Disclosed are method and apparatus for identifying biomarkers and in particular for identifying biomarkers for use in making clinical assessments, such as early diagnostic, diagnostic, disease stage, disease severity, disease subtype, response to therapy or prognostic assessments. In one particular example, the techniques are applied to allow assessments of patients suffering from, suspected of suffering from, or with clinical signs of SIRS (Systemic Inflammatory Response Syndrome) being either infection-negative SIRS or infection-positive SIRS.
C12Q 1/6883 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
C12Q 1/689 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for bacteria
G16B 25/00 - ICT specially adapted for hybridisationICT specially adapted for gene or protein expression
G16B 25/10 - Gene or protein expression profilingExpression-ratio estimation or normalisation
Disclosed are methods, apparatus, kits and compositions for determining the absence of a systemic bacterial infection (sepsis) in patients, particularly ones presenting to hospital emergency departments (ED) as outpatients, by measurement of the host immune response using peripheral blood. The are methods, apparatus, kits and compositions can be used in mammals for diagnosing, making treatment decisions, determining the next procedure or diagnostic test, or management of patients suspected of having an infection, including those presenting with fever or other signs of systemic inflammation. More particularly, peripheral blood RNA and protein biomarkers are disclosed that are useful for distinguishing between the host immune response to bacteria compared to the host immune response to other causes of systemic inflammation including trauma, burns, autoimmune disease, asthma, anaphylaxis, arthritis, obesity and viral infections. As such, the biomarkers are useful for distinguishing bacterial-associated systemic inflammatory response syndrome from non-bacterial systemic inflammation to provide clinicians with strong negative predictive value (>95%) so that sepsis can be excluded as a diagnosis in patients presenting to ED with clinical signs of systemic inflammation.
G01N 33/569 - ImmunoassayBiospecific binding assayMaterials therefor for microorganisms, e.g. protozoa, bacteria, viruses
A61B 5/00 - Measuring for diagnostic purposes Identification of persons
C12Q 1/6883 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
G01N 33/574 - ImmunoassayBiospecific binding assayMaterials therefor for cancer
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
(1) Biological chemical test kits for medical laboratory use in analysis of gene expression, protein expression, metabolite impression, inflammation, immune-suppression, immune disorders, for diagnosis and treatment of sepsis.
(2) Clinical diagnostic preparations for medical and veterinary use, namely diagnostic preparations for clinical laboratory use, for medical and veterinary laboratory use, for medical and veterinary research use, and for medical and veterinary diagnostic use; biological chemical test kits for medical laboratory use in analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders.
(3) Surgical and medical apparatus and instruments for use in the field of the analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders; diagnostic test apparatus for analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders; diagnostic testing kits consisting primarily of probes, buffers and reagents for use in microbial testing; point of care medical devices, namely medical instruments for the analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders. (1) Medical services, namely, medical diagnostic services, medical testing services, medical laboratory services, and medical counseling in the field of the analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, and immune disorders; medical pathology services, namely for the analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders; medical and pathology services being the analysis of body fluid samples; medical services being molecular diagnostic services, namely, taking of body fluid samples of others; information, advisory and consultancy services in relation to the aforementioned services.
05 - Pharmaceutical, veterinary and sanitary products
09 - Scientific and electric apparatus and instruments
10 - Medical apparatus and instruments
16 - Paper, cardboard and goods made from these materials
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
(1) Diagnostic preparations for medical and veterinary laboratory and research use; diagnostic preparations for medical and veterinary use for detecting sepsis; immunological, genetic, biological, chemical and multiple pathogen DNA test kits comprised of medical diagnostic reagents used for medical laboratory analysis to diagnose the presence of sepsis and treat sepsis infection.
(2) Computer software and application software for use in conveying information in relation to medical testing and results of medical testing; electronic publications in the field of medical tests and results of medical tests; computer software and pre-recorded discs featuring algorithms for diagnosing probability of having sepsis infection.
