Who Can Benefit

For patients with diabetes, our TIGAR™ Reports are used to allow your physician to fully understand how the underlying pathways are responding to your current treatment and to adjust your treatment to meet your individual requirements. In many cases, these are independent from your glucose levels. Clinical studies have shown that when your underlying metabolic markers and your HbA1c are in control, you can actually not only feel better, but have fewer setbacks, which could improve your overall heath, even in the first year of the optimal treatment regimen.

Management of Insulin Resistant or Pre-diabetes Patients

Presently, there are 86 million people in the U.S. diagnosed with prediabetes, or about 35% of U.S. adults. Less than 10% of these adults report that they have ever been told that they have prediabetes6. IR2Dx TIGAR™ analysis can uncover patients who are at high risk for diabetes, cardiovascular disease and related conditions, and guide treatment for them.

Pre-diabetes patients should be monitored regularly, typically every three to six months, to ascertain whether or not diet and exercise programs are being followed, and whether or not overall risk of disease is decreasing. If not, use of more aggressive therapeutic options should be considered.

Our markers have been extensively studied in combination and individually in thousands of early stage patients, including nearly 1,500 pre-diabetes patients in pharmaceutical trials by our licensor. In our clinical studies, low dose oral diabetes drugs reduced the level of risk of diabetes conversion or associated conditions by lowering all of our markers over the course of treatment.

The combination of markers in the IR2Dx TIGAR™ analysis uncovers patients who are at increased risk of disease. The markers also demonstrate good overall correlation with traditional glucose markers, such as HbA1c and fasting plasma glucose. The TIGAR™ markers are intended to be used with the traditional tests. In the judgment of our clinical advisors, our clinical data has consistently demonstrated that:

• Our markers collectively have a much higher level of clinical accuracy than glucose based diagnostics alone.
• Our markers provide earlier detection of degeneration of metabolic control, which in many cases is independent of glucose-related markers.
• Glucose markers often eventually demonstrate that the patient’s condition is worsening to the point of diagnosis of diabetes. However, at this point the disease is more difficult to manage and often is a chronic disease.
• The key benefit of the TIGAR™ analytical reports is the unique combination of these markers and the decision support tool algorithm. The analysis is regularly updated to reflect current clinical research.

Management of Previously Diagnosed Diabetes Patients

Today, nearly one in eight Americans (roughly 29 million), have diabetes6, and 422 million on a global basis have the disease4. If current trends continue, the number of diabetics is expected to reach over 700 million people by 2025. Type 2 diabetes mellitus is a chronic disease that has progressive morbidity ranging from neuropathy, potential loss of limbs to heart and /or kidney disease, loss of sight, arthritis, cancer and Alzheimer’s disease, and eventually, if not adequately controlled, earlier mortality3,,7. In the U.S. alone, care of currently diagnosed patients with diabetes costs $322 billion each year1.
For patients with diabetes, our TIGAR™ reports are used to:

• Assess and monitor patient response to therapeutic intervention, assisting the physician to carefully monitor underlying disease conditions
• Individualize therapeutic regimens to lower overall disease risk levels, stemming from abnormal function of the pancreatic βeta-cell, adipose tissue, and cardiovascular system