Testing for Colorectal Cancer Has Been Anything but Routine Until Now.

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Julian George
6 years ago
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TM Testing for Colorectal Cancer Has Been Anything but Routine Until Now. Compliance rates for recommended colorectal cancer testing are dismal.

1 TM Testing for Colorectal Cancer Has Been Anything but Routine Until Now. Compliance rates for recommended colorectal cancer testing are dismal. The SimpliPro Colon test is a laboratory service designed to reverse that trend with a noninvasive blood test service that measures specific protein markers and fits seamlessly into routine patient workups for those with an elevated risk* for colorectal cancer.

2 The Best Test is the One That Gets Done %2 Compliance reported with blood test Better Colorectal Cancer Testing Compliance Results in Early Detection 62%3 Colonoscopy compliance 28%4 Fecal test compliance 90%5 5-year survival rate, if detected early 13%5 5-year survival rate, if detected in late stages *Elevated-risk patients are defined as those who presented with the symptoms observed in the SimpliPro Colon test studies.

Introducing the SimpliPro Colon Test The SimpliPro Colon test is a laboratory service available only to healthcare providers to enable better compliance for diagnostic colonoscopy for patients

3 Introducing the SimpliPro Colon Test The SimpliPro Colon test is a laboratory service available only to healthcare providers to enable better compliance for diagnostic colonoscopy for patients presenting with symptoms associated with colorectal cancer. It is a blood-based test that measures and analyzes 11 protein markers associated with a risk of colorectal cancer. As a group, these proteins have been found to correlate with a higher or lower risk of positive diagnosis of colorectal cancer and/or advanced adenoma using Its unique combination of convenience and performance makes the SimpliPro Colon test ideal for helping to drive greater compliance for colonoscopy. Making Compliance the New Routine The SimpliPro Colon test requires only a blood draw and can be performed in your office or lab. There are no new procedures for you and your staff to learn. There is no handling of feces or waiting for at-home tests to be returned. Seamless Integration The SimpliPro Colon test is administered like other blood tests, fitting ideally into your practice s routine. Increased Compliance The SimpliPro Colon test may help increase compliance for colonoscopy among your elevated-risk patients.

Ideal For Elevated-Risk Patients * There are many risk factors associated with colorectal cancer and its symptoms can take various forms.

stool, including diarrhea or constipation Abdominal discomfort such as cramps, gas, or pain Blood in stool Rectal bleeding Distension of the abdomen

The SimpliPro Colon test is developed and is offered by Applied Proteomics, Inc.

4 Ideal For Elevated-Risk Patients * There are many risk factors associated with colorectal cancer and its symptoms can take various forms. The symptoms associated with subjects in the development studies included: Unexplained weight loss Anemia Change in bowel habits or consistency of stool, including diarrhea or constipation Abdominal discomfort such as cramps, gas, or pain Blood in stool Rectal bleeding Distension of the abdomen Palpable mass The SimpliPro Colon test is not intended for use as a screening test or for asymptomatic patients. The SimpliPro Colon test is developed and is offered by Applied Proteomics, Inc., in its Clinical Laboratory Improvement Amendments (CLIA) certified and the College of American Pathologists (CAP) accredited laboratory in San Diego, CA. *Elevated-risk patients are defined as those who presented with the symptoms observed in the SimpliPro Colon test studies.

5 Test Attributes + Convenience = The Ideal Choice for Noninvasive Colorectal Cancer Testing Test Attributes Colorectal Cancer Advanced Adenoma 81%6 sensitivity in all stages of colorectal cancer (stages I-IV) 6 75% sensitivity in early stages of colorectal cancer (stages I-II) 6 88% sensitivity in late stages of colorectal cancer (stages III-IV) 78%6 45%6 80%6 specificity sensitivity specificity 1,6056 Patients included across multiple studies in the development of the SimpliPro Colon test.* + + = Seamless Integration Higher Compliance Early Detection through Diagnostic Colonoscopy Lower Mortality * A total of 1,605 patients were included in the development of the SimpliPro Colon test for colorectal cancer and advanced adenoma. 1,347 patients were studied for colorectal cancer only.