(3) Surgical and medical apparatus and instruments in the field of sepsis infections; diagnostic tests for diagnosing sepsis infections; diagnostic testing kits for diagnosing sepsis infections.
(4) Printed matter, namely printed publications in the field of medical tests and results of medical tests; paper-based forms for medical reports and test results. (1) Medical services, namely medical diagnostic services, medical testing services, medical laboratory services, and medical counselling in the field of autoimmune diseases, immunologic deficiency syndromes, and sepsis; medical pathology services in the field of molecular diagnostics for and treatment of inflammation arising from infections of the blood, sepsis infections, for the diagnosis and treatment of immune disorders; medical and pathology services in the field of medical testing for sepsis; medical services being molecular diagnostic services, namely, taking of body fluid samples of others; information, advisory and consultancy services in relation to the aforementioned services.
5.
Treating or inhibiting severe sepsis based on measuring defensin alpha 4 (DEFA4) expression
Disclosed is a method for treating or inhibiting the development of severe sepsis in a subject based on measuring the level of a defensin alpha 4 (DEFA4) polynucleotide expression product.
C12Q 1/6883 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
C12Q 1/689 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for bacteria
G16B 25/00 - ICT specially adapted for hybridisationICT specially adapted for gene or protein expression
G16B 25/10 - Gene or protein expression profilingExpression-ratio estimation or normalisation
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Biological chemical test kits for medical laboratory use in analysis of gene expression, protein expression, metabolite impression, inflammation, immune-suppression, immune disorders, for diagnosis and treatment of sepsis. Clinical diagnostics for medical or veterinary use; biological chemical test kits for medical laboratory use in analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders. Surgical and medical apparatus and instruments; diagnostic tests; diagnostic testing kits in this class; point of care medical devices. Medical services; pathology services; medical and pathology services being the analysis of body fluid samples; medical services being molecular diagnostic services; taking of body fluid samples of others; information, advisory and consultancy services in relation to the aforementioned.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Biological chemical test kits for medical laboratory use in analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders, for diagnosis and treatment of sepsis Clinical diagnostics for medical or veterinary use; biological chemical test kits comprised of medical diagnostic reagents and assays for medical laboratory use in analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders Surgical and medical apparatus and instruments for use in analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders; peripheral blood or immune cell diagnostic test apparatus for analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders; diagnostic testing kits in this class consisting primarily of probes, buffers and reagents for use in microbial testing; point of care medical devices, namely, devices using nucleic acid amplification in the nature of real-time polymerase chain reaction or isothermal amplification, DNA sequencing or analyte quantification in the nature of mass spectrometry, protein array for analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders Medical services; medical pathology services; medical pathology services being the analysis of body fluid samples; medical services being molecular diagnostic services and taking of body fluid samples of others; providing information, advisory and consultancy services in relation to medical services, medical pathology services, the analysis of body fluid samples, medical services being molecular diagnostic services and taking of body fluid samples of others
8.
Use of C3AR1 as a biomarker in methods of treating inflammatory response syndromes
Disclosed are methods for treating or inhibiting the development of infection-negative systemic inflammatory response syndrome (inSIRS) or infection-positive systemic inflammatory response syndrome (ipSIRS) based on the use of complement component 3a receptor 1 (C3AR1) as a biomarker for differentiating between inSIRS and ipSIRS.
C12Q 1/6883 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
G16B 25/00 - ICT specially adapted for hybridisationICT specially adapted for gene or protein expression
C12Q 1/689 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for bacteria
Disclosed are compositions, methods and apparatus for diagnosing and/or monitoring a virus-associated systemic inflammation by measurement of a host immune response. The invention can be used for diagnosis including early diagnosis, monitoring, making treatment decisions, or management of subjects suspected of having systemic inflammation associated with an infection. More particularly, the present disclosure relates to peripheral blood RNA and protein biomarkers that are useful for specifically distinguishing between the host systemic immune response to viruses as compared to the host immune response to other causes of systemic inflammation.
