IP Library Granted Patent US 10,591,489
Granted Patent B2
US 10,591,489 · App. 15/782,595 · Granted Mar 17, 2020

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 10,591,489
App. No.
15/782,595
Granted
Mar 17, 2020
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 accompanied by chronic inflammation characterized by a dominance of T-cells of the Th1 subtype with increased expression of Tbet and Interferon gamma and/or increased Interferon gamma release, in combination with a relative absence of Th2-driven inflammatory features such as GATA-3 expression, expression and/or release of IL-4, IL-5 and IL-13 and accumulation of eosinophil granulocytes by identifying a molecular phenotype of the patient wherein the molecular phenotype is selected from the group consisting of the subgroups “Th1 high” and “Th1 low” and the gene expression of GATA-3 and/or Tbet is measured in a biological isolate of the patient and used for the assignment to a molecular phenotype of the illness wherein a therapeutic agent for downregulating Tbet expression is administered when the patient has a molecular phenotype of Th1 high and a therapeutic agent for downregulating the effects of GATA 3 is administered when the patient has a molecular phenotype of Th1 low.

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

the expression level of GATA-3 and/or Tbet is determined via the protein or mRNA quantity, wherein the protein quantity is quantitatively determined with the help of an immunoassay, preferably an ELISA test, a radioimmunoassay, an electrochemiluminescence immunoassay, a CLIA (chemoluminescence-linked immunosorbent assay), an FLIA (fluorescence-linked immunosorbent assay) or a multiplex-assay; and/or

the expression level of GATA-3 and/or Tbet is determined via the protein or mRNA quantity, wherein the mRNA quantity is quantitatively determined in particular with the help of a PCR or a micro-array chip.

3. The method according to claim 1 , characterized in that an assignment of the patient to a molecular phenotype of the subgroup “Th1 high” occurs when at least one of the following conditions is fulfilled:

the Tbet gene expression in the biological isolate is higher than a defined reference value,

the ratio of Tbet:GATA-3 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 “Th1 low” occurs when at least one of the following conditions is fulfilled:

the Tbet gene expression in the biological isolate is lower than a defined reference value,

the ratio of Tbet:GATA-3 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.

Assignments (2)
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 Oct 12, 2017
From: TUROWSKA, AGNIESZKA; BILLE, JOACHIM
To: STERNA BIOLOGICALS GMBH & CO. KG
Reel/Frame 043854/0853 →
Priority Claims (1)
EP 12184500 · Sep 14, 2012 · regional
Continuity (2)
Continuation 14428043
Related Publication 20180031571A1 · Feb 1, 2018