Sphingotest bio-ADM Biomarker for Guidance of Vasopressor Administration in Acute Diseases

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Sphingotest bio-ADM Biomarker for Guidance of Vasopressor Administration in Acute Diseases
sphingotest® bio-ADM
Biomarker for Guidance of
Vasopressor Administration in Acute Diseases
Sphingotest bio-ADM Biomarker for Guidance of Vasopressor Administration in Acute Diseases
sphingotec’s Acute
                Disease Biomarkers
                sphingotec offers biomarkers for use in acute diseases. These biomarkers
                are used to help guide urgent clinical decisions in the emergency depart­
                ment and in intensive care units in hospitals.

                Acute diseases such as sepsis or acute myocardial infarction are often
                accompanied by shock that is initiated by systemic vasodilation and organ
                failure. In most cases this results in kidney failure. It is therefore an unmet
                medical need to identify and predict systemic vasodilation that may lead
                to shock and also to speedily identify and predict kidney failure in patients
                with sepsis or acute myocardial infarction.

                                                               sphingotec’s acute disease
                                                               biomarkers bio-ADM and
                                                               penKid do just that by
                                                               enabling early intervention
          Acute MI or Stroke                                   in these acute diseases.
                                                               The clinical use of these
                                                               biomarkers has been
                                                               validated by sphingotec in
                                                               the following settings:
Most patients                                                  sepsis, Acute Kidney Injury
                        ... are killed short term/midterm
survive > 1 day,
                            by comorbidities like
but ...                                                        (AKI) and acute myocardial
                                                               infarction (AMI).

                                      Micro-
                                                   Kidney
                    Infection      circulatory
                                                 Dysfunction
                                   Dysfunction

Biomarkers
                   Procalcitonin    bio-ADM        penKid
for diagnosis
Sphingotest bio-ADM Biomarker for Guidance of Vasopressor Administration in Acute Diseases
About the
                      bio-ADM Assay

The sphingotec bio-ADM assay (sphingotest®           however waiting too long may lead to a drop in
bio-ADM) is the only IVD method measuring the        blood pressure resulting in organs becoming
level of bioactive adrenomedullin by using a         insufficiently perfused at this stage. It is an unmet
sandwich of a C-terminal antibody specific for       medical need and of immense urgency to quickly
amide-terminus and an antibody avoiding the          identify patients with acute diseases in need of
N-terminal epitope leading to increased analyte      vasopressors so that vasopressors/catecholamines
stability.                                           can be administrated in emergency departments
                                                     and intensive care units at the right point of time.
The need for guidance of vasopressor
administration in acute diseases
According to standard care procedures in hos-
pitals, vasopressors are administered to a patient

                                                     sphingotest®
after the mean arterial pressure has dropped to
65mm Hg or below. Administrating vasopressors
to patients not needing them might be harmful,

                                                     bio-ADM
Sphingotest bio-ADM Biomarker for Guidance of Vasopressor Administration in Acute Diseases
Prediction and
diagnosis of circulation
dysfunction
bio-ADM (bioactive adrenomedullin) is a soluble peptide hormone with
a molecular weight of approximately 6kDa. Mainly released by endothelial
cells, its biological function is to control vasodilation, an important
regulator of blood pressure and organ perfusion1, 2.

This marker predicts and provides a diagnosis for circulation dysfunction.
The level of bio-ADM in blood samples of patients in acute condition may
be used as an early indicator for the need to administrator vasopressors/
catecholamines before the blood pressure of the patient drops to levels
that endanger the life of the patient.

  Healthy                      SEPSIS                                 SEVERE SEPSIS       SEPTIC SHOCK

  Normal                                           Systemic                     Organ
                                                                                                 Death
  blood flow                                       Vasodilation                 Failure

                         Adrenomedullin

1 Kitamura K et al. , Biochem Biophys Res Commun., 192:553–60, 1993
2 Ishimitsu T et al., Pharmacol Ther. 2006 Sep;111(3):909-27
Sphingotest bio-ADM Biomarker for Guidance of Vasopressor Administration in Acute Diseases
Evidence for the use
                    of bio-ADM in acute
                    myocardial infarction
                                   (AMI)3

