IR2Dx’s initial product, the TIGAR™ Report, is focused on measurement of underlying pathway function, followed by assessment of the pattern of results along with other patient demographic and biochemical parameters, with linkage to mechanisms and effects of anti-diabetic drug classes. The key benefit of the markers in the TIGAR™ Report is the information from the unique combination of these markers and the proprietary analysis.
The assays are easy to run in clinical laboratories with standard equipment:
- All of the assays are currently available from various diagnostic companies for clinical laboratory use.
- Most of the tests are immunoassays that use specific pairs of monoclonal antibodies in a sandwich assay format.
- •Licensed partners and users will have access to a proprietary web-based portal that will provide analysis and reports to help guide treatment and/or drug therapy changes based on the normal and disease ranges and movement of the marker levels.
The algorithm and clinical content used in the analysis is regularly updated by our leading clinical advisors to reflect the most recent clinical research.
Clinical Study Results with IR2Dx Markers
IR2Dx has one of the largest and most diverse databases among diagnostic companies in the diabetes field. Our clinical studies, demonstrating marker response across all of the major classes of anti-diabetic agents, include over 14,000 patients studied in multiple clinical trial settings (disease stage), and drug combinations. Please see our clinical studies in publications in our Publications & Abstracts section.
An overview of our clinical studies highlights the following:
- Our markers are included in various combinations in the trials, and not necessarily all together.
- Our markers demonstrate major differences between the effects of different classes of anti-diabetic drugs.
- While there was good concordance with glucose control, our markers often demonstrated much earlier response to therapeutic interventional success or deterioration as shown by marker levels and outcomes.
- In many cases, the information about the patient’s response to an individual therapeutic regimen was demonstrated to be independent of whether or not they demonstrated adequate glucose control, with traditional markers like HbA1c or fasting plasma glucose.
Compared with glucose related tests, the underlying TIGAR™ metabolic markers demonstrate better correlation with the patient’s response to the clinical study therapies, as shown by well accepted surrogates markers of response like triglyceride levels, intima media thickness reductions in the arterial walls and LDL levels. These markers are gaining more widely accepted use with new diabetes medications in Phase III and IV outcome studies.