An FDA-cleared and CE-Marked blood test specific to detecting recent hyperglycemia, glycemic variability, and pancreatic beta-cell mass
"New Study Shows GlycoMark® Test Identifies Prediabetic Individuals with the Highest Risk of Developing Diabetes Before Symptoms Develop"
This is a non-coverage policy for the GlycoMark® assay. The assay is not considered reasonable and necessary for the management of diabetes or the prevention of diabetic complications and is NOT COVERED by Medicare.
An FDA-cleared blood test specific to detecting recent hyperglycemia and hyperglycemic excursions (occurring in the fasting state, postprandial, or both).
Reveals recent trends toward or away from A1C goals, suggesting improving or worsening control.
Is Independently associated with increased rates of diabetes complications.
When used with A1C, provides a more complete assessment of glycemic control to identify patients that may benefit from closer diabetes management.
New studies show GlycoMark is a biomarker of functional pancreatic beta-cell mass in patients at risk for diabetes.