C12Q 1/6883 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
G01N 33/68 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing involving proteins, peptides or amino acids
C12Q 1/70 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving virus or bacteriophage
A method for validating quantification of biomarkers, the biomarkers being quantified using a quantification technique of a selected type, and the method including determining a plurality of biomarker values, each biomarker value being indicative of a value measured or derived from a measured value, for at least one corresponding biomarker of the biological subject and being at least partially indicative of a concentration of the biomarker in a sample taken from the subject, determining at least one control value by determining a combination of biomarker values, comparing each control value to a respective control reference and determining if the biomarker values are valid using results of the comparison.
G06F 19/20 - for hybridisation or gene expression, e.g. microarrays, sequencing by hybridisation, normalisation, profiling, noise correction models, expression ratio estimation, probe design or probe optimisation
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
G06F 19/24 - for machine learning, data mining or biostatistics, e.g. pattern finding, knowledge discovery, rule extraction, correlation, clustering or classification
11.
SYSTEMIC INFLAMMATORY AND PATHOGEN BIOMARKERS AND USES THEREFOR
Disclosed are compositions, methods and apparatus for diagnosing and/or monitoring an infection by a bacterium, virus or protozoan by measurement of pathogen- associated and non-infectious systemic inflammation and optionally in combination with detection of a pathogen specific molecule. The invention can be used for diagnosis, including early diagnosis, ruling-out, ruling-in, monitoring, making treatment decisions, or management of subjects suspected of, or having, systemic inflammation. More particularly, the present disclosure relates to host peripheral blood RNA and protein biomarkers, which are used in combination, and optionally with peripheral blood broad-range pathogen-specific detection assays, that are useful for distinguishing between bacterial, viral, protozoal and non-infectious causes of systemic inflammation.
The present invention discloses methods, kits, and apparatus as well as reagents and compositions associated therewith for deriving an indicator for use in diagnosing the presence, absence or degree of at least one condition in a biological subject or in prognosing at least one condition in a biological subject. Also disclosed is a biomarker signature for use in diagnosing the presence, absence or degree of at least one condition in a biological subject or in prognosing at least one condition in a biological subject. The present invention further discloses methods, kits and apparatus, as well as reagents and compositions associated therewith, for identifying biomarkers for use in a biomarker signature.
C12Q 1/6883 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
G16B 25/00 - ICT specially adapted for hybridisationICT specially adapted for gene or protein expression
G16B 40/00 - ICT specially adapted for biostatisticsICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding
Disclosed are methods, apparatus, kits and compositions for determining the absence of a systemic bacterial infection (sepsis) in patients, particularly ones presenting to hospital emergency departments (ED) as outpatients, by measurement of the host immune response using peripheral blood. The are methods, apparatus, kits and compositions can be used in mammals for diagnosing, making treatment decisions, determining the next procedure or diagnostic test, or management of patients suspected of having an infection, including those presenting with fever or other signs of systemic inflammation. More particularly, peripheral blood RNA and protein biomarkers are disclosed that are useful for distinguishing between the host immune response to bacteria compared to the host immune response to other causes of systemic inflammation including trauma, burns, autoimmune disease, asthma, anaphylaxis, arthritis, obesity and viral infections. As such, the biomarkers are useful for distinguishing bacterial-associated systemic inflammatory response syndrome from non-bacterial systemic inflammation to provide clinicians with strong negative predictive value (>95%) so that sepsis can be excluded as a diagnosis in patients presenting to ED with clinical signs of systemic inflammation.
Disclosed are compositions, methods and apparatus for diagnosing and/or monitoring a herpesvirus-associated systemic inflammation by measurement of a host immune response. These compositions, methods and apparatus can be used for diagnosis including early diagnosis, monitoring, making treatment decisions, or management of subjects suspected of having systemic inflammation associated with a herpesvirus infection. More particularly, the present invention discloses peripheral blood RNA and protein biomarkers that are useful for specifically distinguishing between the host systemic immune response to herpesviruses as compared to the host immune response to other causes of systemic inflammation, including other types of viruses.
