Roche Diagnostics Operations, Inc.

Roche Molecular Systems, Inc.

University of Toronto

Epigenomics Ag

Roche Diagnostics Gmbh

F. Hoffmann-La Roche Ag

Dirk Block

Ursula-Henrike Wienhues-Thelen

Christian Zaugg

Thomas Dieterle

Johann Karl

Edelgard Anna Kaiser

Georg Hess

Hendrik Huedig

Andre Ziegler

Peter Liu

Hans-Peter Brunner

Andrew Emili

Serge Masson

Roberto Latini

Anthony Gramolini

David MacLennan

Herbert Von Der Eltz

Thomas Walter

Christine Markert-Hahn

Ralf Zielenski

Joerg Kleiber

Vincent Fong

Ruth Isserlin

Thomas Kislinger

Manuela Poignee-Heger

Ruediger Haenel

Andrea Horsch

Vinzent Rolny

Peter Kastner

Johan Ubby

Julian Braz

Sara Arab

Sandra Sanders-van Wijk

Cheryl Mitchell

James Januzzi

Frank Bergmann

Herbert Andres

Dietmar Zdunek

Fabian Model

Alfred Engel

Rosemarie Kientsch-Engel

Friedemann Krause

Monika Soukupova

Martin Hund

Stefan Palme

Sandra Rutz

Simona Barlera

Hanspeter Brunner

Markus Thomas

Joerg Kleibler

Birgit Klapperich

Hendrik Heudig

Ekaterina Manuilova

Christina Rabe

Christine Boehm

Sabine Vogel-Ziebolz

David Maclennan

Edelgard Kaiser

Sandra Sanders-Van Wijk

Anna Edelgard Kaiser

Hendrik HÜDIG

Christine Market-Hahn

Christine BÖHM

James Creeden

Hans-Jurgen Loyda

Christine Bohm

Hendrik Hudig

Vincent Rolny

André Ziegler

Methods for predicting the risk of a subject of rapidly progressing to chronic heart failure and/or of hospitalization due to chronic heart failure and/or death are disclosed. The method is based on the determination of at least one biomarker selected from the group consisting of a BNP-type peptide, IGFBP7 (IGF binding protein 7), a cardiac Troponin, soluble ST2 (sST2), FGF-23 (Fibroblast Growth Factor 23), and Growth Differentiation Factor 15 (GDF-15), in a sample of a subject. The method may further encompass the assessment of the presence or absence of (i) abnormal midwall fractional shortening or (ii) left ventricular hypertrophy. Further envisaged by the present invention are devices adapted to carry out the present invention.

Biomarkers for risk prediction of mortality

Methods for identifying a patient who is eligible for an intensification of heart failure therapy are disclosed. Furthermore, methods for optimizing B-type natriuretic peptide (BNP) and/or N-terminal pro B-type natriuretic peptide (NT-proBNP)-type peptide guided heart failure therapy are disclosed. The methods are based on the measurement of the level of at least one marker in a sample from a patient who has heart failure and who receives B-type natriuretic peptide (BNP) and/or N-terminal pro B-type natriuretic peptide (NT-proBNP)-type peptide guided heart failure therapy. Further described are kits and devices adapted to carry out the described methods.

Biomarkers for risk assessment and treatment monitoring in heart failure patients guided by natriuretic peptides

The present disclosure relates to a method for diagnosing preeclampsia or a preeclampsia-related condition in a pregnant subject. The method is based on the measurement of the amount of the biomarker IGFBP-7 (Insulin-like Growth Factor Binding Protein 7) in a sample from the subject and on the comparison of the measured amount to a reference. Also disclosed are methods for assessing the severity of preeclampsia or a preeclampsia-related condition and methods for monitoring a preeclampsia or a preeclampsia-related condition in a pregnant subject. The present disclosure further relates to the use of the biomarker IGFBP-7 or of an agent that specifically binds to IGFBP-7 in a sample from a pregnant subject for diagnosing, for monitoring or for assessing the severity of preeclampsia or a preeclampsia-related condition. Finally, the present disclosure relates to a device or kit adapted to carry out the method of the present invention.

IGFBP-7 as a marker of preeclampsia

A method for predicting the risk of recurrence of Atrial Fibrillation in a subject based on measuring the amount of the biomarker Angiopoietin-2 (Ang-2) and optionally of at least one further biomarker in a sample from the subject is described. Also described is a method of diagnosing Atrial Fibrillation in a subject suspected to suffer from Atrial Fibrillation based on measuring the amount of the biomarker Angiopoietin-2 (Ang-2) and optionally of at least one further biomarker in a sample from the subject. Also described are devices adapted to carry out the method of the present disclosure.

Circulating Angiopoietin-2 (Ang-2) for the prediction of recurrence of atrial fibrillation

The present disclosure is directed to a method of identifying a patient having heart failure as likely to respond to a therapy with a statin. The method is based on measuring the level of at least one marker selected from GDF-15 (Growth Differentiation Factor 15), Urea, SHBG (Sex Hormone-Binding Globulin), Uric acid, PLGF (Placental Growth Factor), IL-6 (Interleukin-6), Transferrin, a cardiac Troponin, sFlt-1 (Soluble fms-like tyrosine kinase-1), Prealbumin, Ferritin, Osteopontin, sST2 (soluble ST2), and hsCRP (high sensitivity C-reactive protein) in a sample from a patient. Further envisaged is a method of predicting the risk of a patient to suffer from death or hospitalization, wherein the patient has heart failure and undergoes a therapy with a statin. The method is also based on the measurement of the level of at least one of the aforementioned markers.

