Thermo fischer scientific point of care testing for advanced patient stratification

1. Point-of-care testing for advanced
patient stratification
Christoph Wissmann Global Senior Product Manager
Point of Care Diagnostics
Seville, May 25th 2015

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New global collaboration
Thermo 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
Samsung
LABGEO IB10
Immunoassay Analyzer
Samsung
LABGEO HC10
Hematology Analyzer
Samsung
LABGEO 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 AMI
üSafety and efficacy demonstrated in Interventional Trial (BIC-8)
üNO Troponin retesting needed after >=3 hours
üPatient 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 CAP
In-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
•
Routineclinical assessment  chief complaint SOB
PCT guided group N= 315 PCT blindgroup N= 315
blood sampling, PCT measurement bloodsampling
PCT > 0.2 PCT =<0.2
+ Abx -ABx
Follow-up
PCT day 1
Standard diagnostics
Follow-up
PCT day 1
+ ABx - ABx
Followup blood sample
day1
InformedConsent, Evaluationof In/Exclusion Criteria
Randomization
Presentationin the ED
8-24h
Max.8h

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• Development of new applications
• Ensure highest accuracy combined with 24/7 accessibility
• Availability within minutes
Collaboration – Technical & Diagnostic Excellence
Samsung
LABGEO IB10
Immunoassay Analyzer
Samsung
LABGEO HC10
Hematology Analyzer
Samsung
LABGEO PT10
Clinical Chemistry Analyzer

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Thank you for your attention!
Please visit us at booth no B50