Disclosed are compositions, methods and apparatus for diagnosing and/or monitoring a virus-associated systemic inflammation by measurement of a host immune response. The invention can be used for diagnosis including early diagnosis, monitoring, making treatment decisions, or management of subjects suspected of having systemic inflammation associated with an infection. More particularly, the present disclosure relates to peripheral blood RNA and protein biomarkers that are useful for specifically distinguishing between the host systemic immune response to viruses as compared to the host immune response to other causes of systemic inflammation.
A method for validating quantification of biomarkers, the biomarkers being quantified using a quantification technique of a selected type, and the method including determining a plurality of biomarker values, each biomarker value being indicative of a value measured or derived from a measured value, for at least one corresponding biomarker of the biological subject and being at least partially indicative of a concentration of the biomarker in a sample taken from the subject, determining at least one control value by determining a combination of biomarker values, comparing each control value to a respective control reference and determining if the biomarker values are valid using results of the comparison.
G06F 19/20 - for hybridisation or gene expression, e.g. microarrays, sequencing by hybridisation, normalisation, profiling, noise correction models, expression ratio estimation, probe design or probe optimisation
A method for validating quantification of biomarkers, the biomarkers being quantified using a quantification technique of a selected type, and the method including determining a plurality of biomarker values, each biomarker value being indicative of a value measured or derived from a measured value, for at least one corresponding biomarker of the biological subject and being at least partially indicative of a concentration of the biomarker in a sample taken from the subject, determining at least one control value by determining a combination of biomarker values, comparing each control value to a respective control reference and determining if the biomarker values are valid using results of the comparison.
G01N 35/00 - Automatic analysis not limited to methods or materials provided for in any single one of groups Handling materials therefor
G06F 19/20 - for hybridisation or gene expression, e.g. microarrays, sequencing by hybridisation, normalisation, profiling, noise correction models, expression ratio estimation, probe design or probe optimisation
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving nucleic acids
Disclosed are method and apparatus for identifying biomarkers and in particular for identifying biomarkers for use in making clinical assessments, such as early diagnostic, diagnostic, disease stage, disease severity, disease subtype, response to therapy or prognostic assessments. In one particular example, the techniques are applied to allow assessments of patients suffering from, suspected of suffering from, or with clinical signs of SIRS (Systemic Inflammatory Response Syndrome) being either infection-negative SIRS or infection-positive SIRS.
C07H 21/00 - Compounds containing two or more mononucleotide units having separate phosphate or polyphosphate groups linked by saccharide radicals of nucleoside groups, e.g. nucleic acids
C12Q 1/6883 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
C12Q 1/689 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for bacteria
G06F 19/20 - for hybridisation or gene expression, e.g. microarrays, sequencing by hybridisation, normalisation, profiling, noise correction models, expression ratio estimation, probe design or probe optimisation
Disclosed are method and apparatus for identifying biomarkers and in particular for identifying biomarkers for use in making clinical assessments, such as early diagnostic, diagnostic, disease stage, disease severity, disease subtype, response to therapy or prognostic assessments. In one particular example, the techniques are applied to allow assessments of patients suffering from, suspected of suffering from, or with clinical signs of SIRS (Systemic Inflammatory Response Syndrome) being either infection-negative SIRS or infection-positive SIRS.
C12Q 1/6883 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
G06F 19/20 - for hybridisation or gene expression, e.g. microarrays, sequencing by hybridisation, normalisation, profiling, noise correction models, expression ratio estimation, probe design or probe optimisation
C12Q 1/689 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for bacteria
Disclosed are methods for identifying and/or classifying microbes using one or more single nucleotide polymorphisms (SNPs) in 16S ribosomal RNA (16S rRNA) of prokaryotes and/or one or more SNPs in 5.8S ribosomal RNA (5.8S rRNA) of eukaryotes. Also disclosed are probes, primers and kits that are useful in those methods. Methods for the diagnosis of sepsis based upon these SNPs are also disclosed.