6 Actionable Insights Made Clear The SimpliPro Colon test results are delivered in a concise, easy-to-read report. Separate results that indicate a higher or lower risk of positive diagnosis of colorectal cancer and advanced adenoma using Applied Proteomics, Inc John Hopkins Court, Suite 150 San Diego, CA Customer Care SIMPLI ( ) Customer Care Fax LAB ( ) customercare@simpliprocolon.com Test Results Report The CAP # SimpliPro CLIA #05D Colon Test Risk Result for Patient & Practice Information Colorectal Cancer Patient Name Date of Birth (mm/dd/yyyy) Sex Medical Record/Patient Number Practice Name Ordering Physician Ordering Physician Fax The SimpliPro Colon Test Risk Result for Colorectal Cancer HIGHER A higher test result indicates a 2.8 fold increase (or a 31% probability) of a positive diagnosis of colorectal cancer, based on a clinical study of symptomatic patients referred for The SimpliPro Colon Test Risk Result for Advanced Adenoma LOWER A lower test result indicates a 1.4 fold decrease (or a 5.2% probability) of a positive diagnosis of advanced adenoma, based on a clinical study of symptomatic patients referred for Comments SimpliPro Colon Order Number Sample Collected Sample Received Sample Reported About This Test: The SimpliPro Colon test is a clinical laboratory service available only to healthcare providers for determining the risk of colorectal cancer or advanced adenoma. Results of the SimpliPro Colon test are intended to predict the likelihood of the presence of colorectal cancer or advanced adenoma, based on a study of symptomatic patients referred for diagnostic colonoscopy, and should not be used alone to determine a positive diagnosis. The test is for adjunctive use in addition to the clinical examination by a physician to aid in determining the need for a Results of the SimpliPro Colon test were validated in symptomatic patients referred for diagnostic colonoscopy and may not correlate with the percent probability determined in asymptomatic patients. Methodology: The SimpliPro Colon test uses a blood sample to test for and measure eleven proteins that have been shown in clinical studies, that when analyzed as a group, correlate with a higher or lower risk of positive diagnosis of colorectal cancer and/or advanced adenoma using The SimpliPro Colon test is performed utilizing enzymelinked immunosorbent assays (ELISA) to test for and measure the levels of the eleven proteins and utilizes a proprietary algorithm to combine the individual protein levels into a single result that is presented as a risk percentage to indicate the likelihood that patients will test positive for colorectal cancer or advanced adenoma by Based on a clinical study of symptomatic patients, the baseline risk for the presence of colorectal cancer or advanced adenoma was 10.9% and 7.4% respectively (confirmed by colonoscopy with biopsy of endoscopic lesions). Symptoms associated with the subjects in these studies included palpable mass, anemia, change in bowel habits, bleeding, weight loss, distension of the abdomen and pain. M F HIGHER A higher test result indicates a 2.8 fold increase (or a 31% probability) of a positive diagnosis of colorectal cancer, based on a clinical study of symptomatic patients referred for The SimpliPro Colon Test Risk Result for Advanced Adenoma LOWER A lower test result indicates a 1.4 fold decrease (or a 5.2% probability) of a positive diagnosis of advanced adenoma, based on a clinical study of symptomatic patients referred for Lab Director: Richard E. Safrin, MD Approval Signature Date SimpliPro Colon is a laboratory developed test developed by Applied Proteomics, Inc. (API). The performance characteristics of the test were determined by API in its San Diego, CA, clinical laboratory that is regulated by the Clinical Laboratory Improvements Amendments of 1988 (CLIA). The laboratory has been certified under the CLIA to perform high-complexity clinical testing and is also accredited by the College of American Pathologists (CAP). This test is used for clinical purposes and should not be regarded as investigational or for research. The SimpliPro Colon mark, the SimpliPro Colon logo, and the Applied Proteomics logo are trademarks of Applied Proteomics, Inc. Copyright Applied Proteomics, Inc. All rights reserved. API1-FRM-QA-0022v02

TM Here for You and Your Patients From Start to Finish Our Customer Care team is standing by to provide everything you need to administer the SimpliPro Colon test, coordinate shipping to our CLIA

The SimpliPro Colon Test Process FAX 1 2 3 4 5 Patient arrives fasted for blood work Utilizing the provided phlebotomy tools, draw the patient s blood Following the instructions for use provided,

7 TM Here for You and Your Patients From Start to Finish Our Customer Care team is standing by to provide everything you need to administer the SimpliPro Colon test, coordinate shipping to our CLIA lab, and process billing and insurance claims. The SimpliPro Colon Test Process FAX Patient arrives fasted for blood work Utilizing the provided phlebotomy tools, draw the patient s blood Following the instructions for use provided, prepare the sample and package for shipping The patient s sample is analyzed via enzyme-linked immunosorbent assays (ELISA) at Applied Proteomics CLIA- certified and CAPaccredited lab Within 7-10 business days, the patient test report will be faxed to your office Billing Made Simple Applied Proteomics will Bill all private insurance and Medicare on your patients behalf Directly bill cash-paying patients Bill all applicable co-pays and deductibles Applied Proteomics, the makers of the SimpliPro Colon test, offer CarePRO, a financial assistance program that aligns with the federal poverty guidelines to assist patients who may qualify. Please contact Customer Care for more information at SIMPLI ( ).

8 The SimpliPro Colon Test Making Compliance the New Routine. The SimpliPro Colon Test Requirements Patient to fast for at least eight hours prior to blood draw. Centrifugation of sample. Samples to be shipped to our CLIA lab on dry ice. If your office does not currently have access to dry ice, please call SIMPLI ( ), and we will assist you. For more information or to learn how to order, contact: 3545 John Hopkins Court, Suite 150 San Diego, CA Customer Care SIMPLI ( ) Customer Care Fax LAB ( ) TM CAP # CLIA #05D References: 1. Gupta, Samir, et al. Challenges and possible solutions to colorectal cancer screening for the underserved. J Natl Cancer Inst Apr ;106(4):dju032. doi: /jnci/dju032. Epub 2014 Mar Epigenomics, Inc. Adherence to Minimally Invasive Testing (ADMIT). In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US) [29 June 2015]. Available from clinicaltrials.gov/ct2/show/nct (CDC) CfDCaP. Behavioral risk factor surveillance system survey data. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, Levi Z, Birkenfeld S, Bilkin A, et al. A higher detection rate for colorectal cancer and advanced adenomatous polyp for screening with immunochemical fecal occult blood test than guaiac fecal occult blood test, despite lower compliance rate. A prospective, controlled, feasibility study. Int J Cancer May 15 ;128(10): doi: /ijc SEER Cancer Center. Cancer Statistics Review , Table 6.12: Cancer of the Colon and Rectum (Invasive). html#table5sect_06_table.12.pdf. 6. Applied Proteomics, Inc. data on file. The SimpliPro Colon mark, the SimpliPro Colon logo, the CarePRO mark and the Applied Proteomics logo are trademarks of Applied Proteomics, Inc. Copyright Applied Proteomics, Inc. All rights reserved. API1-FRM-MKT-005v03

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who where symptoms? colon cancer facts affected? what who Over 130,000 new cases diagnosed each year is Greater than 50,000 deaths annually attributable to colon cancer Second leading cause of cancer death in the U.S. Equal risk in men and women Women over