Our Approach to Testing

IR2Dx is the leading company to demonstrate the clinical value of combining the specific biomarkers and descriptors in a single diagnostic assessment, giving valuable information on the patient’s underlying metabolic state, and linking it to treatment selection and monitoring.

Overview

IR2Dx has developed and validated biomarkers with patient descriptors that can be analyzed in our TIGAR™ Report. This analysis may be used to assist physicians and clinicians in assessing and classifying patients, to aid in treatment selection at any stage of disease, and to facilitate monitoring the treatment of patients who already have Type 2 diabetes mellitus. All tests utilized in the analysis are protein immunoassays and other well-proven methods.

The information focuses on these major areas:

  1. Insulin resistance
  2. Insulin insufficiency
  3. Beta-cell stress and function
  4. Adipose tissue activity
  5. Cardiovascular inflammation
  6. Stage of pharmaceutical therapy
  7. Average blood glucose levels
  8. Renal function

Our company has studied more than 14,000 patients in multiple pharmaceutical drug interventional clinical studies

  • These studies included patients with various stages of diabetes, demonstrating the value of using TIGAR™ markers in addition to typical current diagnostic workups, which generally focus on circulating glucose levels, BMI, lipids and other related factors like hypertension.
  • The trials primarily focus on patients who already have Type 2 diabetes mellitus and who are treated with a number of different anti-diabetic drugs – ranging from first line monotherapy with metformin or sulfonylureas, all the way to insulin formulations, and nearly every oral and/or subcutaneous anti-diabetic medication.
  • Our markers have good concordance with standard glucose-related markers, but in many cases provide independent information on the patient’s condition, with whatever regimen they are using. In numerous cases, improvement in our markers was later validated by HbA1c, but at a much later date.

The markers used in our analytical reports demonstrate added value to the standard tests, such as HbA1c, in their ability to show earlier signals of insulin resistance and beta-cell stress in pre-diabetes patients. Our clinical studies include 1,500 pre-diabetes patients in multiple drug interventional trials. Specifically, our TIGAR™ markers, such as adiponectin, intact proinsulin and hsCRP, demonstrate that while many of these high risk patients do not yet have diabetes, according to conventional glucose tests like HbA1c, they no longer have proper metabolic control. The remaining four biomarkers used in the TIGAR™ Report include insulin, C-peptide, HbA1c and estimated GFR (Glomerular Filtration Rate). The precise diagnostic information from the IR2Dx reports enables a clinician to administer, assess, and monitor personalized therapy much more effectively than the individual glucose related tests used in current practice. Please see the patient example charts displaying the effects of selected major classes of anti-diabetics on the IR2Dx TIGAR™ markers, as compared with traditional glucose tests, and the way TIGAR™ was useful in actual patients.

To augment your diagnostic resources in patient management, we have laboratory partners that cover your geographical area with the TIGAR™ analytical reports under license from IR2Dx. We will provide access through a proprietary website portal to assist you in using our reports and the individual marker levels included in them.

To view IR2Dx’s clinical studies mentioned above, please see our publications and abstracts where you’ll be able to sort by, among other items, biomarkers or date of publication.