MARKET-THE EPINEX G1A TEST FOR DIABETES MONITORING

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.

IMMEDIATE TARGET MARKETS FOR THE G1A TEST

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.

FUTURE MARKETS

 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.