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

We invite you to view our webinar with Dr. John Mitsios, PhD, as he discusses the potential clinical usage of the N-Latex FLC assay in evaluation of MGUS.

Learning Objectives:

  • Define multiple myeloma and monoclonal gammopathy of undetermined significance (MGUS)
  • Describe the clinical criteria used to define multiple myeloma
  • Describe the use of free light chains in the evaluation of MGUS


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.

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

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