Biomedica Launches First CE Marked FGF23 ELISA Assay In Europe and Asia

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.

About Biomedica Gruppe
Biomedica Immunoassays was created in 1988 as the R&D business unit of Biomedica Gruppe and provides internationally recognized, high quality ELISAs for clinical research in the field of cardiovascular diseases as well as bone and mineral disorders.

Biomedica’s customers include numerous top ranking scientific institutions worldwide, well-known CROs and laboratories in the pharmaceutical industry. The company is dedicated in setting the standard for clinical research and provides high quality and fully validated assays with serum-based calibrators and controls. Biomedica’s experienced and qualified team of professionals is recognized by its outstanding technical and scientific support. The majority of the Biomedica’s assays are CE marked and ready for use in IVD. The company’s manufacturing processes comply with ISO 9001:2008 management system standards and conform to GMP/GLP guidelines. Biomedica has become a world-wide market leader with a continuously growing portfolio which includes NT-proBNP ELISA, ENDOSTATIN ELISA, and SCLEROSTIN ELISA. Biomedica Immunoassays maintains distribution operations worldwide.

(Source: B3C newswire)

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