DCA Vantage Product Guide 2009

Product Guide

62 Pages

Table of Contents Page 2  Introduction 3  Overview: DCA Vantage 5  HbA1c Test 10  DCA HbA1c Fact Sheets 27  Chronic Kidney Disease 35  Microalbumin/Creatinine 36  DCA Microalbumin/Creatinine Fact Sheets 56 08/11/09 Protection notice / © 2009 Siemens Healthcare Diagnostics Inc. Siemens Healthcare Diagnostics / US Marketing

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Page 1

Answers for life.

DCA Vantage Product Guide - 2009

Table of Contents

Page 2

 Introduction

 Overview: DCA Vantage

 HbA1c Test

 DCA HbA1c Fact Sheets

 Chronic Kidney Disease

 Microalbumin/Creatinine

 DCA Microalbumin/Creatinine Fact Sheets

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What is the DCA Vantage System? The DCA Vantage Analyzer is a point-ofcare immunoassay analyzer for diabetes management for use in the physician office or lab, diabetes care clinic, or POC coordinated site. It provides quantitative test results for HbA1c in whole blood during the patient visit to help improve decision making. With a single urine sample, the analyzer also provides quantitative test results for low levels of Albumin, Creatinine and A:C Ratio in the physician office or clinic.

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DCA Tests – Clinical Use

HbA1c is used to monitor the treatment of patients with Diabetes

Microalbumin is used to determine the onset of Kidney Disease Creatinine and the Ratio are used to correct the albumin result for variances due to urine concentration

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DCA Vantage Overview

 30-Second Hands-On Procedure  Error Resistant Procedure  On Board Printer  Patient/Operator ID  QC Lockout  Download Data to Flash Drive  Flexible Data Search  Many References  User Prompted Touch Screen  Robust Data Mgmt Options  4,000 Result Memory  Patient Trend Graphing  User Access Restrictions

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DCA Vantage … A Flexible System Features for any Testing Environment Satellite Clinic

Hospital

Diabetes Clinic

POC

Satellite Clinic

Coordinator

Affiliated Physicians

Satellite Clinic

Physicians’ Offices

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Diabetes Care Centers/ Clinics

Group

DCA Vantage…A Flexible System Examples of DCA Vantage Features which can be Activated

Run Test Print Results

Run Test

Patient ID

Print Result

Run Test Patient ID

Run Test Patient ID Operator ID

Operator ID Patient Info Print Result

Print Results

Recall Data Data to PC

Run Test Patient ID

Operator ID QC Reminders Results to LIS

Run Test Patient ID Operator ID

QC Lockout

User Restrictions Remote Access Results to LIS

Add Sample Enter Data Load Cartridge Print/Upload Results Recall Data

Add Sample Load Cartridge Print Result

DCA Customization: Customers Choose which Features to Activate Based on Their Needs Page 7

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DCA Vantage History…An Impressive Pedigree Now, over 20,000 DCA 2000/Vantage units installed in US

HbA1c Microalbumin /creatinine

1995

1990

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2000

2005

2010

DCA Vantage Sales Since Introduction Impressive Market-Leading Position Greater than 70% of all POC HbA1c testing is performed on a DCA System* 4 out of 5 physicians performing in-office HbA1C testing use the DCA Vantage analyzer* Your Peers in FY 2009 DSS Monthly Average: 16 Sales/Placements Top reps are averaging over 27 DCA Vantage sales per month What Will You Do To Attain These Levels? Sources: GHX Q2 2009 Marketing Data

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Section 1: HbA1c Test

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What is HbA1c?  Glucose molecules in the blood stream attach to the hemoglobin molecule in an irreversible bond  Most of the attached glucose is to what is called the HbA1c sub-fraction of the hemoglobin molecule  The greater the amount of glucose available in the blood, the higher the percent will be bound to HbA1c (this is why HbA1c is reported in %)  Therefore, HbA1c is the reference value most often used in measuring glycemic control (i.e. the average blood glucose level over time) Sources: Health Devices 2003, 32:435; ADA technical review, Tests of Glycemia in Diabetes, 2004; Manley S., Clin Chem Lab Med 2003, 41:1182-90

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HbA1c Testing – Represents a “Trend” Over Time  HbA1c is reported in percent (%) and represents the average blood glucose level over a 60-90 day period.  The majority of Red Blood Cells (RBC) will be 60-90 days old at any given point in time based on the lifespan of a RBC. This is why HbA1c represents an average blood glucose for the past 60-90 days.  HbA1c levels are the primary target goal for glycemic control, with the goal being < 7.0%1,2  Outcome studies have clearly shown A1c to be the primary predictor of complications due to Diabetes1  Perform the A1c test at least 2 times a year in patients who are meeting goals or quarterly in patients whose therapy has changed or are not meeting goals3 Sources: Health Devices 2003, 32:435; ADA technical review, Tests of Glycemia in Diabetes, 2004; Manley S., Clin Chem Lab Med 2003, 41:1182-90 1”Standards of Medical Care in Diabetes – 2009, Diabetes Care, Volume 32, Supplement 1, January 2009, pg S22 2Some physicians may choose the HbA1c target to be less than 7.0% depending on the type of diabetic patient and the goal of the physician 3Executive Summary: Standards of Medical Care in Diabetes – 2009, Diabetes Care, Volume 32, Supplement 1, January 2009, pg S7