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving nucleic acids
C12Q 1/6895 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for plants, fungi or algae
G16B 30/00 - ICT specially adapted for sequence analysis involving nucleotides or amino acids
G16B 35/00 - ICT specially adapted for in silico combinatorial libraries of nucleic acids, proteins or peptides
C12Q 1/689 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for detection or identification of organisms for bacteria
05 - Pharmaceutical, veterinary and sanitary products
09 - Scientific and electric apparatus and instruments
10 - Medical apparatus and instruments
16 - Paper, cardboard and goods made from these materials
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Diagnostic preparations for medical or veterinary use;
immunological, genetic, biological, chemical and multiple
pathogen DNA test kits for medical laboratory analysis. Computer software including application forward for
conveying information in relation to medical testing and
results of medical testing; electronic publications
including in relation to medical tests and results of
medical tests; algorithms including algorithms for
diagnosing probability of having sepsis infection. Surgical and medical apparatus and instruments; apparatus
for carrying out diagnostic tests for medical purposes. Printed matter; paper based medical reports and test
results. Medical services; pathology services; medical and pathology
services in relation to medical testing for sepsis; medical
services being molecular diagnostic services; taking of body
fluid samples of others; information, advisory and
consultancy services in relation to the aforementioned.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Biological chemical test kits for medical laboratory use in
analysis of gene expression, protein expression, metabolite
impression, inflammation, immune-suppression, immune
disorders, for diagnosis and treatment of sepsis. Clinical diagnostics for medical or veterinary use;
biological chemical test kits for medical laboratory use in
analysis of gene expression, protein expression, metabolite
expression, inflammation, immune-suppression, immune
disorders. Surgical and medical apparatus and instruments; apparatus
for carrying out diagnostics tests for medical purposes;
point of care medical devices. Medical services; pathology services; medical and pathology
services being the analysis of body fluid samples; medical
services being molecular diagnostic services; taking of body
fluid samples of others; information, advisory and
consultancy services in relation to the aforementioned.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Biological chemical test kits for medical laboratory use in
analysis of gene expression, protein expression, metabolite
impression, inflammation, immune-suppression, immune
disorders, for diagnosis and treatment of sepsis. Clinical diagnostics for medical or veterinary use. Surgical and medical apparatus and instruments; apparatus
for carrying out diagnostic tests for medical purposes;
diagnostic testing kits in this class; point of care medical
devices. Medical services; pathology services; medical and pathology
services being the analysis of body fluid samples; medical
services being molecular diagnostic services; taking of body
fluid samples of others; information, advisory and
consultancy services in relation to the aforementioned.
24.
Biomarker signature method, and apparatus and kits therefor
The present invention discloses methods, kits, and apparatus as well as reagents and compositions associated therewith for deriving an indicator for use in diagnosing the presence, absence or degree of at least one condition in a biological subject or in prognosing at least one condition in a biological subject. Also disclosed is a biomarker signature for use in diagnosing the presence, absence or degree of at least one condition in a biological subject or in prognosing at least one condition in a biological subject. The present invention further discloses methods, kits and apparatus, as well as reagents and compositions associated therewith, for identifying biomarkers for use in a biomarker signature.
C12Q 1/6883 - Nucleic acid products used in the analysis of nucleic acids, e.g. primers or probes for diseases caused by alterations of genetic material
G16B 25/00 - ICT specially adapted for hybridisationICT specially adapted for gene or protein expression
G16B 40/00 - ICT specially adapted for biostatisticsICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding
25.
BIOMARKER SIGNATURE METHOD, AND APPARATUS AND KITS THEREFOR
The present invention discloses methods, kits, and apparatus as well as reagents and compositions associated therewith for deriving an indicator for use in diagnosing the presence, absence or degree of at least one condition in a biological subject or in prognosing at least one condition in a biological subject. Also disclosed is a biomarker signature for use in diagnosing the presence, absence or degree of at least one condition in a biological subject or in prognosing at least one condition in a biological subject. The present invention further discloses methods, kits and apparatus, as well as reagents and compositions associated therewith, for identifying biomarkers for use in a biomarker signature.
