The Epinex G1A Test for Diabetes Monitoring

Epinex market research has identified markets of more than 13 million diabetics in the U.S. alone who would immediately benefit from the G1A™ Rapid Diabetes Monitoring Index Test.

* This product is under development, and is intended for information and evaluation process only. It is NOT APPROVED by the FDA.


Gestational Diabetes (GDM)

  • 3.4 million pregnancies/year; 135,000 cases of GDM/year.

  • Medical authorities call for ALL pregnant women to be screened for GDM.

  • Rapid test for short-term glycation currently does not exist.

  • Point-of-Care Symposium recommends glycated albumin as the test of choice for GDM.

  • G1A™ is a tool to screen all expectant mothers and monitor GDM.

Diabetics on Hemodialysis

  • Approximately 200,000 diabetics are on hemodialysis.

  • Diabetes is the leading cause of end-stage renal disease (ESRD).

  • Hemodialysis drug interactions cause HbA1c test to yield questionable results.

  • Glycated albumin is a more accurate measure of glycation.

  • G1A™ testing will more accurately reflect glycemic control.

Red Cell Disorders (hemoglobinopathy)

  • Approximately 560,000 type 2 diabetics suffer from red blood cell disorders.

  • Because of its dependence on red blood cells, HbA1c can yield false high/low results with potential for misdiagnosis or under treatment.

  • The G1A™ test measures glycated albumin, which is unaffected by RBC disorders.

Geriatric patients and diabetes

  • Approximately nine million diabetics are over 65.

  • Diabetes is the 6th most common cause of death among the elderly.

  • Most do not meet short-term glucose goals.

  • The monthly G1A™ test is an early intervention tool that can improve compliance and quality of life.


The G1A™ test has the potential to benefit ALL diabetics.


 Type 2 Diabetics

  • Integrate the G1A™ monthly test for glycation into corporate and community wellness and consultation programs.

  • Accounts for approximately 90-95% of the diabetes market.

  • Studies have shown that frequent blood glucose testing is not associated with improved glycemic control in type 2 diabetics and may result in decreased quality of life with higher levels of frustration, worries, and depression.

  • Physicians would decrease or eliminate daily blood glucose testing for type 2 diabetics if monthly glycation monitoring, such as the G1A™ test, were available (Epinex survey of endocrinologists).

  • Potential overall healthcare savings of $1 billion or more.

Screening For Pre-Diabetes and Metabolic Syndrome

  • G1A™ monthly testing would allow early detection of dangerous increases in glycation and enables lifestyle modification and prevention before the development of disease and its related complications.

  • Has a market of as many as 54 million people in the U.S.

  • Affects the overweight, elderly, and people with a family history of diabetes.

  • Can decrease the prevalence of worldwide diabetes .

Coronary Artery Disease

  • Clinical studies in 2007 found “a strong and specific connection or association between elevated glycated albumin levels and coronary disease, with no correlation to HbA1c levels.”

  • Approximately 9.8 million people in the US suffer chest pain due to narrowing of coronary arteries.

  • Coronary heart disease is the single leading cause of death in America.

  • G1A™ test could provide a useful marker for predicting the onset of coronary artery disease in people with type 2 diabetes.

Diabetes Drug Trials

The FDA has recommended that new drug therapies for type 2 diabetes provide evidence that therapy will not increase the risk of cardiovascular disease. The G1A™ test could be used as a cardiovascular disease marker during phase II and phase III clinical trials.