Researchers Studying Novel Gestational Diabetes Screening Alternative

Researchers at Brigham and Women’s Hospital (BWH) recently published a study demonstrating the potential clinical utility of glycated CD59 (GCD59) as a novel biomarker for the screening and diagnosis of gestational diabetes mellitus (GDM). The data from this study showed that a single blood test that measures plasma GCD59 at week 24-28 of gestation identified women with GDM with high sensitivity and specificity. The paper was published in Diabetes Care.

The study was completed by a team of investigators at BWH led by Jose A. Halperin, MD, associate professor of Medicine at Harvard Medical School in collaboration with researchers from Harvard T.H. Chan School of Public Health. Halperin is also the scientific co-founder of Mellitus – a company dedicated to advancing diabetes detection.

The protein known as CD59 is an inhibitor of the complement system that is inactivated by high glucose in diabetes to form glycated CD59 (GCD59). Inactivation of CD59 decreases its protective effect and promotes complement-mediated damage that reportedly plays a role in the processes leading to complications of diabetes such as nephropathy, neuropathy and retinopathy.

Researchers evaluated levels of GCD59 in plasma samples from 1,000 women undergoing routine screening and diagnosis of GDM at week 24-28 of gestation at Brigham and Women’s Hospital in Boston. Five hundred of the samples were from women who had a normal GCT (controls) and another 500 were from women who had failed the GCT and completed a subsequent OGTT (cases). Of the cases, 127 were diagnosed with GDM. The primary objective of the study was to assess the accuracy of plasma GCD59 to predict the results of the GCT. Secondary aims were to assess the accuracy of plasma GCD59 in predicting the diagnosis of GDM by OGTT and the association of plasma GCD59 with the prevalence of LGA newborns.

The study found that, compared to controls, median levels of plasma GCD59 were 8.5-fold higher in women who failed the GCT and 10-fold higher in women diagnosed with GDM. Results also demonstrated that measurement of plasma GCD59 independently discriminated cases from controls with high sensitivity and specificity, even after adjustment for covariates such as maternal age, BMI, race/ethnicity, multiplicity, gestational age and previous history of diabetes.

An exclusive, worldwide license agreement with Harvard University covers Mellitus’ development of the GCD59 technology for diagnostic applications and related therapeutics.

“The planned development of the GCD59 test by Mellitus supports our mission to foster innovation and collaborate with industry to translate new discoveries made at Harvard into useful products that are beneficial to society,” says Isaac T. Kohlberg, senior associate provost and chief technology development officer at Harvard University.

“This is the first study to demonstrate that a single measurement of plasma GCD59 can be used as a simplified method to identify women who would have failed a GCT and are at higher risk of GDM,” says  Halperin. “These results indicate that measurement of this novel disease-associated biomarker may be a convenient and effective alternative to the cumbersome methods currently used to screen and diagnose GDM; the study opens the door to future multi-center studies to confirm the clinical utility of plasma GCD59 as a biomarker for detection and diagnosis of GDM.”