Beckman Coulter Partners with BioPorto for Global Distribution of Acute Kidney Injury NGAL Tests

By LabMedica International staff writers
Posted on 30 Oct 2024

Image: The NGAL Test quantifies NGAL levels in human urine, EDTA and heparin plasma (Photo courtesy of BioPorto)

Acute kidney injury (AKI) is a sudden episode of kidney failure or damage that can occur within a few hours or days. This condition leads to the accumulation of waste products in the blood and disrupts the kidneys' ability to maintain the balance of bodily fluids. Additionally, AKI can impact other organs, including the brain, heart, and lungs, and is particularly common among patients in hospital intensive care units. If not recognized and treated promptly, AKI can result in serious complications, including considerable morbidity and mortality. Now, a new partnership seeks to enhance the early detection of AKI by improving the global accessibility of assessment tests for this condition.

Beckman Coulter (Brea, CA, USA) and BioPorto (Copenhagen, Denmark) have entered into a global distribution partnership which will allow Beckman Coulter to distribute BioPorto’s neutrophil gelatinase-associated lipocalin (NGAL) tests for use with the DxC and AU series of clinical chemistry analyzers. BioPorto’s products are based on the NGAL biomarker and are intended to assist in assessing risk and diagnosing AKI. The NGAL biomarker levels rise quickly following kidney injury, often indicating problems 2 to 3 days before any changes in creatinine levels are observed, and it has been demonstrated to provide early clinical decision support for patient management. The NGAL biomarker has been investigated in over 16,500 patients across various settings, including post-cardiac surgery, critical illness, and after kidney transplantation.

BioPorto’s ready-to-use enzyme-linked immunosorbent assay (ELISA) kits quantify NGAL levels in urine, plasma, and serum. By measuring NGAL levels, healthcare providers can more swiftly identify patients at risk of AKI compared to current standard care measurements. Early identification allows clinicians to take timely actions to manage fluid levels, avoid nephrotoxic agents, and potentially prevent irreversible kidney damage. According to the agreement, Beckman Coulter will first distribute BioPorto’s NGAL test in Europe, with plans for distribution in the United States pending U.S. Food and Drug Administration (FDA) marketing clearance for ProNephro AKI (NGAL) on Beckman Coulter’s analyzers. The partnership also opens the door for expansion into additional geographic regions.

“We are excited by this new partnership with BioPorto on AKI assays underscoring the clinical importance and demand of NGAL as a biomarker,” said Kathleen Orland, Senior Vice President and General Manager, Clinical Chemistry and Immunoassay, of Beckman Coulter. “We look forward to now being able to offer BioPorto’s NGAL assay on our global installed base to improve kidney health management worldwide.”

"Entering into this agreement with Beckman Coulter represents a significant milestone in our partnership portfolio,” added Peter Mørch Eriksen, Group CEO of BioPorto. “Beckman Coulter is renowned for its innovative instruments and its ability to seamlessly integrate partner assays and technologies into its analyzer family. At BioPorto, our mission is to empower healthcare professionals to address the substantial unmet medical needs of patients at risk of AKI. By expanding our distribution network, enhancing the portfolio of instruments capable of running our tests and securing collaborations with leading global manufacturers, we are well-positioned to accelerate the adoption of our AKI assessment tests. This partnership with Beckman Coulter underscores the compelling value of our technology and our commitment to improving patient outcomes.”

Related Links:
Beckman Coulter
BioPorto