AQT90 FLEX Radiometer Medical ApS 28/11/2018

RADIOMETER PRESENTATION 28/11/2018 RADIOMETER PRESENTATION Radiometer overview Radiometer overview No. of employees: 1,900 worldwide Products sold in more than 100 countries World leader in blood gas testing Develops blood gas and immunoassay analyzers as well as transcutaneous monitors and sensors Solutions for lab and point-of-care testing as well as patient monitoring RADIOMETER A/S RADIOMETER PRESENTATION 28-11-2018

RADIOMETER PRESENTATION 28/11/2018 RADIOMETER PRESENTATION AQT90 FLEX RADIOMETER A/S RADIOMETER PRESENTATION 28-11-2018

POCT - End-user needs Quality results Ease of use Safety Speed 28/11/2018 RADIOMETER PRESENTATION POCT - End-user needs Quality results Comparable to lab results Quality assurance Ease of use User steps have to be intuitive Simple processes Training must be easy (high staff turnover) Safety For users and patients Speed For every single patient result For handling multiple patients samples Connectivity Full integration into information systems Parameter flexibility Combination of relevant acute care tests Ability to choose multiple parameter of choice

RADIOMETER PRESENTATION 28/11/2018 RADIOMETER PRESENTATION AQT90 FLEX parameters Infection marker CRP Hemostasis marker D-dimer Pregnancy marker ßhCG Cardiac markers Myoglobin CKMB Troponin I NT-proBNP Troponin T Cardiac markers: Are all proteins. When a cardiac muscle cell dies, the content inside the cell (cardiac markers etc.) is released into the blood stream where we can measure them. Guideline: 30 minutes after arrival to the hospital, the diagnose AMI have to be established and treatment initialized (of course, if the patient suffers from a heart attack). Time = muscle. From Central lab it can easily take 2 hours before the doctor receive the answer of an acute blood sample. There might be many acute tests in central lab and the central lab staff don’t know which sample is the most acute. AQT90 FLEX can give the answer within 18 minutes which match the guidelines perfectly. Why do we have 3 parameters that all tell about AMI? Because they have a different “increase and decrease pattern” after an AMI. Myoglobin is the first parameter to reach the blood stream, but it’s not so specific. TnI is a late marker and it takes 4-6 hours before we can measure it in the blood after an AMI. But TnI is a very heart specific marker. So to be able to establish a fast and correct diagnose, it’s an advantage to have more than one marker. TnI is seen as the best marker of AMI due to the high specificity. Infection marker: One of the most frequent tests in the hospital. If you know the body temperature of the patient and the CRP level, you have a good indication of the patient’s condition. You can use CRP to distinguish between viral and bacterial infection. If you have a patient with fever and low CRP it’s probably a viral infection whereas if you have fever and high CRP it’s most likely a bacterial infection. D-dimer: All persons will always have some D-dimer in the blood. Every time we hurt ourselves and get a small bruises, the body will build a small blot clot to stop the bleeding. When this blood clot is broken down again, D-dimer will be a part of this breakdown process. That means that we only find D-dimer if there has been a blood clot. That’s also why we can use D-dimer to rule out diseases caused by excessive clotting. Negative D-dimer = rule out diseases due to excessive clotting. hCG: A hormone that supports pregnancy in the early weeks of pregnancy. hCG is responsible for the nausea that many women discover during pregnancy! Many women are admitted to the hospital because of abdominal pain. Just from looking at the woman, it can be very difficult for the doctor to tell what’s wrong. If hCG is negative, it rules out ectopic pregnancy. If we have a unconscious woman after e.g. trauma, it’s extremely important that we find out if she’s pregnant so we can treat her with the right medicine, x-ray etc. By having all the parameters it’s possible to rule out many dangerous diseases and conditions and the doctor can confirm the first diagnose that maybe was establish before the answers from the blood sample was ready. RADIOMETER A/S RADIOMETER PRESENTATION 28-11-2018

