Cologuard keeps screening between yo u—and your colon. 
Visit CologuardTest .com to learn more. 
Cologuard is int ended for the qualitat ive detect ion of colorectal neoplasia associated DNA markers and 
for the presence of occult hemoglobin in human stool. A posit ive result may indicate the presence of 
colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by a diagnost ic colonoscopy. 
Cologuard is indicated to screen adult s of either sex, 50 years or older, who are at t ypical average risk
Cologuard Direct advertising 
• Consumer news, heath care sites: New York Times, WebMD 
• Customized ad networks to reach target patient and physician profiles 
• Paid search to maximize consumer ability to find Cologuard 
32 
Digital 
campaign 
8 million 
impressions 
in first week
Cologuard Public relations 
Active effort to raise awareness of Cologuard 
• Cologuard featured in more than 360 unique news outlets 
• Outlets and sites reach more than 104 million unique readers 
33
Exact Sciences’ clinical laboratory 
Capacity: 1 million tests/year 
Customer service center 24/7 
30,000 square feet 
Highly automated 
34
35 Exact Sciences Lab
Cologuard workflow 
Physician 
orders test 
Kit 
shipped 
to patient 
Patient 
returns kit 
Exact lab 
processes 
sample 
Results 
sent to 
physician 
36
Digestive/GI cancers account for 25% of 580,000 U.S. 
cancer deaths 
2013 Estimated U.S. Cancer Deaths 
Other 
Lymphoma 
Leukemia 
Urinary 
Breast 
Genital 
GI 
145K 
Respiratory 
Source: American Cancer Society 2013, Surveillance Research 
37
GI cancer pipeline advancing 
in broad collaboration with Mayo Clinic 
Test Types Organ Focus 
Source: American Cancer Society 2013, Surveillance Research 
Screening 
Applied Diagnostics 
38 
Pancreas 
Esophagus 
Colorectal 
Stomach
Exact Sciences’ people: our most valuable asset 
Percent of engaged 
employees compared 
to benchmarks 
30% 
63% 
92% 
U.S. Average World-Class Organizations EXAS 2014 
39
Exact Sciences Summary 
• Cologuard® FDA-approved and launched with focused plan 
• 120-person sales force and growing 
• CMS proposes national coverage with 3-year testing interval 
• Mayo Clinic is first system to adopt Cologuard 
• Multibillion-dollar global opportunity 
• Cash balance of $235 million at 6/30/14 
40
Thank You

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Exact Sciences Company Presentation Baird Healthcare Conference

  • 1. Diagnostics for the early detection and prevention of colon cancer Corporate Presentation September 2014
  • 2. Safe Harbor Statement Certain statements made in this news release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. Forward-looking statements in this news release may address the following subjects among others: statements regarding the sufficiency of our capital resources, expectations concerning our ability to secure and the timing of reimbursement for our Cologuard test, our estimated reimbursement amounts, our estimates of the available market size and our potential penetration, expected research and development expenses, expected general and administrative expenses and our expectations concerning our business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. 1
  • 3. OUR MISSION To partner with healthcare providers, payers, patients and advocacy groups to help eradicate colorectal cancer 2
  • 4. Exact Sciences Overview Executing on the Mission • Cologuard® is an FDA-approved, breakthrough, non-invasive colorectal cancer screening test developed with Mayo Clinic • Uses a combination of DNA markers – Detects 92% of cancers • First time in history FDA approved a technology, CMS proposed national coverage on the same day – FDA approved on August 11, 2014 – CMS proposes 3-year interval in preliminary coverage decision • Multibillion-dollar global opportunity • 120-person sales force and growing 3
  • 6. 5 Cologuard FIT Improvement P Value Cancer detection 92% (60/65) 73% (48/65) 25% 0.002 Advanced Adenoma detection 42% (321/757) 24% (180/757) 78% <0.001 N Engl J Med 2014;370:1287-97. DOI: 10.1056/NEJMoa1311194 (Imperiale)
  • 7. Cologuard Indications for Use Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin human in stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at typical average-risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals. 6
