First CE marked FGF23 ELISA assay launched at Biomedica Immunoassays

The biomarker specialists at Biomedica Immunoassays, announced the launch of the first CE marked FGF23 (C-terminal) ELISA assay which specifically detects both intact and C-terminal fragments of FGF23 in human serum and plasma. The FGF23 ELISA assay complements the existing Biomedica assays directed against chronic kidney disease - mineral and bone disorder (CKD-MBD) in a growing collection. The FGF23 ELISA assay will be an important tool for researchers investigating new biomarkers that could improve prediction of CKD progression, as well as discovery of new drug targets.

The FGF23 ELISA assay provides researchers with a powerful solution for drug discovery and translational research. “In particular, the ability to measure FGF23 in both serum and plasma samples and its stability in both matrices after sample collection opens up a significant new capability to learn about the mechanisms driving FGF 23 elevations in CKD” says Prof. Wolfgang Woloszczuk, CSO of Biomedica Gruppe.

CKD affects millions of people every year, and is rapidly increasing. There is a great unmet need in predicting CKD progression and in gauging the efficacy of treatment options at an individual level. Novel biomarkers are central in personalized medicine and important for improving healthcare in general through earlier diagnostic and better prognosis. The emergence of FGF23 as a potentially modifiable risk factor in CKD has led to growing interest in its measurement as a tool to assess patient risk and target therapy. FGF23 is associated with cardiovascular and renal outcomes in patients with CKD and adds value to risk assessments based on conventional risk factors.

“With the launch of our FGF23 ELISA assay we are another step closer to the vision of identifying biomarkers that will change the way we prevent, diagnose and treat diseases. The Biomedica FGF23 ELISA assay allows anyone with access to human serum or plasma samples to measure FGF23 levels reliably in an efficient way” says Dr. Gottfried Himmler, Head of The Antibody Lab, Biomedica’s partner in immunoassay development.

Biomedica’s FGF23 (C-terminal) ELISA assay is a highly sensitive, fully validated, conventional 96-well ELISA enabling a standardized quantification of FGF23 levels in pmol/l. The assay offers 7 single calibrators and 2 controls in a human serum matrix, thus allowing investigators to collect biologically reliable data. All reagents are included in the kit and the assay can easily be adapted for automation.