The AQT Measuring Cup & Technology Suzanne gave us an informative presentation on what makes a good or poor immunoassay We learned that testing for Tr is most difficult because of small quantities that present in the typical sample and the need for the test to be highly sensitive and specific. We also now know that the recent AQT linearity test results are very, very good. But you may ask where does the actual test take place and how does it actually work? Show the measuring cup! It is assumed that you have all completed your pre learner training and that you have at least the basic knowledge of immunochemistry? Lets look at the details of the measuring cup in the next slide NEXT SLIDE 28/11/2018 RADIOMETER A/S RADIOMETER PRESENTATION 28-11-2018

AQT measuring technology- Time resolved Flourescence (TRF) 28/11/2018 RADIOMETER PRESENTATION AQT measuring technology- Time resolved Flourescence (TRF) Whole Blood Unbound material will be washed off and cup dried ... plus buffer ... and signal read out ... stirred and incubated for a while 340 nm ... added to the cup Measurement cycle lasts 1 ms, repeated 1000 times Measuring time = 1s Improved Specificity RADIOMETER A/S RADIOMETER PRESENTATION 28-11-2018

AQT90 FLEX Easy testing - Testing in 3 steps 28/11/2018 RADIOMETER PRESENTATION AQT90 FLEX Easy testing - Testing in 3 steps Just choose the parameters and press start 1 Place the closed tube directly into the inlet 2 Choose parameters on screen and press start Results are printed and sent to the HIS/LIS or directly to patient monitors Testing in 3 steps Place the closed tube directly into the inlet. No sample preparation is required Whole blood measurement Choose parameters on screen and press start. The sample is automatically mixed and measured. After 30 seconds, the AQT90 FLEX is ready for the next sample. 3 RADIOMETER A/S RADIOMETER PRESENTATION 28-11-2018

AQT90 FLEX Easy Logistics 28/11/2018 RADIOMETER PRESENTATION AQT90 FLEX Easy Logistics Always ready - no need for filling analyzer with consumables before each test High on-board capacity - up to 240 test Only two types of consumables Cartridge Reagent Pack Easy logistics RADIOMETER A/S RADIOMETER PRESENTATION 28-11-2018

AQT90 FLEX Easy logistic - Cartridge 28/11/2018 RADIOMETER PRESENTATION AQT90 FLEX Easy logistic - Cartridge Each parameter-specific cartridge contains up to 16 test cups The instrument can be loaded with up to 15 cartridges according to your needs - maximum 240 tests Long term storage at 2-8 degrees C. Pre-barcoded cartridges for automatic loading into analyzer Ensures minimum time spent on replacements 15 Cartridge RADIOMETER A/S RADIOMETER PRESENTATION 28-11-2018

AQT90 FLEX Easy logistic – Reagent Pack 28/11/2018 RADIOMETER PRESENTATION AQT90 FLEX Easy logistic – Reagent Pack Same Reagent Pack for all parameters 1 Reagent Pack contains reagents and waste container for 200 tests 1 month on-board stability Storage at room temp Reagent Pack is discarded after use Reagent pack RADIOMETER A/S RADIOMETER PRESENTATION 28-11-2018

Correlations vs other TnI methods 28/11/2018 RADIOMETER PRESENTATION Correlations vs other TnI methods Correlation AQT90 FLEX TnI vs TnI Ultra n = 220 y = 0.148x - 0.012 R 2 = 0.98 50 300 Centaur TnI Ultra ng/mL AQT90 FLEX troponin I Correlation AQT90 FLEX TnI vs Architect TnI n = 174 y = 0.270x + 0.003 R 2 = 0.90 0.5 1.6 Architect TnI ng/mL AQT90 FLEXX troponin I Getting back to our assay. The AQT correlates well to other methods. Unfortunately we have not been able to check whether the samples giving values above the correlation lines are samples with autoantibodies. RADIOMETER A/S RADIOMETER PRESENTATION 28-11-2018

Correlation with Roche TnT 28/11/2018 RADIOMETER PRESENTATION Correlation with Roche TnT AQT TnT assay compared with Roche 4th & 5th Generation TnT assays on Elecsys 2010. Analytical specificity TnI The limit of detection has been determined to be <0.01 ug /L. Reportable range : 0.010 – 50 ug/L TnT The limit of detection has been determined to be 0.010 ug/L . Reportable range ; 0.010 –25 ug/ L Reference values ; The 99th percentile was determined to be 0.023ug/L [4] The 99th percentile was determined to be 0.017ug/L [4] Getting back to our assay. The AQT correlates well to other methods. Unfortunately we have not been able to check whether the samples giving values above the correlation lines are samples with autoantibodies. RADIOMETER A/S RADIOMETER PRESENTATION 28-11-2018

