is epi procolon® right for you? - amazon web services · epi pro colon is the first and only fda...

Epi proColon® is an FDA-approved blood test for colorectal cancer screening for average-risk persons, age 50 and older who are unwilling or unable to be screened by other recommended methods (imaging and/or stools tests). Epi proColon® is a registered trademark of Epigenomics AG, in Europe, USA and/or other selected countries. MKT0054 Rev1 ©2016 Epigenomics, Inc. USA Is Epi proColon® Right for You? Epi pro Colon is the FIRST and ONLY FDA approved blood test for colorectal cancer screening Epi proColon is intended for the average risk pa�ent who is unable or unwilling to be screened by tradi�onal CRC screening methods (colonoscopy or stool tests). T o determine if Epi proColon is right for you, discuss the following with your doctor: ___ yes ___ no Are you considered average risk for colorectal cancer? ___ yes ___ no Have you avoided colorectal cancer screening? Epi proColon detects as many cancers as FIT with the convenience of a blood test What is the science behind Epi proColon? • Epi proColon detects methylated Sep�n 9 DNA that has been shed into the bloodstream from throughout the colon and rectum. 1 • Methyla�on of the SEPT9 gene is increased in colorectal cancer . 1 Where do my pa�ents get tested? A rou�ne blood draw can be performed in your oﬃce or at a par�cipa�ng regional or na�onal clinical laborator y (LabCorp, ARUP) as designated by the pa�ent’s healthcare plan. How do I interpret the Epi proColon Result? If Epi proColon is posi�ve, refer your patient for a diagnos�c colonoscopy. If Epi proColon is nega�ve, discuss a future screening plan that is right for your pa�ent. Where can I get more informa�on about Epi proColon? www.EpiproColon.com 844 537 4669 (844 5 EPI NOW) 1 Epi proColon Instruc�ons for Use, IFU 0008 and data on ﬁle. 2 Po�er N et. al. Valida�on of a Real-Time PCR-based qualita�ve assay for the detec�on of methylated SEPT9 DNA in human plasma. Clin Chem. 2014, 60(9):1183-1191. 3 Johnson D et al. Plasma Sep�n9 versus fecal immunochemical tes�ng for colorectal cancer screening: a prospec�ve mul�center study. PLOS ONE. 2014, 9(6):1-8. E98238. N= 290 Sens % Spec % NPV % EPC 72.2 80.8 99.8 FIT (OC-Auto) 68.0 97.4 99.8 Compared the accuracy of Epi proColon to a Fecal Immunochemical Test (FIT) using matched blood and stool samples from 290 people. N= 1,544 Sens % Spec % NPV % EPC 68.2 80.0 99.7 Compared the accuracy of Epi proColon to colonoscopy in 1,544 plasma samples from people, age 50-85 years of age who were of average-risk for CRC. Epi proColon Total A d h e r e n t 202 N o n - A d h e r e n t 1 T o t a l 203 E P C A d h e r e n c e R a t e 99.5% A d h e r e n c e S t u d y C o m p a r i s o n t o C o l o n o s c o p y C o m p a r i s o n t o F I T 1 2 3 Rx Only Technical Information for Healthcare Professional

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Page 1: Is Epi proColon® Right for You? - Amazon Web Services · Epi pro Colon is the FIRST and ONLY FDA approved blood test for colorectal cancer screening Epi proColon is intended for

Is Epi proColon® Right for You?Epi pro Colon is the FIRST and ONLY FDA approved blood test for colorectal cancer screening

Epi proColon is intended for the average risk pa�ent who is unable or unwilling to be screened by tradi�onal CRC screening methods (colonoscopy or stool tests).

To determine if Epi proColon is right for you, discuss the following with your doctor:___ yes ___ no Are you considered average risk for colorectal cancer?___ yes ___ no Have you avoided colorectal cancer screening?

Epi proColon detects as many cancers as FIT with the convenience of a blood test

What is the science behind Epi proColon?• Epi proColon detects methylated Sep�n 9 DNA that has been shed into the bloodstream from

throughout the colon and rectum.1

• Methyla�on of the SEPT9 gene is increased in colorectal cancer.1

Where do my pa�ents get tested?A rou�ne blood draw can be performed in your office or at a par�cipa�ng regional or na�onal clinical laboratory (LabCorp, ARUP) as designated by the pa�ent’s healthcare plan.

How do I interpret the Epi proColon Result?If Epi proColon is posi�ve, refer your patient for a diagnos�c colonoscopy.If Epi proColon is nega�ve, discuss a future screening plan that is right for your pa�ent.

Where can I get more informa�on about Epi proColon?www.EpiproColon.com 844 537 4669 (844 5 EPI NOW)

1 Epi proColon Instruc�ons for Use, IFU 0008 and data on file.2 Po�er N et. al. Valida�on of a Real-Time PCR-based qualita�ve assay for the detec�on of methylated SEPT9 DNA in human plasma. Clin Chem. 2014, 60(9):1183-1191.3 Johnson D et al. Plasma Sep�n9 versus fecal immunochemical tes�ng for colorectal cancer screening: a prospec�ve mul�center study. PLOS ONE. 2014, 9(6):1-8. E98238.

N= 290 Sens % Spec % NPV %

EPC 72.2 80.8 99.8

FIT (OC-Auto) 68.0 97.4 99.8

Compared the accuracy of Epi proColon to a Fecal Immunochemical Test (FIT) using matched blood

and stool samples from 290 people.

N= 1,544 Sens % Spec % NPV %

EPC 68.2 80.0 99.7

Compared the accuracy of Epi proColon to colonoscopy in 1,544 plasma samples from people, age 50-85 years of age who were of

average-risk for CRC.

Epi proColon

Total

Adherent 202