A TEST FOR COLORECTAL CANCER THAT IS 92% SENSITIVE AND NON-INVASIVE. Stool DNA test

Transcription

1 A TEST FOR COLORECTAL CANCER THAT IS 92% SENSITIVE AND NON-INVASIVE Stool DNA test

2 THE NEW NON-INVASIVE SCREENING TEST FOR COLORECTAL CANCER Sensitive Clinically proven 1 Easy to use FDA approved

3 COLOGUARD THE FIRST CHOICE NON-INVASIVE TEST FOR COLORECTAL CANCER SCREENING PROXIMAL In a prospective, head-to-head, point-in-time, 90 site, pivotal study of 10,000 patients, published in the New England Journal of Medicine 1 92% SENSITIVITY IN DETECTING COLORECTAL CANCERS, STAGES I-IV *1 94% SENSITIVITY IN DETECTING COLORECTAL CANCERS, EARLY STAGES I-II *1 87% SPECIFICITY OVERALL, INCLUDING ALL NONADVANCED ADENOMA 1 CONSISTENT DETECTION OF BOTH LEFT-SIDED AND RIGHT-SIDED CANCERS 1 DISTAL SIGNIFICANTLY IMPROVED SENSITIVITY OVER A LEADING FECAL IMMUNOCHEMICAL BLOOD TEST FOR DETECTING CANCER AND PRECANCER 1 DETECTS 78% MORE ADVANCED PRE-CANCEROUS LESIONS COMPARED TO THE FIT TEST 1 TO DETECT ONE CANCER, CLINICIANS USING COLOGUARD WOULD NEED TO SCREEN 20% FEWER PATIENTS COMPARED TO USING THE FIT TEST 1 *Cologuard sensitivity, per stage of cancer: I: 90% (n=29); II: 100% (n=21); III: 90% (n=10); IV: 75% (n=4). OC FIT-CHEK, Polymedco, Inc.; sensitivity: 74%, specificity: 95%. DETECTS POLYPS Advanced adenomas often protrude into the colon in the shape of a mushroom. DETECTS FLAT LESIONS (SESSILE SERRATED POLYPS) Often likely to be cancerous, flat lesions are also usually more difficult to find. 2

4 COLOGUARD - the science of early detection COLOGUARD S multiple marker sdna technology Cutting-edge stool DNA (sdna) technology for cancer and precancer detection means more curable-stage cancers can be found. 11 Distinct molecular markers identify precancerous cells and cancer 7 DNA mutation markers 2 DNA methylation markers 1 Haemoglobin marker COLOGUARD FAECAL BLOOD TESTS 1 Beta actin control SINGLE TEST RESULT Detects DNA from cells and haemoglobin Cells constantly shed into stool which leads to consistent results 11 markers VS Only detects blood in stool Polyps or lesions bleed intermittently which leads to inconsistent results 1 1 marker

5 COLOGUARD collection kit components COLOGUARD our contact details The Cologuard Collection Kit is easy to use in the privacy of the patient s home. For further enqiries please contact: What s inside the Cologuard Collection Kit: BRACKET SHIPPING BOX SAMPLE CONTAINER HB SAMPLER Sarah Field Regional Marketing Manager, Europe Mobile: +44 (0) sfield@exactsciences.com BUFFER SOLUTION SAMPLE LABELS

6 COLOGUARD : INNOVATIVE STOOL DNA TECHNOLOGY Make Cologuard your first choice non-invasive test for colorectal cancer screening. 92% Sensitivity/87% specificity*: Detects all stages of colorectal cancer (stages I-IV) 1 Easy for patients: Non-invasive easy to use at home sample collection Clinically proven and FDA approved: A prospective, head-to-head, point-in-time, 90 site, pivotal study of 10,000 patients published in the New England Journal of Medicine 1 supported approval Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult haemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and patients with this result should be triaged for further investigation. Cologuard is indicated for adults that are at typical risk for CRC, of either sex and who are 50 years of age or older. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals. *Excluding colorectal cancer and advanced adenomas. PB GBR-EN (Adapted from CG ) REFERENCES: 1. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(4): Noffsinger AE. Serrated polyps and colorectal cancer: new pathway to malignancy. Annu Rev Pathol. 2009;4: EXACT SCIENCES C ORPORATION 441 Charmany Drive, Madison, WI Cologuard is a registered trademark of Exact Sciences Corporation Exact Sciences Corporation. All rights reserved.