G06F 19/18 - for functional genomics or proteomics, e.g. genotype-phenotype associations, linkage disequilibrium, population genetics, binding site identification, mutagenesis, genotyping or genome annotation, protein-protein interactions or protein-nucleic acid interactions
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving nucleic acids
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing
26.
BIOMARKER SIGNATURE METHOD, AND APPARATUS AND KITS THEREFOR
The present invention discloses methods, kits, and apparatus as well as reagents and compositions associated therewith for deriving an indicator for use in diagnosing the presence, absence or degree of at least one condition in a biological subject or in prognosing at least one condition in a biological subject. Also disclosed is a biomarker signature for use in diagnosing the presence, absence or degree of at least one condition in a biological subject or in prognosing at least one condition in a biological subject. The present invention further discloses methods, kits and apparatus, as well as reagents and compositions associated therewith, for identifying biomarkers for use in a biomarker signature.
G06F 19/18 - for functional genomics or proteomics, e.g. genotype-phenotype associations, linkage disequilibrium, population genetics, binding site identification, mutagenesis, genotyping or genome annotation, protein-protein interactions or protein-nucleic acid interactions
C12Q 1/68 - Measuring or testing processes involving enzymes, nucleic acids or microorganismsCompositions thereforProcesses of preparing such compositions involving nucleic acids
G01N 33/50 - Chemical analysis of biological material, e.g. blood, urineTesting involving biospecific ligand binding methodsImmunological testing
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
09 - Scientific and electric apparatus and instruments
10 - Medical apparatus and instruments
16 - Paper, cardboard and goods made from these materials
42 - Scientific, technological and industrial services, research and design
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
(1) Diagnostic preparations for medical and veterinary laboratory and research use; immunological, genetic, biological, chemical and multiple pathogen DNA test kits for medical laboratory analysis
(2) Computer software namely computer software application for use in conveying information in relation to medical testing and results of medical testing; electronic publications in the field of medical tests and results of medical tests; computer software featuring algorithms for diagnosing probability of having sepsis infection
(3) Surgical instruments; medical apparatus and instruments in the field of sepsis infections; diagnostic tests for diagnosing sepsis infections; diagnostic testing kits for diagnosing sepsis infections
(4) Printed matter, namely printed publications in the field of medical testing; paper based forms for medical reports and test results (1) Medical services, namely medical diagnostic services, medical testing services, medical laboratory services, medical counselling; pathology services; medical and pathology services in relation to medical testing for sepsis; medical diagnostic services namely molecular diagnostic services; taking of body fluid samples of others for medical diagnostic purposes; information, advisory and consultancy services in the field of medicine
Disclosed are method and apparatus for identifying biomarkers and in particular for identifying biomarkers for use in making clinical assessments, such as early diagnostic, diagnostic, disease stage, disease severity, disease subtype, response to therapy or prognostic assessments. In one particular example, the techniques are applied to allow assessments of patients suffering from, suspected of suffering from, or with clinical signs of SIRS (Systemic Inflammatory Response Syndrome) being either infection-negative SIRS or infection-positive SIRS.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
42 - Scientific, technological and industrial services, research and design
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
(1) Diagnostic preparations for medical or veterinary use, namely diagnostic preparations for clinical laboratory use, for medical and veterinary laboratory use, for medical and veterinary research use, and for medical and veterinary diagnostic use; diagnostic testing kits for medical use, namely probes, buffers and reagents for use in microbial testing; biological chemical test kits for medical laboratory use in analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders, for diagnosis and treatment of sepsis
(2) Surgical instruments and medical apparatus and instruments for use in the field of sepsis infections for the analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders; diagnostic test apparatus for analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders; point of care medical devices namely devices for analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders (1) Medical services, namely medical diagnostic services, medical testing services, medical laboratory services, and medical counselling in the field of autoimmune diseases, immunologic deficiency syndromes, and sepsis; medical pathology services in the field of molecular diagnostics for and treatment of inflammation arising from infections of the blood or other infections; medical pathology services being the analysis of body fluid samples; medical services being molecular diagnostic services and taking of body fluid samples of others; providing information, advisory and consultancy services in the field of medical services for molecular diagnostics of inflammation arising from infections of the blood or other infections, and in the field of medical services for analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
