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Maternal serum biomarkers for risk assessment in gestational diabetes. A potential universal screening test to
Srinivasa R Nagalla1, Caryn K Snyder1, John E Michaels1
1DiabetOmics Inc, Beaverton, Oregon, USA.
Insights
A new maternal serum test shows promise for screening gestational diabetes mellitus (GDM). This multi-analyte panel detects 87% of GDM cases with a 1% false-positive rate, offering a potential improvement over current methods.
Area of Science:
- Biochemistry
- Clinical Diagnostics
- Reproductive Medicine
Background:
- Gestational diabetes mellitus (GDM) prevalence is rising globally, linked to the obesity and diabetes epidemic.
- Untreated GDM poses risks to both mother and child, including pregnancy complications and future type-2 diabetes.
- Current GDM screening via oral glucose tolerance tests are invasive and not widely accessible.
Purpose of the Study:
- To develop and evaluate a novel multi-analyte maternal serum profile test for GDM screening.
- To incorporate novel glycoprotein biomarkers alongside established GDM-associated markers.
Main Methods:
- Development of a multi-analyte maternal serum profile test.
- Inclusion of novel glycoprotein biomarkers and previously described GDM markers.
- Evaluation of the test's performance in screening for GDM.
Main Results:
- The multi-analyte panel achieved an 87% detection rate for GDM.
- The test demonstrated a low false-positive rate of 1%.
Conclusions:
- The developed multi-analyte serum profile test shows significant potential for accurate and accessible GDM screening.
- This novel biomarker panel may offer a more efficient alternative to traditional GDM testing methods.
Abstract:
The prevalence of gestational diabetes mellitus (GDM) is increasing because of the worldwide obesity/diabetes epidemic. The complications of untreated GDM affect both the mother and baby and include complications during pregnancy as well as increased risk of subsequent type-2 diabetes in mothers and offspring. Standard tests for hyperglycemia in diabetes, such as fasting glucose and hemoglobin (HbA1c), are currently not recommended for GDM screening. Instead, an oral glucose tolerance test is specified, which is invasive, time-consuming, and not easily accessible to many at-risk populations. In this study, we describe a multi-analyte maternal serum profile test that incorporates novel glycoprotein biomarkers and previously described GDM-associated markers. In screening for GDM by multi-analyte panel, the detection rate was 87% at a false-positive rate of 1%.
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