  • 8. Center for Medicare & Medicaid Services Update 7 • 3-year interval proposed by CMS • Preliminary pricing expected late Aug or Sept • Final national coverage, pricing expected Q4 CMS
  • 9. Proposed Cologuard reimbursement crosswalk CologuardTM Crosswalk Proposed Payment 2 DNA methylation markers 8 81315 ML/RARalpha $282.83 7 DNA mutation markers 81275 KRAS $197.48 Fecal hemoglobin 82274 FIT $21.70 Total $502.01
  • 10. Mayo Clinic first system to adopt Cologuard • ~600 primary care physicians • 1.2 patients seen annually “…A critical step in beating this prevalent and preventable cancer.” - Vijay Shah, M.D., chair, gastroenterology & hepatology 9
  • 11. Stool DNA presently included in key cancer screening guidelines sDNA testing included in American Cancer Society screening guidelines in 2008 • Recommended for use by average-risk patients  Included in American College of Gastroenterology guidelines • 3-year interval for stool DNA  U.S. Preventative Services Task Force • 2015 update expected • If A/B rating, then all commercial payers must cover test 10
  • 12. Major opportunity to improve colorectal cancer screening The most preventable, yet least prevented cancer. – Journal of the National Cancer Institute Source: J Natl Cancer Inst. 2009; 101:1225-1227 (Itzkowitz) 11
  • 13. Detection and removal of polyps prevents cancer1 Pre-cancerous polyp Stages of colon cancer 10-15 years2 12 1Source: N Engl J Med 2012;366:687-96 (Zauber) 2Source Gastro 1997;112:594-692. (Winawer)
  • 14. Colorectal cancer: the second-leading U.S. cancer killer 136,830 Annual U.S. cancer mortality 14,270 29,480 39,590 40,430 50,310 159,260 4,020 Cervix Ovary Prostate Pancreas Breast Lung Source: ACS Cancer Facts & Figures 2014; all figures annual new U.S. cases 50,310 U.S. deaths Colorectal 13
  • 15. Late-stage detection leads to poor outcomes 60% of cancers are detected late stage Sources: CA Cancer J Clin 2008; 58:130-160 (Levin, B); ACS Colorectal Cancer Facts & Figures 2011-13; seer.cancer.gov/faststats 14
  • 16. Colorectal cancer costs significant and rising $14B annual treatment costs Source: J 15 Natl Cancer Inst. 2011; 103:1-12 (Mariotto)
  • 17. Low screening rate contributes to colorectal cancer deaths ~50% of Americans are current for recommended colonoscopy screening Source: 16 ACS Cancer Prevention & Early Detection Facts & Figures 2013
  • 18. American Cancer Society Goal: 80% by 2018 Colorectal Cervical 83% 65% Cancer screening rates 17 ACS Cancer Prevention & Early Detection Facts & Figures 2013; Company estimates
  • 19. Current U.S. screening of average-risk patients 10.2M fecal blood tests Source: CPT/HCPCS/ICD-9 Codes by Aileron Solutions; Company estimates 4.3M screening colonoscopies 14.5 million tests per year 55% FOBT FIT 45% 18
  • 20. Cologuard U.S. market opportunity 80M eligible for screening (>50 years old) Source: Company estimates >$2B Potential U.S. market 30% penetration 19
  • 21. Despite inadequacies, FIT rapidly gained market share over FOBT • Strategy of converting systems and high-volume users • Insignificant sales & marketing investment • Sensitivity advantages over FOBT • Without compliance engine 2% 45% 2004 2008 2012 20 Sources: Company estimates and CMS, Medicare Part B, Colorectal Cancer Screening
  • 22. Cologuard commercial strategy 21 Drive demand Provider • Physician & system outreach • Medical education • Publications Promote compliance Patient • Direct advertising • Public relations • Compliance engine Secure payment Payer • CMS parallel review • Managed care team
  • 23. Cologuard launch underway 22 Large sales team • 120 experienced sales leaders • Training complete Cutting-edge lab & support Targeted marketing • Strong program of PR, print, digital • Motivate patients to talk with physician • Successful end-to-end study • 1 million test per year capacity
  • 24. Highest prescribing primary care physicians Large networks employing large number of primary care physicians Source: Company estimates Target segmentation 23
