A study on the real-world implementation of routine neurofilament light chain (NfL) diagnosis for multiple sclerosis in German laboratories shows that the biomarker is reliable and robust, with strong pre-analytical properties. The range of tests is growing due to increasing laboratory capacities and clinical demand, especially for MS and other diseases. The appropriate testing frequency for MS patients is still being researched.

The study, sponsored by a large pharmaceutical company, is based on interim data from the first half of 2025 from six diagnostic laboratories in Germany. Up to four more laboratories are to be added by the end of 2025. A total of 9264 sNfL measurements were documented, of which 2541 were in the first quarter and 6723 in the second. The samples came from a real, predominantly female patient population of all age groups, with 32 percent MS diagnoses.

All analyses were carried out on serum samples, 1.3 percent were rejected due to poor quality. The measurements were carried out with three different assays and platforms, and the results were partly reported back with reference values or additional information. The median value was 10.3 pg/ml, the mean value was 35.6 pg/ml, 84.5 percent of the values below or equal to 20 pg/ml. About one-third of the samples were shipped between labs, which poses risks such as miscommunication or loss of context.

sNfL is considered a non-specific marker of neurodegeneration and requires clinical context as well as age-dependent references for interpretation. The concentrations rise sharply from the age of 60. 91.6 percent of the measurements were initial examinations, only 8.4 percent follow-up measurements. Longitudinal monitoring and collaboration between laboratory physicians and treating physicians are essential for clinical decisions.

The samples came from practices, other laboratories and clinics, with neurologists as the most frequent requesters. The average processing time was 1.5 days, measurements took place on 2.8 days per week. The results underline the growing relevance of sNfL in Germany, with increasing availability of assays and increasing requests.

Important details can be seen as posters at the DKLM 2025 in Leipzig. Interested media can receive the poster in advance in compliance with the strict embargo period of 23.10.2025 / 00:01 and presentation of a valid press card. To do so, send us your enquiry including a copy of your press card to: redaktion@medlabportal.de

The German Congress of Laboratory Medicine (DKLM) 2025 promises exciting insights into the interface between science and clinical practice. Under the motto “Science for Precision Medicine”, the German Society for Clinical Chemistry and Laboratory Medicine (DGKL) and the Umbrella Association for Technologists and Analysts in Medicine Germany (DVTA) invite experts from research, clinics and industry to meet on October 23 and 24 at the Congress Center Leipzig (CCL). The two-day event is aimed at laboratory physicians, biomedical analysts and decision-makers to discuss current advances in diagnostics and strengthen networks. The ceremonial opening of the congress will take place on 22 October with the presentation of the MedLabAwards in the Salles de Pologne.

Editor: X-Press Journalistenbüro GbR

Gender Notice. The personal designations used in this text always refer equally to female, male and diverse persons. Double/triple naming and gendered designations are used for better readability. ected.