Biomarkers for prenatal diagnosis of congenital cytomegalovirus
AssigneeThe Regents of the University of California
InventorsLenore Pereira, Ekaterina Maidji, Takako Tabata, Susan Jane McDonagh
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Abstract
The invention provides compositions and methods useful for early detection of congenital CMV infection, predicting the likelihood and severity of congenital CMV disease, and monitoring the efficacy of therapeutic approaches. Compositions of the present invention include biomarkers that are differentially expressed in CMV-infected mothers and fetuses compared to uninfected individuals.
Claims24
A method of diagnosing congenital cytomegalovirus (CMV) infection, the method comprising the steps of:
- (a) obtaining a biological sample from a subject;
- (b) contacting the biological sample with reagents that specifically bind to at least one CMV-associated marker selected from the group consisting of:
- Fms-like tyrosine kinase-1 (Flt-1;
- VEGFR-1), soluble Flt-1 (sFlt-1), vascular endothelial growth factor A (VEGF-A), placental growth factor (PlGF), CXC ligand-12 (CXCL-12;
- SDF-1), suppressor of cytokine signaling 3 (SOCS3), erythropoietin;
- transferrin, transforming growth factor (TGF) beta 3, TGF beta 1, endoglin, soluble endoglin (sEng), carcinoembryonic antigen-related cell adhesion molecule 1 (CEACAM1), IL-1 beta, IL-6, IL-8, IL-10, cmvIL-10, CMV ORF UL146 (v-CXC-1), integrin αvβ6, ITGB6, ALK1, ALK5, and pUS22;
- (c) determining whether the marker is differentially expressed in the biological sample compared to a biological sample from a non-infected subject;
- thereby providing a diagnosis for congenital CMV infection.
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A method of predicting congenital cytomegalovirus (CMV) disease, the method comprising the steps of:
- (a) obtaining a biological sample from a subject;
- (b) contacting the biological sample with reagents that specifically bind to at least one CMV-associated marker selected from the group consisting of:
- Fms-like tyrosine kinase-1 (Flt-1;
- VEGFR-1), sFlt-1, vascular endothelial growth factor A (VEGF-A), placental growth factor (PlGF), CXC ligand-12 (CXCL-12, SDF-1), suppressor of cytokine signaling 3 (SOCS3), erythropoietin;
- transferrin, TGF beta 3, TGF beta 1, endoglin, soluble endoglin (sEng), CEACAM1, IL-1 beta, IL-6, IL-8, IL-10, cmvIL-10, CMV ORF UL146 (v-CXC-1), integrin αvβ6, ITGB6, ALK1, ALK5, and pUS22;
- (c) determining whether the marker is differentially expressed in the biological sample compared to a biological sample from a non-infected subject;
- thereby predicting congenital CMV disease.
A method of determining the efficacy of therapy for congenital cytomegalovirus (CMV) infection, the method comprising the steps of:
- (a) obtaining a biological sample from a subject;
- (b) contacting the biological sample with reagents that specifically bind to at least one CMV-associated marker selected from the group consisting of:
- Fms-like tyrosine kinase-1 (Flt-1;
- VEGFR-1), sFlt-1, vascular endothelial growth factor A (VEGF-A), placental growth factor (PlGF), CXC ligand-12 (CXCL-12, SDF-1), suppressor of cytokine signaling 3 (SOCS3), erythropoietin;
- transferrin, TGF beta 3, TGF beta 1, endoglin, soluble endoglin (sEng), CEACAM1, IL-1 beta, IL-6, IL-8, IL-10, cmvIL-10, CMV ORF UL146 (v-CXC-1), integrin αvβ6, ITGB6, ALK1, ALK5, and pUS22;
- (c) determining whether the marker is differentially expressed in the biological sample compared to a biological sample obtained from the subject at an earlier time;
- thereby determining the efficacy of therapy.
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A method of diagnosing congenital cytomegalovirus (CMV) infection or disease, the method comprising the steps of:
- (a) obtaining a biological sample from a subject;
- (b) determining the level of phosphorylation of at least one CMV-associated marker selected from Smad3, Smad1, and Smad5;
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- (c) determining whether the marker is differentially phosphorylated in the biological sample as compared to a biological sample from a non-infected or non-diseased subject;
- thereby providing a diagnosis for congenital CMV infection or disease.
A kit comprising reagents that specifically bind to a panel of CMV-associated markers, wherein the kit comprises one or more reagents that bind to one or more markers selected from the group consisting of Fms-like tyrosine kinase-1 (Flt-1;
- VEGFR-1), sFlt-1, vascular endothelial growth factor A (VEGF-A), placental growth factor (PlGF), CXC ligand-12 (CXCL-12, SDF-1), suppressor of cytokine signaling 3 (SOCS3), erythropoietin;
- transferrin, TGF beta 3, TGF beta 1, endoglin, soluble endoglin (sEng), CEACAM1, IL-1 beta, IL-6, IL-8, IL-10, cmvIL-10, CMV ORF UL146 (v-CXC-1), integrin αvβ6, ITGB6, ALK1, ALK5, Smad3, and pUS22.
Dependencies are inferred from the claim text.