Adding tests that help your physicians manage chronic diseases that are growing exponentially, such as diabetes, are good for patients, physicians and business.  Here are the facts from the American Diabetes Association:

• In 2011, more than 25.8 million people in the U.S. had diabetes (8.3% of the population)
• Nearly 2 million are diagnosed with diabetes each year
• 7 million are undiagnosed and 79 million (25% of the population) have pre-diabetes
• Complications are numerous and costly including cardiovascular disease and stroke, blindness, kidney disease and amputations

Source: http://www.diabetes.org/diabetes-basics/diabetes-statistics/

Offering the GlycoMark test as a reflex test when A1Cs are between 6.0% - 8.0% makes it easy for your doctors to order the test and approximately 25%-30% of all A1Cs fall in this range.   Offering the GlycoMark test as an individual test also offers your doctors a chance to monitor glycemic control more frequently than the A1C test which is limited to 3-4 times per year.

The GlycoMark test is not offered at every reference lab in the country.  Offering the test to your physicians demonstrates you are on the cutting edge of diagnostic care.  What clinicians may be most interested in the GlycoMark test?

• Family Practice (MD, DO, NP, PA)
• Internal Medicine (MD, DO, NP, PA)
• Endocrinologists and Diabetologists
• Certified Diabetes Educators (NPs)
• Cardiologists providing primary care and diabetes management services
• OB/GYNs providing primary care and diabetes management services

• An FDA-cleared, CE-marked, nonfasting serum or plasma test for monitoring people with diabetes, providing information on glucose variability not evident with hemoglobin A1C (due to the biological differences between the GlycoMark test and hemoglobin A1C).
• The GlycoMark blood test measures 1,5-AG (anhydroglucitol) –  a sugar similar to glucose.
• When hyperglycemia over 180 mg/dL occurs, 1,5-AG is excreted in the urine and the serum 1,5-AG level decreases quickly.
• When A1C is ≤8%, GlycoMark values<10 µg/mL reveal significant glucose variability.

• Patients often do not provide critical postmeal blood glucose data so that doctors have more information to safely adjust or add the correct diabetes medications.
• Over-titration of some diabetes medications can cause dangerously low blood glucose (hypoglycemia).
• Using a marker to identify recent hyperglycemia can give physicians insight as to which medication to adjust – fasting or prandial (meal-related) – and can help physicians more safely personalize therapy to achieve A1Cs below target (6.5%-7%).
• The DCCT and UKPDS studies showed every 1% reduction in HbA1C significantly reduced eye, kidney and nerve damage.
• Like A1C, the 1,5-AG marker has been linked to higher risk of the following:
• Retinopathy (eye disease)
• Nephropathy (kidney disease)
• Stroke and Coronary Heart Disease
• Macrosomia  - high birth weight babies
• The GlycoMark test is not affected by hemoglobinopathies, such as anemias and malaria.
• The GlycoMark test can also be used as a shorter term marker at all levels of A1C.

The GlycoMark test is easy to implement in your lab, and we will help you with every step.

• The GlycoMark test is a two-step enzymatic assay that can be run on most open chemistry analyzers in about ten minutes.  Ask us for the settings parameters for your chemistry analyzer.
• We provide controls, calibration and reagent kits for your initial validation studies.                      
• The GlycoMark test is categorized as a moderate complexity test under CLIA when used with the Hitachi analyzer.  Consult your regulatory consultant about CLIA categorization for a different chemistry analyzer.
• Reference range, precision, linearity and interference testing were done in the following study:

Clinica Chimica Acta 2004 350 201–209 – Nowatzke, et al.
Evaluation of an assay for serum 1,5-anhydroglucitol (GlycoMark) and determination of reference intervals on the Hitachi 917 analyzer