Mellitus is developing the GCD59 Test, an in vitro diagnostic test for diabetes detection and monitoring based on research conducted by scientific co-founders Jose A. Halperin, M.D., and Michael Chorev, Ph.D., Associate Professors of Medicine at Brigham & Women’s Hospital and at Harvard Medical School.
Glycated CD59 (GCD59) is a novel biomarker for diabetes because of its unique characteristics of having the ability to assess glycemic control and a direct relationship with the complications of diabetes such as nephropathy, neuropathy and retinopathy.
The GCD59 Test is a sensitive and specific enzyme-linked immunosorbent assay (ELISA) that measures GCD59 levels in plasma. Levels of GCD59 are known to be significantly elevated in individuals with diabetes.
The first indication for the test will be a convenient, more patient-friendly method of identifying the potential risk of GDM in pregnant women, a major public health priority worldwide. Mellitus intends to seek FDA de novo 510(k) clearance for the GCD59 Test.
GDM also known as diabetes in pregnancy, is a major cause of adverse pregnancy outcomes for both babies and mothers. Approximately four million pregnant women are screened for GDM each year in the United States alone. Because treatment of GDM mitigates the risk of complications, practice guidelines from professional organizations such as the American College of Obstetrics and Gynecology and the American Diabetes Association recommend screening of all non-diabetic pregnant women for GDM. Current standard-of-care tests for the screening and diagnosis of GDM are time consuming, uncomfortable for the patients and are reported to have poor reproducibility, highlighting the need for an accurate, simpler and more patient-friendly test for GDM.