AQT90 Vs Cobas h232 Feature Cobas h232 AQT90 Flex 28/11/2018 RADIOMETER PRESENTATION AQT90 Vs Cobas h232 Feature Cobas h232 AQT90 Flex Contact with blood / waste Mannual pipetting. Risk of contact with blood. Test directly from Vaccutainer. Closed tube system. Closed waste disposal Aspiration Absent. Mannual. Chances of human error Automatic & precise Parameter menu Trop T , Ddimer , NTproBNP, Myoglobin, CKMB (only cardiac) Trop T , Trop I, D-Dimer , CKMB, Myoglobin, NT-proBNP, CRP, bHcG Flexibility One parameter at one time Upto 5 parameters from single sample. Upto Two sample tubes at one time. Technology Reflectance Time resolved Flouroscence. (improved specificity) . TAT 12 min – Trop T , 8 min Ddimer 18 min and then every 2 min. Throughput 3 –4 tests / hr 30 tests / hr QC Only Factory calibrated and dry lyophilised QC available Ext. QC from Biorad . 5 step internal QC check. Printer ABSENT . Mannualy transfer results In –built printer . Easy to record. Results measuring range SEMI QUANTITATIVE (eg, NT-proBNP upto 3000 pg/ml only) FULLY QUANTITATIVE – and highest linearity

AQT90 Vs Triage / Biosite Feature Triage / Biosite AQT90 Flex 28/11/2018 RADIOMETER PRESENTATION AQT90 Vs Triage / Biosite Feature Triage / Biosite AQT90 Flex Contact with blood / waste Mannual pipetting. Risk of contact with blood. Test directly from Vaccutainer. Closed tube system. Closed waste disposal Aspiration Absent. Mannual. Chances of human error Automatic & precise Parameter Trop I , CKMB , Myo, BNP , Ddimer Trop T , Trop I, Ddimer , CKMB, Myoglobin, NTproBNP, CRP, bhCG Flexibility Multiple markers on same strip. (Cardiac, SOB, Profiler ) Single testing only on BNP & Ddimer Upto 5 parameters from single sample. Upto Two sample tubes at one time. Technology Immunoflorescence Time resolved Flouroscence. (improved specificity) . TAT 18 min – Trop I + Thawing time(15min) 18 min and then every 2 min. Testing out of fridge Need to bring the strips to RT before testing. (approx. 15min) Directly out of fridge testing. No need for thawing. QC Only Factory calibrated and dry lyophilised QC available Ext. QC from Biorad . 5 step internal QC check. Results measuring range SEMI QUANTITATIVE (eg, BNP upto 10,000 pg/ml only) FULLY QUANTITATIVE – and lab equivalent linearity

AQT90 Flex - Uniqueness of assays 28/11/2018 RADIOMETER PRESENTATION AQT90 Flex - Uniqueness of assays Troponin : AQT Troponin assays are not sensitive to autologous antibodies hence lower probability of false negatives AQT Troponin assays are not affected by haemolysates AQT Trop I assays has good correlations with most other laboratory system assays AQT Trop T assay has excellent correlations with Roche 4th & 5th (hsTnT) Generation Trop T assays. D-Dimer : Higher specificity compared to any of the D-Dimer assays on market. AQT D-Dimer specificity – 71% and Sensitivity – 98% AQT D-Dimer assay linearity upto 100,000 ug/L on whole blood Automatic Onboard dilution Can use citrated sample also NT-proBNP : Lab equivalent measuring range – 12 – 35,000 pg/ml

AQT90 FLEX Truly meeting all end-user needs 28/11/2018 RADIOMETER PRESENTATION AQT90 FLEX Truly meeting all end-user needs Quality results  Ease of use Parameter flexibility Speed Safety Connectivity

Simpler Faster Better AQT90 FLEX 28/11/2018 RADIOMETER A/S RADIOMETER PRESENTATION 28-11-2018