Marker for statin treatment stratification in heart failure

The present invention relates to a method for assessing whether a subject shall be subjected to an imaging based diagnostic assessment. The method is based on the determination of the amount(s) of a cardiac Troponin and/or Fibroblast Growth Factor 23 (FGF-23) in a sample from the subject, and on the comparison of the, thus, determined amount(s) with a reference amount (reference amounts). The present invention also relates to a system for performing an assessment whether a subject shall be subjected to an imaging based diagnostic assessment and to reagents and kits used in performing the methods disclosed herein. Moreover, the present invention is directed to a method for predicting the risk of mortality and/or of a cardiovascular event. Also encompassed is a method for diagnosing an early stage of LVH in a subject having a preserved left ventricular ejection.

Assessing whether a subject shall be subjected to imaging based diagnostic

The present disclosure describes a method for predicting the risk of a patient to suffer from acute kidney injury (AKI) during or after a surgical procedure or after administration of a contrast medium. The method is based on the determination of the level of the biomarker IGFBP7 (Insulin-like Growth Factor Binding Protein 7) in a body fluid sample obtained from the patient prior to the surgical procedure or prior to the administration of a contrast medium. Further, the present disclosure describes a method for predicting the risk of a patient to suffer from acute kidney injury (AKI) based on the determination of the amount of the biomarker IGFBP7 (Insulin-like Growth Factor Binding Protein 7) and Cystatin C in a body fluid sample obtained from the patient. The present disclosure further encompasses kits and devices adapted to carry out the methods of the disclosed methods.

IGFBP7 for prediction of risk of AKI when measured prior to surgery

Presented is a method for diagnosing and/or grading diastolic dysfunction or at least one structural or functional abnormality associated with diastolic dysfunction. The method involves measuring the level of IGFBP7 (Insulin like growth factor binding protein 7) and, optionally, the level of at least one further marker in a patient suffering from heart failure, and comparing the level to a reference level. Further envisaged is a method of monitoring diastolic function in a patient suffering from heart failure. Also described are kits and devices adapted to carry out the method.

IGFBP7 for diagnosing diastolic dysfunction

Disclosed is a method for assessing heart failure in vitro including the steps of measuring in a sample the concentration of the marker IGFBP-7, of optionally measuring in the sample the concentration of one or more other marker(s) of heart failure, and of assessing heart failure by comparing the concentration determined in for IGFBP-7 and the concentration(s) determined for the optionally one or more other marker to the concentration of this marker or these markers as established in a reference population. Also disclosed are the use of IGFBP-7 as a marker protein in the assessment of heart failure, a marker combination comprising IGFBP-7 and a kit for measuring IGFBP-7.

Use of IGFBP-7 in the assessment of heart failure

Methods and systems for diagnosing functional and/or structural abnormalities of the heart preceding heart failure, and for predicting the risk of developing heart failure, in a subject comprising measuring a cardiac troponin in a sample and comparing the measurement to a reference value. Other markers, including GDF15 and IGFBP7 are also measured in some embodiments.

Use of biomarkers in the assessment of the early transition from arterial hypertension to heart failure

The present description relates to a method for identifying a patient who is eligible for an intensification of heart failure therapy. Furthermore, the description relates to a method for optimizing B type natriuretic peptide (BNP) and/or N-terminal pro B-type natriuretic peptide (NT-proBNP)-type peptide guided heart failure therapy. The methods are based on the measurement of the level of at least one marker in a sample from a patient who has heart failure and who receives B-type natriuretic peptide (BNP) and/or N-terminal pro B-type natriuretic peptide (NT-proBNP)-type peptide guided heart failure therapy. Further described are kits and devices adapted to carry out the described method.

Described is a method for predicting the risk of a subject of rapidly progressing to chronic heart failure and/or of hospitalization due to chronic heart failure and/or death. The method is based on the determination of at least one biomarker selected from B-type natriuretic peptide (BNP) or N-terminal pro B-type natriuretic peptide (NT-proBNP), IGFBP7 (IGF binding protein 7), a cardiac Troponin, soluble ST2 (sST2), FGF-23 (Fibroblast Growth Factor 23), and Growth Differentiation Factor 15 (GDF-15), in a sample of a subject along with the assessment of the presence or absence of (i) abnormal midwall fractional shortening or (ii) left ventricular hypertrophy.

Disclosed herein is a method for diagnosing and/or grading diastolic dysfunction or at least one structural or functional abnormality associated with diastolic dysfunction. The method involves measuring the level of IGFBP7 (Insulin like growth factor binding protein 7) and, optionally, the level of at least one further marker in a patient suffering from heart failure, and comparing the level to a reference level. Also disclosed is a method of monitoring diastolic function in a patient suffering from heart failure, and kits and devices for performing the method.

The present invention is directed to a method of identifying a patient having heart failure as likely to respond to a therapy comprising a statin. The method is based on measuring the level of at least one marker selected from GDF-15 (Growth Differentiation Factor 15), Urea, SHBG (Sex Hormone-Binding Globulin), Uric acid, PLGF (Placental Growth Factor), IL-6 (Interleukin-6), Transferrin, a cardiac Troponin, sFlt-1 (Soluble fms-like tyrosine kinase-1), Prealbumin, Ferritin, Osteopontin, sST2 (soluble ST2), and hsCRP (high sensitivity C-reactive protein) in a sample from a patient. Further envisaged is a method of predicting the risk of a patient to suffer from death or hospitalization, wherein said patient has heart failure and undergoes a therapy comprising a statin. The method is also based on the measurement of the level of at least one of the aforementioned markers.

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Dirk Block