Covered by Medicare! for Puerto Rico!
CPT 0385U
DOCTORS
If you are a medical professional, in this section you will find the most important information about this technology. It is very important to note that INNOVATIO ND2 ™: the ELISA test developed by OMICS Global Solutions was validated by Proteomics International (PI), on a mass spectrometry (MS/MS) platform and the results provided by this ELISA test are Clinically Equivalent to those obtained in MS/MS.
How to read the results of INNOVATIO ND2?
The results of the test are shown together with other clinical variables used to calculate the risks both Diagnosis and Prognosis of the patient using the PromarkerD™ algorithm.
Based on the test cutoffs, they are displayed as follows:
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Low Risk: requires standard diabetes management. This stage must be monitored every year.
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Medium Risk: The optimization of risk factors is recommended: lifestyle, management of glycemic targets, etc. Also, non-glycemic factors including blood pressure and lipids. The use of potentially nephro-toxic drugs should be avoided. It is recommended to use those withevidence of nephro-protection. This stage should be monitored every 3 to 6 months.
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High Risk: Requires more frequent monitoring and intensive management strategies based on those of "moderate risk" (already mentioned in the previous range) with optimization of treatments for diabetes and other risk factors. This status must be monitored every 3 months*
Prognostic Risk score of 16% Indicates a moderate risk of developing diabetic kidney disease*.
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Diagnostic: 40%. Indicates patient already has renal disease.
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Note: >30% indicates that patient already has renal disease. In this case, the Prognostic score will indicate the speed of progression. Low risk means "slow progression", Moderate means "faster than usual" and High risk "accelerated progression"
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NOTE: through the commercial or clinical representatives of Omics Global Solutions in the different countries, the CLINICAL GUIDE edited by the company is delivered, containing the recommended clinical approach according to the latest management guidelines for Nephropathy prevention in type 2 Diabetic patients.
PUERTO RICO/US VIRGIN ISLANDS PHYSICIANS
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HERE you will find the model of Medical Order (prescription) to give to your patient
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CURRENT PROBLEM
It is important to diagnose diabetic kidney disease early, as this allows the patient to take steps
to protect their kidneys from further damage.
There is currently no other test to predict a patient´s risk of developing diabetic kidney disease.
The current gold standard tests to diagnose diabetic kidney disease are:
Urine test (measurement of ratio: albumin-creatinine "ACR")
Blood test (which measures serum creatinine that is used to estimate glomerular filtration rate
"GFR")
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The shortcomings of the current gold standard tests are:
They can only detect diabetic kidney disease when kidney damage has already occurred.
They are not always reliable or definitive in establishing the diagnosis.
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CLINICAL UTILITY
INNOVATIO ND2 ™, enables a more comprehensive assessment and informed approach to help:
1. Identify patients at risk of developing ERD in the next four years.
2. Implement preventive measures before kidney damage occurs.
3. Customize patient treatment plans.
4. Improve patient monitoring and management.
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What can be done?
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Early-stage chronic kidney disease can be treated through dietary changes, lifestyle
modifications, and the appropriate selection of medications to control blood pressure and
other comorbidities that patients may have, ensuring a better quality of life and a decrease in
the risk of kidney failure in the short, medium or long term, depending on each patient.