NEuroBioStand project launched for Europe-wide comparability of innovative biomarkers
Berlin – Labor Berlin, a subsidiary of Charité and Vivantes, is the first laboratory to introduce the determination of NfL in both cerebrospinal fluid and serum as a routine parameter within the scope of regular health insurance coverage for patients.
Neurofilament light chain from serum as a biomarker for nerve cell damage
Neurodegenerative diseases have a significant impact on patients’ lives. Early and precise diagnosis in these cases can be particularly important for the quality of life of those affected. This is made possible, among other things, by the determination of neurofilament light chain (NfL) in serum, e.g. in ALS (amyotrophic lateral sclerosis) or frontotemporal dementia. The measurement of NfL is currently only possible in a few laboratories.
What makes the determination so valuable as a routine parameter?
The detection of NfL from serum only requires a standard blood sample for diagnosis. This can be done by any doctor and can help to provide a more targeted indication for a lumbar puncture if necessary. However, as the concentration of NfL in serum is much lower, a special, highly sensitive measuring method is required, the so-called Single Molecule Assay from Quanterix®.
Why are uniform standards so important?
PD Dr. med. Péter Körtvélyessy, expert in biomarkers in neurology and project manager for innovative neurological developments at Labor Berlin, heads a working group of the EU-funded NEuroBioStand project (start: 01.10.2023). This has set itself the goal of introducing uniform standards for different neurological determination methods – including for NfL. The comparability of the different methods ensures that the measured value per method is the same in all laboratories. Such standardized tests avoid fundamental misdiagnoses – is it a fatal disease or a normal finding? – and thus ensure particularly reliable results for patients. For routine measurements, Labor Berlin takes part in so-called interlaboratory tests. For new, innovative biomarkers, such as NfL, these standards must first be defined. Labor Berlin will now provide active support in meeting the standards set for these new values and the new measurement methods.
What does this mean for healthcare in Germany?
With the routine determination of neurofilament light chain from serum, Labor Berlin is one of the few clinical laboratories in the world that can offer the important biomarker neurofilament light chain (NfL) to all senders outside of research and under accredited conditions. Neurofilament Light Chain in serum has already become an important biomarker beyond neurology, e.g. in pediatrics, oncology or intensive care medicine.