STEMI (ST-Elevated Myocardial Infarction) and NSTEMI    bio-ADM                        Multivariate                    P value
(Non-ST-Elevated Myocardial Infarction) patients
                                                        MACE 1 year                    1.32 (1.09-1.59)                0.004
admitted to the University Hospitals of Leicester NHS
                                                        MACE 30 days                   1.37 (1.04-1.79)                0.023
Trust between August 2004 and April 2007 were
                                                        MACE 90 days                   1.39 (1.10-1.75)                0.005
included in a study conducted to investigate the
prognostic value of bio-ADM for MACE after              MI 1 years                     1.34 (1.03-1.75)                0.029
6 months or 2 years. MACE is defined as composite       Dead 1 year                    1.52 (1.12-2.05)                0.007
endpoint of all-cause mortality, heart failure (HF)     Dead/MI 1 year                 1.48 (1.20-1.82)
Prediction and
diagnosis of circulation
dysfunction
The association of bio-ADM with sepsis severity and outcome (28 day
mortality) in baseline and serial measurements has been investigated in
a Rome-based study where 101 consecutive patients (61 males
and 40 females) with median (IQR) age 78 (72 to 83 years) admitted to
the emergency department with suspected sepsis (at least two systemic
inflammatory response syndrome criteria plus clinical suspicion of
infection) were enrolled. Plasma samples for bio-ADM measurement were
taken and over the following four days and 28-day mortality rate was
recorded.

                                       bio-ADM was negatively correlated
                                       with mean arterial pressure
                                       (r = −0.39; P
Evidence for
                                                                     the use of
                                                             bio-ADM in sepsis4

             In addition the potential value of serial bio-ADM                              above 70 pg/mL every day until 4 days after
             measurement has been shown for prediction                                      admission. A 100% survival rate has been observed
             of 28-day mortality. At admission patients with a                              for those patients with decreased bio-ADM
             bio-ADM concentration above 70 pg/mL had a                                     concentrations below 70 pg/mL within 4 days after
             28-day survival rate of 55% which decreased to                                 admission.
             36% if the bio-ADM concentration had remained

100                                                                                          100
Proportion of patients surviving (%)

                                                                                             Proportion of patients surviving (%)

                         0                                                                                            0
                                       0             7               14        21   28                                              0             7              14                 21   28
                                           ADM, 0 < 70, n = 61, events = 11                                                             ADM, 0 > 70, ADM, 4 < 70, n = 12, events = 0
                                           ADM, 0 < 70, n = 40, events = 18                                                            ADM, 0 > 70, ADM, 4 > 70, n = 28, events = 18
                                            p = 0.00341                                                                                  p = 0.00052

             Illustration of added value of serial bio-ADM measurement. Kaplan-Meier Plots for survival are shown for patients with bio-ADM values above or below 70 pg/mL
             on admission (left) and for the subgroup of patients, who were above 70 pg/mL on admission and spread into those with bio-ADM values above or below 70 pg/mL
             4 days later (right).

             4 Marino R et al. Critical Care 2014, 18:R34
sphingotec GmbH aims to develop diagnostic methods for prediction, prevention,
intervention strategies and early treatment of diseases in the fields of cancer,
cardiovascular diseases and kidney function. In order to realize this mission we
provide biomarkers indicating susceptibility for a specific disease which enables the
monitoring of prevention and intervention strategies. The company was established
in 2002 by Dr. Andreas Bergmann who is one of the founders and managers of
BRAHMS Aktiengesellschaft where, in addition to several other biomarkers, the
sepsis marker Procalcitonin (B.R.A.H.M.S PCT®: www.procalcitonin.com) was
developed in his role as Chief Research Officer. This biomarker Procalcitonin created
a new diagnostic standard of care supporting patient management in sepsis.
sphingotec is located in Hennigsdorf, northwest of Berlin, Germany, with its facilities
in the Technology Campus one of the largest industrial parks in Berlin and
Brandenburg with several companies of the biotechnology branch located there.

                                                                                          Images: Thinkstockphoto, sphingotec | WE-EN-ADM_R001
Further information can be obtained here:

sphingotec GmbH
Neuendorfstrasse 15A, 16761 Hennigsdorf
Germany
Phone +49 33 02/2 05 65-0
info@sphingotec.com, www.sphingotec.com
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