BEAVERTON, OR, United States
BEAVERTON, OR, United States

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Patent
Diabetomics, Llc | Date: 2014-10-16

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.


Methods for identifying individuals who are not yet diabetic (pre-diabetic), but who are at significant risk of developing diabetes, such as type 2 diabetes, are disclosed herein. Methods are also provided for the identification of diabetic subjects. Also disclosed are methods for identifying individuals with diabetic complications. The methods include the identification of an overall glycosylation profile of proteins in a biological fluid, such as saliva, urine, or serum. In some examples, the methods include determining the amount of one or more protein in a biological fluid or determining the glycosylation pattern of one or more proteins in a biological fluid.


Methods for identifying individuals who are not yet diabetic (pre-diabetic), but who are at significant risk of developing diabetes, such as type 2 diabetes, are disclosed herein. Methods are also provided for the identification of diabetic subjects. Also disclosed are methods for identifying individuals with diabetic complications. The methods include the identification of an overall glycosylation profile of proteins in a biological fluid, such as saliva, urine, or serum. In some examples, the methods include determining the amount of one or more protein in a biological fluid or determining the glycosylation pattern of one or more proteins in a biological fluid.


Disclosed herein are methods and tests for diagnosing and/or monitoring a metabolic condition such as diabetes in a subject, wherein the methods and tests measure salivary glycoproteins. Some of the methods are based on the oxidation of glycoproteins in a sample from the subject, such as saliva or urine, for example using sodium metaperiodate, and then detecting the aldehydes generated during oxidation using a chemical detection method. Also disclosed are kits and lateral flow devices for detecting glycoproteins in a saliva sample.


Patent
Diabetomics, Llc | Date: 2013-11-21

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.


Disclosed herein are methods and tests for diagnosing and/or monitoring a metabolic condition such as diabetes in a subject, wherein the methods and tests measure salivary glycoproteins. Some of the methods are based on the oxidation of glycoproteins in a saliva sample from the subject, for example using sodium metaperiodate, and then detecting the aldehydes generated during oxidation using a chemical detection method. Also disclosed are kits and lateral flow devices for detecting glycoproteins in a saliva sample.


Patent
Diabetomics, Llc | Date: 2014-07-25

Disclosed herein are screening tools for fetal/maternal wellness, such as biomarkers for assessing preeclampsia. More specifically, methods are disclosed for assessing the risk of preeclampsia in a subject, the methods including obtaining a first serum sample from the subject, determining a level of glycosylated fibronectin (GlyFn) in the first serum sample, and comparing the determined level of GlyFn with a control value, wherein an elevation in the determined level of GlyFn in the first serum sample relative to the control value indicates that the subject is at increased risk of preeclampsia. Also disclosed are methods of determining the risk of preeclampsia in a subject during a first, second, or third trimester, methods of assessing severity and progression of preeclampsia and complications of a risk of low birth weight or HELLP syndrome.


Methods for identifying individuals who are not yet diabetic (pre-diabetic), but who are at significant risk of developing diabetes, such as type 2 diabetes, are disclosed herein. Methods are also provided for the identification of diabetic subjects. Also disclosed are methods for identifying individuals with diabetic complications. The methods include the identification of an overall glycosylation profile of proteins in a biological fluid, such as saliva, urine, or serum. In some examples, the methods include determining the amount of one or more protein in a biological fluid or determining the glycosylation pattern of one or more proteins in a biological fluid.


Patent
Diabetomics, Llc | Date: 2013-03-11

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.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 582.75K | Year: 2012

DESCRIPTION (provided by applicant): The presence of islet-directed auto-immunity and associated circulating auto-antibodies, previously thought to be primarily characteristic of type-1 diabetes mellitus (T1DM), is now apparent in a proportion of individuals with putative type-2 diabetes (T2DM), consistent with an increasing appreciation of diabetes as a continuous spectrum. Based on the observations that: 1) gt98 percent of new-onset cases of T1DM have one or more auto-antibodies; 2) the number of auto-antibodies is proportional to risk of developing T1DM, with any one corresponding to an almost 30-fold increase in risk; 3) the presence of auto-antibodies in adolescents with apparent T2DM defines a distinct patient group that may require different treatment regimens; and 4) the presence of auto-antibodies in adults with presumed T2DM can indicate a more rapid progression to insulin dependency, increased screening for autoantibody status in diabetic and pre-diabetic populations is warranted. The major hurdle for reaching the large at-risk population is the lack of a simple-to-use, point-of-car device to rapidly screen for diabetes autoimmune status. The extension of accurate autoantibody detection to alternative body fluids can facilitate the accessibilityof this importan diagnostic parameter to at-risk patient groups for more cost-effective and efficient disease detection and monitoring. Our preliminary data support the hypothesis that diabetes auto-antibodies can be reliably assessed in saliva and that their detection is amenable to simple point- of-care, device-based technologies. To demonstrate the utility of this approach, we will pursue the following two Specific Aims in this phase-I application. Specific aim 1: Correlation of autoantibody status in matched serum and saliva samples in classical T1DM and in T2DM. Specific aim 2: Development of a non-invasive, saliva-based, lateral-flow device for detection of autoimmune diabetes. The proposed research, by developing new methods and technologies able to identify individuals at risk of developing type-1 diabetes with a specific focus on point-f-care assays, low-cost/portable devices, non-invasive testing, and assessment of immune status, is directly relevant to the goals of RFA-DK-11-024 and many of the relevant topics described therein. PUBLIC HEALTH RELEVANCE: The incidence of diabetes is reaching epidemic proportions in the US and the world at large, with projected massive increases in the number of individuals with additional serious complications such as heart, kidney, and eye disease and cognitive decline. A significant problem is the lack of a simple, inexpensive, and convenient approach to detect persons with autoimmune diabetes. The ability to easily identify people that may be at riskfor the development of autoimmune diabetes is critical to prevent acute, life-threatening conditions as well as to institute measures to delay or prevent the progression of the disease. The research proposed in this application will investigate the feasibility of measuring antibodies that reflect the risk of diabetes in saliva rather than in blood, and develop a simple non-invasive test device similar to a home pregnancy test that will be suitable for medical office, home, and field use to determine if onehas the auto-antibodies that are associated with diabetes risk.

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