  • 25. Who represents our initial target physician? 98% Ob-Gyns 94% Internists • Orders 400 FIT or FOBT tests per year • Practices in a group setting without a GI • Female physicians, 15% more likely to recommend Cologuard 24 Family 92% Practitioners Receptive to recommending Cologuard Source: Medspan research 2013; ZS Associates 2013 physician survey
  • 26. Cologuard market research Physicians percent of FOBT/FIT tests that would be replaced with Cologuard by surveyed physicians 74% Source: Medspan research 2013; ZS Associates 2013 physician survey 25 percent of physicians likely to order Cologuard (67% very likely; 29% moderately likely) 96%
  • 27. Cologuard market research Patients 92% of patients likely to use Cologuard more patients likely to get screened through compliance program 2x 26 Sources: Medspan research; Epidemiol Rev 2011; 33(1):101-110 (Levin, T); Compliance in commercially insured Kaiser patients increased from 34% to 69% from 2004 to 2010.
  • 28. Cologuard Sales team • 3 regions • 10 large system /hospital reps • 80 PCP reps • 10 area managers • 6 clinical 27 liaisons ~10 years average health care sales experience
  • 29. Cologuard Medical Education 2014 Speakers Bureau • 100 opportunities through end of year • ~30 trained speakers, including GIs and PCPs Medical Conferences • Cleveland Clinic Digestive Diseases Nursing Symposium (Sept) • American College of Gastroenterologists (Oct) • American Association of Family Physicians (Oct) • Pri-Med Live & Online CME Meetings (Oct, Dec) 28
  • 31. Downloadable PDF can be brought to doctor’s office 30
  • 32. Cologuard Direct advertising • Full-page ad in Sunday New York Times after approval • 1.2 million impressions • Dramatic increase in clicks to www.CologuardTest.com through paid search 31 TALK TO YOUR DOCTOR ABOUT COLOGUARD. The breakthrough test for colon cancer screening that ’s as easy as going t o the bathroom, Cologuard is ef fect ive and easy to use in t he pr ivacy of your ow n ho m e—no sp ec ial preparat ion or t ime off w ork required. Only Cologuard uses innovat ive stool DNA technology t o fi nd 92%* of all colon cancers, and is completely noninvasive. Cologuard keeps screening between yo u—and your colon. Visit CologuardTest .com to learn more. Cologuard is int ended for the qualitat ive detect ion of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A posit ive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by a diagnost ic colonoscopy. Cologuard is indicated to screen adult s of either sex, 50 years or older, who are at t ypical average risk
  • 33. Cologuard Direct advertising • Consumer news, heath care sites: New York Times, WebMD • Customized ad networks to reach target patient and physician profiles • Paid search to maximize consumer ability to find Cologuard 32 Digital campaign 8 million impressions in first week
  • 34. Cologuard Public relations Active effort to raise awareness of Cologuard • Cologuard featured in more than 360 unique news outlets • Outlets and sites reach more than 104 million unique readers 33
  • 35. Exact Sciences’ clinical laboratory Capacity: 1 million tests/year Customer service center 24/7 30,000 square feet Highly automated 34
  • 37. Cologuard workflow Physician orders test Kit shipped to patient Patient returns kit Exact lab processes sample Results sent to physician 36
  • 38. Digestive/GI cancers account for 25% of 580,000 U.S. cancer deaths 2013 Estimated U.S. Cancer Deaths Other Lymphoma Leukemia Urinary Breast Genital GI 145K Respiratory Source: American Cancer Society 2013, Surveillance Research 37
  • 39. GI cancer pipeline advancing in broad collaboration with Mayo Clinic Test Types Organ Focus Source: American Cancer Society 2013, Surveillance Research Screening Applied Diagnostics 38 Pancreas Esophagus Colorectal Stomach
  • 40. Exact Sciences’ people: our most valuable asset Percent of engaged employees compared to benchmarks 30% 63% 92% U.S. Average World-Class Organizations EXAS 2014 39
  • 41. Exact Sciences Summary • Cologuard® FDA-approved and launched with focused plan • 120-person sales force and growing • CMS proposes national coverage with 3-year testing interval • Mayo Clinic is first system to adopt Cologuard • Multibillion-dollar global opportunity • Cash balance of $235 million at 6/30/14 40

Notes de l'éditeur

