The only Free Light Chain assay with FDA clearance for evaluation of MGUS
The Siemens Healthineers N Latex FLC Assay is FDA cleared for the Evaluation of patients with MGUS*
Free light chains, kappa (κ) lambda (λ), are produced by plasma cells and known to be an important marker in patients with Multiple Myeloma and AL Amyloidosis. The precursor condition to Multiple Myeloma is called Monoclonal Gammopathy of Undetermined Significance (MGUS) and although these individuals are not immediately treated, they are closely monitored due to their risk of progression to Multiple Myeloma.8
The N-Latex FLC Assay Difference
The N Latex FLC assay for Free Light Chains uses multiple monoclonal antibodies for detection and is reported to have no false positive κ/λ ratios in patients with renal impairment5-7. Since renal impairment may confound MGUS diagnosis, the low false positive rate of the N Latex FLC assay compared to other assays 5-7 provides confidence that abnormal FLC ratio is truly due to a monoclonal disorder.
The N-Latex FLC Difference
Siemens N Latex FLC | The FLC Competition |
More consistent results (Multi-Monoclonal antibody based) | More variability (and drift, polyclonal antibodies) |
Guideline recommended technology (nephelometry) | Assay is mentioned in the IMWG Guidelines, but the technology (turbidimetry) is not |
NO unnecessary bone marrow biopsies (no false positives) | Unnecessary bone marrow biopsies (false positives) leading to patient discomfort and extra cost |
FDA cleared for the largest population precursor disease – MGUS | Not FDA Cleared for evaluation of MGUS |
Cost efficiencies – order what you need Options for Automated and standalone | Wasted reagents – bundled kit |
By clicking Submit you consent to the processing of your above given personal data by the Siemens Healthineers company referred to under Corporate Information and for the purpose described above. Further information concerning the processing of your data can be found in the Data Privacy Policy. You are aware that you can partially or completely revoke this consent at any time for the future. Please declare your revocation to the contact address given in the Corporate Information and sent it to us via the following e-mail address: dataprivacy.func@siemens-healthineers.com
Did this information help you?
*in addition to diagnosis and monitoring of patients with Multiple Myeloma and diagnosis of patients with AL Amyloidosis
Kyle et. al. NEJM 2006
Seer.cancer.gov 2021
Rajkumar et. al. Blood 2005
Gran et. al. Am J. Hematol. 2021
Jacobs et. al. Clin Chem Lab Med 2014
Rindlisbacher et. al. J Applied Lab Med 2020
Sprangers et. al. Kidney International Reports 2020
Kyle et. Al. Leukemia 2010