42 - Scientific, technological and industrial services, research and design
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
(1) Biological chemical multiple pathogen DNA test kits for medical laboratory use; diagnostic reactants and reagents for clinical laboratory use, and for medical research use; chemical used in laboratory analysis, namely, chemical preparations consisting of pre-mixed reactants and reagents for scientific research; diagnostic preparations for medical or veterinary use, namely diagnostic preparations for medical and veterinary research use; testing kits, namely diagnostic kits consisting primarily of buffers, enzymes, binding and reporter molecules, quenchers, blocking agents, and reagents for scientific purposes for use in purification, concentration, isolation, amplification, detection, identification and quantification of microbial-specific nucleic acids or proteins or carbohydrates, or lipids or metabolites
(2) Pharmaceutical preparations and substances to facilitate multiple pathogen DNA tests, namely multiple pathogen DNA test kits for medical laboratory analysis; diagnostic preparations for medical or veterinary use, namely diagnostic preparations for clinical laboratory use, for medical and veterinary laboratory use, and for medical and veterinary diagnostic use; diagnostic reactants and reagents for medical diagnostic use
(3) Surgical and medical apparatus and instruments including for use in relation to multiple pathogen DNA tests, namely surgical instruments, and medical apparatus and instruments for use in relation to multiple pathogen DNA tests, namely, instruments or apparatus for purification, concentration, isolation, amplification, detection, identification and quantification of microbial-specific nucleic acids or proteins or carbohydrates or lipids or metabolites; testing kits, namely, diagnostic kits consisting primarily of probes for use in purification, concentration, isolation, amplification, detection, identification and quantification of microbial-specific nucleic acids or proteins or carbohydrates or lipids or metabolites; point of care medical devices namely medical instruments for analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders (1) Medical services, namely, medical laboratory research services; providing medical information, advisory and consultancy services in the field of medical laboratory research services
(2) Medical services, namely, medical diagnostic services, medical testing services, medical counselling, namely medical counseling in the field of the analysis of gene expression, protein expression, metabolite expression, inflammation, immune suppression, and immune disorders; medical pathology services, namely for the diagnosis and treatment of diseases and inflammation arising from infections of the blood or other infections, for the diagnosis and treatment of immune disorders; medical and pathology services namely the analysis of body fluid samples, molecular diagnostic services and taking of body fluid samples of others; providing medical information, advisory and consultancy services in the field of medical services, namely, medical pathology services, medical diagnostic services, medical testing services, and medical counseling in the field of the analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, and immune disorders
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
(1) Biological chemical test kits for medical laboratory use in analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders, for diagnosis and treatment of sepsis.
(2) Diagnostic preparations for medical or veterinary use, namely diagnostic preparations for clinical laboratory use, for medical and veterinary laboratory use, for medical and veterinary research use, and for medical and veterinary diagnostic use.
(3) Surgical and medical instruments for use in the field of the analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders; diagnostic test apparatus for analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders; diagnostic testing kits consisting primarily of probes, buffers and reagents for use in microbial testing; point of care medical devices namely medical instruments for the analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders.
(4) Clinical diagnostic preparations for medical or veterinary use, namely diagnostic preparations for clinical laboratory use, for medical and veterinary laboratory use, for medical and veterinary research use, and for medical and veterinary diagnostic use.
(5) Biological chemical test kits for medical laboratory use in analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders. (1) Medical services, namely, medical diagnostic services, medical testing services, medical laboratory services, and medical counseling in the field of the analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, and immune disorders; medical pathology services, namely for the analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders; medical pathology services being the analysis of body fluid samples; medical services being molecular diagnostic services and taking of body fluid samples of others; providing information, advisory and consultancy services in the field of medical services namely, medical diagnostic services, medical testing services, medical laboratory services and medical counseling in the field of the analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, and immune disorders; the analysis of body fluid samples; medical services being molecular diagnostic services and taking of body fluid samples of others.
