IN VITRO DIAGNOSTIC
Our dedicated approach to identify and target biomarkers addressing unmet clinical needs in the management of acute conditions has enabled us to offer a novel biomarker for the diagnosis of acute kidney injury. We have launched The NGAL Test, a market leading unique immunoassay solution for early risk assessment of acute kidney injury in several medical and surgical specialties.
The NGAL Test and NGAL ELISA Kit 036 are not available in the USA for in vitro diagnostic use.
Our dedicated focus on the development of antibodies for research on nephrotoxicity has resulted in a unique range of available NGAL animal and human antibodies, which enables;researchers to focus on kidney damage throughout the drug development process ;hereby we have been able to bridge the gap between drug discovery, pre-clinical research and human clinical trials.
LETTERS OF SUPPORT
FDA and EMA have recently released letters of support for the use of NGAL in non-clinical analyses and exploratory clinical analyses. View letters of support here: FDA & EMA
NGAL has been used in several research studies - for a major research study for our NGAL kits please see overview:
Particle-enhanced Turbidimetric Immunoassay (PETIA)
Application: Roche Cobas, Siemens ADVIA etc.