Have you ever wondered if you can get more precise and accurate results in kidney diagnostics?
One of the keys to greater precision in treatment of patients with kidney disease is the integration of GFR Measurement in clinical routine. Measured Glomerular Filtration Rate (mGFR) based on Iohexol-Plasma-Clearance ist considered by the European Medicines Agency (EMA) as the benchmark in kidney diagnostics:
“The gold standard for assessment of renal function is a measured GFR using an exogenous substance as a filtration marker (e.g., … iohexol). Methods for estimating GFR (eGFR) using endogenous markers have different drawbacks and are not considered as accurate as measured GFR”.
Nephrolyx IVDx: GFR Measurement in Clinical Routine
Nephrolyx GmbH, a German company, has developed an innovative tool for measuring GFR in clinical routine. The Nephrolyx IVDx combines an IVD kit with a digital platform and is ready-to-use.
Applying Iohexol-Plasma-Clearance method, this test delivers results within just a few hours. It empowers physicians to precisely detect renal diseases and to adjust treatment plans for patients right on time.
Nephrolyx IVDx is recommended for clinical, analytical, and research laboratory settings that use semi-automatic processing in a UHPLC or HPLC device.
The test is not only suitable for both acute and non-acute patient scenarios but also highly adaptable to various clinical situations.
Precise
Nephrolyx IVDx offers superior precision and accuracy in results compared to GFR estimates. Additionally, the test consistently performs accurately in all situations across the GFR range, enabling the early detection of changes in GFR. Moreover, it is not affected by non-GFR determinants.
Affordable
Nephrolyx IVDx stands out as a cost-effective option when compared to other mGFR solutions, including Creatinine-Clearance, 99mTc-DTPA, lab-developed mGFR tests (LDTs), and even several biomarker-based estimates (eGFR).
Rapid
Nephrolyx IVDx provides clinical results within the same day, with a turnaround time of less than 6 hours, which is significantly quicker than LDTs for mGFR.
Obtaining diagnostic results more quickly accelerates and simplifies sample processing.
Medical Endorsements of the Nephrolyx IVDx
Reviews from recognized nephrology experts:
Accurate knowledge of kidney function is critical for identifying correct dosing of numerous drugs given to the critically ill and for the identification of patients at risk of long term kidney disease, who currently miss opportunities for appropriate treatment and follow-up.
Plasma Iohexol clearance is widely accepted as a contemporary gold standard for the measurement of kidney function (GFR), but has been difficult to operationalise in complex clinical settings. Nephrolyx is innovating technology and systems to bring iohexol measured kidney function to real world clinical medicine. I believe Nephrolyx has potential to fill the existing diagnostic gap in a practical and efficient fashion, which could revolution kidney care during and after critical illness”.
Consultant in Intensive Care & Renal Medicine
Adult Critical Care Unit
Royal London Hospital
Barts Health NHS Trust
London, UK
However, these equations share the same degree of imprecision. In specific population (like in ICU patients, cirrhosis, transplanted patients etc.) the performance of such equations is really very poor. Also, in some specific clinical situations, a high degree of precision for GFR result is required, like for the decision of kidney donation or the dosage adaptation of nephrotoxic drugs.
Simplified but highly reliable methods are available to measure GFR with a high precision. Among them, iohexol plasma clearance is certainly the best balance between availability, physiology and feasibility. Easy protocols are available in the literature and the analytical performance of methods to measure iohexol is excellent”.
University of Liege
CHU Sart Tilman
Liege, Belgium
For the first time, Nephrolyx offers a commercially available robust and easy to use solution for iohexol determination. This approach does not necessitate big knowledge in chromatography and can be quickly and easily set up in any clinical lab, offering a reference method to clinicians.
Turnaround and hands-on time are particularly limited for the excellent analytical performance”.
Chairman of the IFCC Committee for Bone Metabolism (C-BM)
Chairman of the EFLM Task Group on Chronic Kidney Diseases (TG-CKD)
General Secretary of the European Society for Clinical and Economical Aspects of Osteoporosis and Musculoskeletal Diseases (ESCEO)
Head, Department of Clinical Chemistry University of Liege, CHU de Liege
Liege, Belgium
Nephrolyx is addressing this unmet nephrological need using a proven reliable iohexol-based approach."
Renal Unit Guy’s & Saint Thomas’ Hospital London
London, UK
GFR Measurement in Clinical Routine: Benefits
For physicians
- Confidence in accurate results
- Quicker clinical decision possible
- Ability to identify early changes in GFR
- Optimized patient treatment expected
- Easy access to mGFR
For laboratories
- Higher workflow automation and better performance compared to LDTs
- Regulatory compliance
- Seamless software integration
- Access to mGFR for all clinical departments
Nephrolyx DNPx Demo Trial
The GFR is calculated using pharmacokinetic algorithms integrated into the Digital Nephrology Platform – DNPx, developed by Nephrolyx. Multiple-sample protocols (two-sample minimum) and the single-sample protocol can be utilized by the user in DNPx. Patient samples are used to calculate the mGFR with the iohexol concentrations obtained from (U)HPLC measurements.
If you are interested in experiencing the DNPx functionalities, contact us to set up a 2-week demo trial to utilize the software online.
Nephrolyx is the leading provider of GFR measurement in clinical routine. The company builds on 12 years of research in the field of kidney function diagnostics at Charité Universitätsmedizin Berlin.
Nephrolyx’s mission is to optimize patient outcomes by providing physicians and researchers with access to GFR measurement. Addressing challenges in kidney diagnostics, the company thoroughly works to enhance patient treatment in both hospital and ambulatory settings.
Moreover, Nephrolyx is dedicated to fostering innovation in the field, supporting the development of new medications and assisting pharma and biotech companies in kidney research and clinical trials. The company aims to enable precision medicine in healthcare worldwide.
