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Publication Number
US-8852873-B2
Publication Date
2014-10-07
Expiration Date
Abstract
Embodiments herein relate to the field of screening tools for fetal/maternal wellness, and, more specifically, to biomarkers for gestational diabetes. In various embodiments, the methods may provide non-invasive and minimally-invasive screening tools for gestational diabetes that involve detection of changes in a proteomic profile of a test sample relative to a reference sample. In particular embodiments, the method may include determining whether a proteomic profile of a test sample from the subject includes at least one expression signature characteristic of gestational diabetes, wherein the proteomic profile comprises information on the expression of glycosylated fibronectin and glycosylated PSG, for example information on levels of fibronectin-SNA or a fibronectin-antibody complex, and PSG-AAL or a PSG-antibody complex. In some embodiments, the proteomic profile may also include information on the expression of adiponectin, sex hormone binding globulin (SHBG), C-reactive protein (CRP), a ratio of human chorionic gonadotropin (hCG) to placental lactogen, or a combination thereof.
Core Innovation
The disclosure relates to non-invasive or minimally invasive screening for gestational diabetes mellitus in a subject using a proteomic expression signature obtained from maternal samples. The screening is based on glycosylated fibronectin detected by fibronectin-SNA or by a fibronectin-antibody complex, and glycosylated pregnancy-specific glycoprotein (PSG) detected by PSG-AAL or by a PSG-antibody complex.
The disclosed proteomic approach further considers additional biomarkers in the proteomic profile, including adiponectin, sex hormone binding globulin (SHBG), C-reactive protein (CRP), and an hCG/placental lactogen ratio. The content describes cohort studies in which OGTT-confirmed GDM is used to evaluate the measured signatures, with reported elevations of PSG-AAL, fibronectin-SNA, and the hCG/placental lactogen ratio.
The disclosure states that discrimination for gestational diabetes can be improved using multi-analyte models, including reported AUROC improvements compared with other models. It also discusses assay platforms compatible with the screening, including ELISA, protein arrays and proteomics, dried blood spot compatibility, and an example lateral flow immunoassay for fibronectin (FN-LFIA) with reported concordance to fibronectin ELISA.
Claims Coverage
The partial content identifies two independent claims directed to gestational diabetes screening kits. The main inventive features correspond to the kit antibody compositions, including specific lectin-defined anti-fibronectin-SNA and anti-PSG-AAL antibodies, with optional expansion to additional pregnancy- and inflammation-related antibody targets.
Lectin-defined anti-fibronectin-SNA and anti-PSG-AAL antibody kit
A kit for screening for gestational diabetes in a subject comprising an anti-fibronectin-SNA (Sambucus nigra lectin) antibody and an anti-PSG-AAL (pregnancy-specific glycoprotein-Aleuria aurantia lectin) antibody.
Multi-antibody gestational diabetes screening kit for pregnancy and inflammation targets
A kit for screening for gestational diabetes in a subject comprising an anti-fibronectin-SNA antibody or an anti-fibronectin antibody; an anti-PSG-AAL antibody or an anti-PSG antibody; an anti-adiponectin antibody; an anti-sex hormone binding globulin (SHBG) antibody; an anti-C-reactive protein (CRP) antibody; an anti-human chorionic gonadotropin (hCG) antibody; and an anti-placental lactogen antibody.
Across the independent claims, the kit is centered on antibody components for glycosylated fibronectin (via fibronectin-SNA and/or anti-fibronectin) and glycosylated PSG (via PSG-AAL and/or anti-PSG), and in one independent claim expands to a defined panel including adiponectin, SHBG, CRP, hCG, and placental lactogen.
Stated Advantages
Improved discrimination for gestational diabetes using multi-analyte models, including reported AUROC improvements.
Reported concordance of an example lateral flow immunoassay for fibronectin (FN-LFIA) with fibronectin ELISA.
Documented Applications
Screening for gestational diabetes in a subject using maternal samples and proteomic expression signatures based on glycosylated fibronectin and glycosylated PSG.
Use of assay platforms for the screening, including ELISA, protein arrays and proteomics approaches, dried blood spot compatibility, and an example lateral flow immunoassay (FN-LFIA) for fibronectin.
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