IP Library Granted Patent US 9,791,454
Granted Patent B2
US 9,791,454 · App. 14/428,043 · Granted Oct 17, 2017

Method for diagnosing a molecular phenotype of a patient suffering from an illness accompanied by chronic inflammation

Inventors: Agnieszka Turowska (Giessen, DE); Joachim Bille (Reiskirchen, DE)
Assignee: STERNA BIOLOGICALS GMBH & CO. KG
G01N33/6872C12N15/113G01N33/6893C12N2310/127C12N2320/30G01N2333/4703G01N2333/4706G01N2800/52G01N2800/7095
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Quick Facts
Patent No.
US 9,791,454
App. No.
14/428,043
Granted
Oct 17, 2017
Kind
B2
Abstract

Chronic inflammation is an increasing medical problem area of high socioeconomic significance. The invention relates to a method and a kit for diagnosing a molecular phenotype of a patient suffering from an illness accompanied by chronic inflammation, and to a medicament for treating such a patient. To that end, the gene expression of GATA-3 and/or Tbet in a biological isolate of the patient is measured and used for association with a molecular phenotype of the illness.

Claims (11)

1. A method for diagnosing and treating chronic inflammation in a patient suffering from an illness associated with chronic inflammation, by identifying a molecular phenotype of the patient wherein the molecular phenotype is selected from the group consisting of the subgroups “Th2 high”, and “Th2 low” and the gene expression of Th2 cell-specific transcription factor (GATA-3) and/or the Th1 cell-specific transcription factor (Tbet) is measured in a biological isolate of the patient and used for the assignment to a molecular phenotype of the illness wherein the expression level of GATA-3 and/or Tbet is determined via the protein or mRNA quantity, and wherein the protein quantity is quantitatively determined by an immunoassay and wherein a therapeutic agent effective for specifically inhibiting GATA-3 or Tbet expression according to the identified molecular phenotype is administered to the patient.

2. The method according to claim 1 , characterized in that

the immunoassay is selected from the group consisting of an ELISA test, a radioimmunoassay, an electrochemiluminescence immunoassay, a CLIA (chemoluminescence-linked immunosorbent assay), an FLIA (fluorescence-linked immunosorbent assay) and a multiplex-assay.

3. The method according to claim 1 , characterized in that an assignment of the patient to a molecular phenotype of the subgroup “Th2 high” occurs when at least one of the following conditions is fulfilled:

the GATA-3gene expression in the biological isolate is higher than a defined reference value

the ratio of GATA-3 : Tbet gene expression in the biological isolate is higher than a defined reference value.

4. The method according to claim 1 , characterized in that an assignment of the patient to a molecular phenotype of the subgroup “Th2 low” occurs when at least one of the following conditions is fulfilled:

the GATA-3 gene expression in the biological isolate is lower than a defined reference value,

the ratio of GATA-3 : Tbet gene expression in the biological isolate is lower than a defined reference value.

5. The method according to claim 1 , characterized in that along with the determination of the gene expression of GATA-3 and/or Tbet a determination of the serum IgE level and/or the number of eosinophilic granulocytes occurs and/or the Fe NO value is determined.

6. The method according to claim 1 , characterized in that the illness accompanied by chronic inflammations is Th2-induced, such as for example allergic bronchial asthma, rhinoconjunctivitis, allergic sinusitis, atopical dermatitis, food allergies, pemphigus, ulcerative colitzis, parasitic illnesses, or Th1-induced, such as for example psoriasis, allergic contact eczema, Crohn's disease, COPD, rheumatoid arthritis, autoimmune diseases, type 1 diabetes mellitus or MS.

Assignments (3)
CHANGE OF NAME Recorded Jun 6, 2023
From: STERNA BIOLOGICALS GMBH & CO. KG
To: STERNA BIOLOGICALS GMBH
Reel/Frame 063881/0972 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 3, 2017
From: TUROWSKA, AGNIESZKA; BILLE, JOACHIM
To: STERNA BIOLOGICALS GMBH & CO. KG
Reel/Frame 043191/0676 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 7, 2015
From: TUROWSKA, AGNIESZKA; BILLE, JOACHIM
To: STERNA BIOLOGICALS GMBH & CO. KG BIOMEDIZINISCHES FORSCHUNGSZENTRUM
Reel/Frame 035588/0315 →
Priority Claims (1)
EP 12184500 · Sep 14, 2012 · regional
Continuity (1)
Related Publication 20150260728A1 · Sep 17, 2015