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Importance of HbA1c Testing “An international expert committee has recommended a new way of diagnosing whether someone has diabetes…Currently, most people are diagnosed via fasting glucose tests or oral glucose tolerance tests. But these tests offer only a snapshot of glucose levels on a particular day, a number that can by swayed by exercise, illness, or even the temperature of the room in which the blood sample is housed. That’s why the panel is recommending a switch to the A1c test for diagnosing diabetes. The committee is made up of representatives of the American Diabetes Association, the International Diabetes Federation, and the European Association for the Study of Diabetes”* For more information on HbA1C testing visit the American Diabetes Association’s website at www.diabetes.org *As of August 12, 2009, the A1c test is not an FDA-approved method for diagnosing Diabetes Sources: American Diabetes Association, Diabetes Forecast Magazine, http://forecast.diabetes.org/magazine/forecast/a1c-testdiagnosis Page 13

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Relationship of HbA1c to Estimated Average Blood Glucose (eAG) The trend is to compare hemoglobin A1c results to an estimated average blood glucose level to make it easier for the patient to understand 

Production of HbA1c is directly related to glucose concentration in blood



More glucose in the blood results in higher HbA1c levels



Blood glucose levels from the preceding 30 days determine about 50% of the total HbA1c Now available on POD- Part number A91DX-0701136-UC2-4A00

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Importance of HbA1c Testing Diabetes Control and Complications Trial (DCCT):  Improved glycemic control is associated with sustained decreased rates of eye, nerve, and kidney disease complications  A goal of HbA1c < 7.0% can result in a 50 to 75% reduction in risk for developing complications United Kingdom Prospective Diabetes Study (UKPDS)  Significant reduction in risk of complications when HbA1c is kept below 8%  For every 1% decrease in HbA1c, the risk of developing complications is decreased by 35%

Sources: ADA technical review, Tests of Glycemia in Diabetes, 2004; Bode, BW (Ed.), Medical Management of Type 1 Diabetes; UKPDS website www.dtu.ox.ac.uk/index.html?maindoc=/ukpds/ ; DCCT

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Diabetes Statistics  23.6 mm people in the US, or 8% of the total population live with Diabetes  There has been a 13.5% increase in Diabetes cases from 2005-2007  25% of those affected are unaware that they have Diabetes  The total annual economic cost of diabetes in 2007 was estimated to be $174 billion; medical expenditures totaled $116 billion  If left untreated, Diabetes can lead to serious complications, such as blindness, kidney damage, cardiovascular disease, and lower-limb amputations

Diabetes care- $27 billion Chronic diabetes related complications- 58 billion Excess general medical costs- $31 billion

Sources: American Diabetes Association; Diabetes Pro: Professional Resources Online; Department of Health and Human Services; Centers for Disease Control and Prevention Protection notice / © 2009 Siemens Healthcare Diagnostics Inc. 08/11/09 Page 16 Siemens Healthcare Diagnostics / US Marketing

Why DCA Vantage for HbA1c?

Trust and Quality Sample and Reagent Handling

Data Mgmt

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User Interface

Why DCA Vantage for HbA1c? Trust & Quality  > 100 peer-reviewed articles provides extensive reference list  4 out of 5 POC customers performing HbA1c use the DCA System  NGSP-certified results meet guidelines User Interface  Intuitive, self-prompting, touch screen supports ease of use and training  QWERTY keyboard eases ID entry and reduces chance of errors  Patient trend graphs provide immediate feedback on success of patient treatment  QC lock-out assures that guidelines are followed Page 18

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Why DCA Vantage for HbA1c? Reliability  Lab quality results meet standards of care  Low reagent failure rate saves time and money Data Management  4000 test memory provides the ability to recall test results  Extensive data search capabilities make it easy to find results in the memory  Flexible connectivity options for EMR/LIS, allow customers to download results to their systems  USB port for downloading data to a flash drive Sample and Reagent Handling  Long shelf life; can be stored at room temperature for up to 3 months  Extra capillary holders for repeat sampling saves money  Minimal handling requirements save time and reduce testing errors Page 19

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GHX Report HbA1c Reagent Market Share by Dollars 2008 Hemoglobin A1C Market Share by Reagent Revenue Distribution Market GHX Q4 2008

15.5%

0.0%

1.9% 0.1%

82.5%

0.0%

Siemens

Metrika

Cholestech

Polymedco

Other

 Siemens has an 82.5% Market Share in the Distribution Market  Siemens has gained 4.5 points in market share since Q4 2007  Metrika’s market share has fallen 4.2 points from 19.7% to 15.5% in 2007 Page 20

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DCA Vantage Product Guide 2009