Nephrolyx provides the IVDx system, combining an IVD kit with a digital platform for routine Glomerular Filtration Rate (GFR) measurement. This solution utilizes the Iohexol-Plasma-Clearance method to deliver precise, same-day mGFR results for clinical settings. The offering supports physicians in accurate renal disease detection and optimized patient treatment planning, while streamlining laboratory workflows.
Funding
Funding not disclosed
Founders
Product
Problem
Current methods for assessing Glomerular Filtration Rate (GFR), a key indicator of kidney function, often rely on estimations using serum creatinine, which can be inaccurate, especially in specific patient populations or clinical situations. Precise GFR measurement is critical for accurate drug dosing, assessing kidney donation suitability, and early detection of kidney disease progression. Existing methods for measured GFR (mGFR) can be complex, time-consuming, and lack standardization across clinical settings.
Solution
Nephrolyx provides a ready-to-use in-vitro diagnostic (IVD) kit and digital platform, Nephrolyx IVDx, for measuring GFR based on Iohexol-Plasma-Clearance, considered a gold standard by the European Medicines Agency (EMA). The Nephrolyx IVDx combines an IVD kit with a digital platform and is designed for clinical, analytical, and research laboratories using semi-automatic processing with UHPLC or HPLC devices. This solution delivers precise GFR results within a few hours, enabling physicians to detect renal diseases accurately and adjust treatment plans promptly. Compared to traditional mGFR solutions and eGFR estimates, Nephrolyx IVDx offers a cost-effective and rapid method for obtaining accurate GFR measurements, improving the management of patients with or at risk of kidney disease.
Target Audience
The primary target audience includes clinical laboratories, nephrologists, and hospitals seeking precise and rapid GFR measurement for improved diagnosis and treatment of kidney diseases.
Features
- IVD kit utilizing Iohexol-Plasma-Clearance for mGFR measurement
- Digital platform for data analysis and reporting
- Results available within 6 hours, facilitating same-day clinical decision-making
- Suitable for both acute and non-acute patient scenarios
- Compatible with semi-automatic processing in UHPLC or HPLC devices
- Compliant with regulatory standards
- Seamless software integration capabilities