Point-of-care testing for advanced patient stratification

Christoph Wissmann Global Senior Product ManagerPoint of Care Diagnostics

Seville, May 25th 2015

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New global collaborationThermo Fisher Scientific is the global collaboration partner of Samsung for commercialization and co-development of innovative solutions in the POC Testing market. Together we provide excellent expertise in clinical diagnostics to fulfill customer needs and improve patient management.

Collaboration – Technical & Diagnostic Excellence

SamsungLABGEO IB10

Immunoassay Analyzer

SamsungLABGEO HC10

Hematology Analyzer

SamsungLABGEO PT10

Clinical Chemistry Analyzer

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Pre-hospital Testing for cTnI while in transit via the Scottish Ambulance Service

•Average transport time to BGH was 28 min with a maximum time of 1h 10min

•~80% of all transports had cTnI test results available on or prior to arrival at BGH

•There is ~2½ h difference in availability of results when testing is performed by SAS

•Of 9 transport-positive – 4 significantly elevated for in transit decision

Scotish Ambulance Service Hospital

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Early rule-out of Suspected Acute Coronary Syndrome (ACS)

~12% of these ED patients present with CHEST PAIN

Only 1 in 10 has a AMI!!

UNMET MEDICAL NEED: Fast rule-in of MI is crucial but Fast MI rule-out

as well Including:Fast, precise and safe exclusion of MI

& Risk-Stratification & Prognostic evaluation for the majority of patients

Mockel M et al., Eur J Emerg Med 2013

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Copeptin (AVP) immediately released from the hypophysis

Hemodynamic Stress

Acute Coronary Syndrome

Acute Myocardial Infarction

(AMI)

Copeptin (surrogate marker of Vasopressin) in Acute Coronary Syndrome (ACS)

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At initial presentation üStrategic complement for the (hs) Troponin test in ruling-out AMIüSafety and efficacy demonstrated in Interventional Trial (BIC-8)üNO Troponin retesting needed after >=3 hoursüPatient can be discharged from ED if Troponin and Copeptin are

negative <1h.üSaves significant stakeholder’s time & hospital resources

Copeptin + Tn strategy already included in 2015 in the German cardiac guidelinesGerman cardiac guidelines

Copeptin (surrogate marker of Vasopressin) in Acute Coronary Syndrome (ACS)

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Reichlin et al., 2009 • Proof of Concept• Combination of

Cop and Trop has the highest NPV 99,7%) for rule-out AMI

Giannitsis et al., 2011• Added value

of Copeptin in combination with hsTn to rule-out AMI

Maisel et al, 2013• Chopin study,

Observational, Multicenter study

• Shows high NPV 99,2% and the improvements in risk stratification and prognosis in addition to Troponin

Mockel et al, 2014• BIC-8

Interventional, multicenter study

• Shows it is safe and can be used in clinical routine

Lipinski et al, 2014• Review with

more than 9000 patients

• Shows improvement of NPV together with conventional or hs-Trop

Combine Copeptin and Troponin – Scientific Evidences

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What are the unmet needs in heart failure diagnosis?

• Need for rapid assessment of patients with suspected pneumonia so that antibiotics can be initiated as quickly as possible

• Diagnosis of pneumonia difficult in patients with pre-existing lung disease

• Detecting superimposed pneumonia on top of acute heart failure challenging

• Until recently, biomarkers have not been extensively studied for their ability to identify pneumonia in the setting of AHF

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CAP in hospitalized HF patients

Retrospective observational analysis

Hospital admitted HF patients: 17% have additional CAPIn-hospital Mortality: 10,5% (CAP) vs. 4,7% (Non-CAP)

Paz, J. et al., ESC Heart Failure 2013, Lisbon

CAP is associated with a poor outcome for patients hospitalized with HF

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Use of PCT for the diagnosis of pneumonia in patients with dyspnoea

; ; ; ; N=499

Reduction of uncertainty by 82% if pneumonia ruled out by PCT < 0.25 µg/L

N=155

Maisel A et al. Eur J Heart Fail 2012;14:278-286

Diagnostic certainty of Pneumonia

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Time to result - Point of Care vs. Lab

B·R·A·H·M·S PCT direct results are available within 25 min after blood draw!

Lab results take 2:16 h with a maximal time of up to 7:28 h

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PCT IN CLINICAL GUIDELINES• Surviving Sepsis Campaign Guidelines 2012

• Guidelines for the management of adult lower respiratory tract infections• EMA - Expert Meeting on Neonatal and Pediatric Sepsis

• Local guideline Xi’an province• Guidelines for Quality Control in ED & ICU of Shanghai• Expert Consensus: PCT in emergency clinical usage

• Practice guidelines for acute bacterial meningitides• Management of lower respiratory tract infections in immunocompetent adults

• Prevention, diagnosis, therapy and follow-up care of sepsis• Epidemiology, diagnosis, antimicrobial therapy and management of CAP and LRTI in adults• Recommendations for calculated parenteral initial therapy of bacterial disease in adults• Strategies securing rational antibiotic use in hospitals• Epidemiology, diagnostic and therapy of adult patients with nosocomial pneumonia

• Definitions - Diagnostic Approach - Treatment Guidelines

• Tuscan Guidelines for Neonatal infections

• The Japanese Guidelines for the Management of Sepsis• Guidelines for the management of acute pancreatitis• Practical guideline of Febrile Neutropenia• ICU Infection Prevention Guideline• Guidelines for clinical testing

• Recommendations for the initial and multidisciplinary diagnostic management of severe sepsis in the hospital ED• Consensus statement on management of severe sepsis and septic shock in pediatrics• SEPAR Guidelines for nosocomial pneumonia• Multidisciplinary guidelines for the management of community-acquired pneumonia

• Swedish Medical Society: Severe sepsis and septic shock – early identification and initial management• Swedish guidelines on the management of community-acquired pneumonia in immuncompetent adults

• Diagnosis and Management of Chronic Obstructive Pulmonary Disease

• Guidelines for evaluation of new fever in critically ill adult patients• The Management of Community-Acquired Pneumonia in Infants and Children Older Than 3 Months of Age

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IMPACT - Improved Management of heart failure with ProcAlCiTonin• Primary objective

• Demonstrate the advantage of antibiotic treatment including information on PCT level over established treatment practice with respect to outcome.

• First patient inclusion in April/15• Additional sites Germany, Denmark, Netherlands, Spain

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Routine clinical assessment chief complaint SOB

PCT guided group N= 315 PCT blind group N= 315

blood sampling, PCT measurement blood sampling

PCT > 0.2 PCT =<0.2

+ Abx -ABx

Follow-upPCT day 1

Standard diagnostics

Follow-upPCT day 1

+ ABx - ABx

Follow up blood sample day 1

InformedConsent, Evaluation of In/Exclusion Criteria

Randomization

Presentationin the ED

8-24 h

Max

. 8 h

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• Development of new applications• Ensure highest accuracy combined with 24/7 accessibility• Availability within minutes

Collaboration – Technical & Diagnostic Excellence

SamsungLABGEO IB10

Immunoassay Analyzer

SamsungLABGEO HC10

Hematology Analyzer

SamsungLABGEO PT10

Clinical Chemistry Analyzer

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Thank you for your attention!

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