Disclosed are methods for identifying and/or classifying microbes using one or more single nucleotide polymorphisms (SNPs) in 16S ribosomal RNA (16S rRNA) of prokaryotes and/or one or more SNPs in 5.8S ribosomal RNA (5.8S rRNA) of eukaryotes. Also disclosed are probes, primers and kits that are useful in those methods. Methods for the diagnosis of sepsis based upon these SNPs are also disclosed.
Disclosed are methods and apparatus for diagnosis, detection of host response, monitoring, treatment or management of sepsis, infection-negative systemic inflammatory response syndrome (SIRS) and post-surgical inflammation in mammals. More particularly, the present invention discloses marker genes and their splice variant transcripts as well as their expression products, which are useful for distinguishing between sepsis and infection-negative SIRS, including post-surgical inflammation, and to the use of these markers in grading, monitoring, treatment and management of these conditions.
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Clinical diagnostics for medical or veterinary use; biological chemical test kits for medical laboratory use in analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders. Surgical and medical apparatus and instruments; diagnostic tests; diagnostic testing kits in this class; point of care medical devices. Medical services; point of care medical services; pathology services; medical and pathology services being the analysis of body fluid samples; medical services being molecular diagnostic services; taking of body fluid samples of others; information, advisory and consultancy services in relation to the aforementioned.
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
Clinical diagnostics for medical or veterinary use; biological chemical test kits for medical laboratory use in analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders. Surgical and medical apparatus and instruments; diagnostic tests; diagnostic testing kits in this class; point of care medical devices. Medical services; pathology services; medical and pathology services being the analysis of body fluid samples; medical services being molecular diagnostic services; taking of body fluid samples of others; information, advisory and consultancy services in relation to the aforementioned.
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
biological chemical test kits for medical laboratory use in analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders, for diagnosis and treatment of sepsis Diagnostic preparations for medical or veterinary use [ Surgical and medical apparatus and instruments for use in analysis of gene expression, protein expression, metabolite expression, inflammation, immune- suppression, immune disorders; diagnostic test apparatus for analysis of gene expression, protein expression, metabolite expression, inflammation, immune- suppression, immune disorders; ] diagnostic testing kits in this class consisting primarily of probes, buffers and reagents for use in microbial testing [ ; point of care medical devices, namely, devices for analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders ] [ Medical services; medical pathology services; medical pathology services being the analysis body fluid samples; medical services being molecular diagnostic services and taking of body fluid samples of others; providing information, advisory and consultancy services in relation to medical services; medical pathology services; the analysis of body fluid samples; medical services being molecular diagnostic services and taking of body fluid samples of others ]
01 - Chemical and biological materials for industrial, scientific and agricultural use
05 - Pharmaceutical, veterinary and sanitary products
10 - Medical apparatus and instruments
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services
Goods & Services
biological chemical test kits for medical laboratory use in analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders, for diagnosis and treatment of sepsis Diagnostic preparations for medical or veterinary use [ Surgical and medical apparatus and instruments for use in analysis of gene expression, protein expression, metabolite expression, inflammation, immune- suppression, immune disorders; diagnostic test apparatus for analysis of gene expression, protein expression, metabolite expression, inflammation, immune- suppression, immune disorders; ] diagnostic testing kits in this class consisting primarily of probes, buffers and reagents for use in microbial testing [ ; point of care medical devices, namely, devices for analysis of gene expression, protein expression, metabolite expression, inflammation, immune-suppression, immune disorders ] [ Medical services; medical pathology services; medical pathology services being the analysis body fluid samples; medical services being molecular diagnostic services and taking of body fluid samples of others; providing information, advisory and consultancy services in relation to medical services; medical pathology services; the analysis of body fluid samples; medical services being molecular diagnostic services and taking of body fluid samples of others ]