  1. Cologuard – here it is.
  2. The point sensitivity of Cologuard for the detection of colorectal cancer was 92.3 percent compared with 73.8 percent for FIT. This is a difference of 18.5 percentage points and is statistically significant. The point sensitivity of Cologuard for advanced adenomas was 42.4 compared with 23.8 percent for FIT. This is a difference of 18.6 percentage points and is again statistically significant. The isolated performance of the hemoglobin immunoassay component of Cologuard was similar to that of FIT, with sensitivities of 72.3 percent and 73.8 percent, respectively, for the detection of colorectal cancer, and 22.7 percent and 23.8 percent, respectively, for the detection of advanced pre-cancerous lesions. The specificities were 94.8 percent and 94.9 percent, respectively. Cologuard also outperformed FIT in hypothetical screening of 10,000 patients. (Next slide…)
  3. Most diagnostic tests have a code that corresponds to a reimbursement rate. When a code doesn’t exist for a new test like Cologuard, a new code can be crosswalked or linked to existing codes to establish payment for the new test. We were asked by CMS to use the crosswalk approach. We were invited to present our crosswalk reimbursement proposal to CMS’ Hospital & Ambulatory Policy Group or HAPG at its annual reimbursement review last week. Our crosswalk proposal is based on codes in the 2014 Clinical Laboratory Fee Schedule. Shown here are the three Tier 1 codes that we presented in our crosswalk. These include a code that corresponds directly to our KRAS mutation markers and another that corresponds directly to our fecal hemoglobin test. Our DNA methylation markers are crosswalked to an RNA assay with a workflow similar to ours. These codes total to a proposed reimbursement for Cologuard of 502 dollars. CMS does not provide feedback on proposals at these meetings. The next step is a preliminary pricing decision from HAPG by early September, followed by a public comment period and a final decision in November. Taken together, the reimbursement and regulatory timeline looks like this… (Next slide…)
  4. Annual
  5. So imagine what we can do with Cologuard
  6. This is the first time we’re publicly sharing these survey data publicly.
  7. Where does 3.5x figure come from
  8. We have developed a technology platform that is applicable to the screening and diagnosis of other cancers. We intend to develop novel, clinically important diagnostic screening tests for GI tract cancers. We have a broad, exclusive collaboration with Mayo Clinic on GI tract cancers. The collaboration is unique and, together, we’re developing two new kinds of tests. As a reminder, GI cancers comprise 25 percent of all cancer deaths in the United States. First, we’re working together on tests that can screen general, asymptomatic populations for pre-cancers and cancer across the entire GI tract. Second, we’re developing new applied diagnostic tests for specific gastrointestinal cancers that would potentially be used with high-risk and symptomatic patients. Within those two general kinds of tests, we’re focusing on colorectal, pancreatic, esophageal and stomach cancers. At Digestive Disease Week in May, some very interesting data was presented that resulted from our collaboration. Our technology platform demonstrated 88percent sensitivity for pancreatic cancer by testing pancreatic juice for certain DNA mutations and methylations. The technology also demonstrated 100% sensitivity for detecting Barrett’s esophagus, the precursor to the vast majority of esophageal cancer. We are continuing to make progress with our pipeline and look forward to updating you by early next year. In conclusion… (Next slide…)