The Choice of Free Light Chain (FLC) Assay Matters
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Why Choose Freelite® Assays by Binding Site
The choice of serum free light chain (FLC) assays is critical for clinical laboratories aiming to provide a service clinicians can trust. Clinicians require FLC results that are accurate and proven to aid in the diagnosis and monitoring of patients with monoclonal gammopathies (MG), such as patients with Multiple Myeloma.
Download this White Paper to learn why the choice of FLC test matters
Freelite assays were utilised in defining the FLC values recommended in the guidelines for the diagnosis and monitoring of monoclonal gammopathies
The clinical evidence supporting FLC recommendations in the IMWG guidelines are based on Freelite assays. This includes one of the myeloma-defining event criteria (involved / uninvolved FLC ratio ≥ 100, involved FLC ≥ 100 mg/L) and FLC criteria for assigning haematological responses1-2. These recommendations cannot be assumed to apply to FLC assays from other manufacturers.
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Freelite assays are the benchmark - results from other FLC tests are not equivalent for aiding in the diagnosis or monitoring of monoclonal gammopathies 10-12
“Our data […] clearly indicate that clinical FLC thresholds published in guidelines and obtained with Freelite data, do not apply to other FLC assays.”
Fleming et al. Clin Chem Med 2019
“Our study revealed five cases where the only means for diagnosis or detecting disease progression was FLC analysis, and where only one (Freelite from Binding Site) of the two parallel applied methods served to detect the relevant changes.”
Veskovski et al. eJHaem 2024
“Based on our findings, the three different FLC assays should not be used interchangeably.”
Schieferdecker et al. Blood Cancer Journal 2020
Freelite assays are trusted by the medical community worldwide
>3,800
Publications cite Freelite assays in scientific evidence and clinical studies
>1000
Laboratories worldwide choose Freelite assays
>95
%
Globally renowned National Comprehensive Cancer Network choose Freelite assays
Download this White Paper to learn why the choice of FLC test matters
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References
- Rajkumar SV, et al. International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma. Lancet Oncol. 2014; 15:e538-e548
- Kumar S, et al. International Myeloma Working Group consensus criteria for response and minimal residual disease assessment in multiple myeloma. Lancet Oncol 2016; 17:e328-46
- Dispenzieri A, et al. International Myeloma Working Group guidelines for serum-free light chain analysis in multiple myeloma and related disorders. Leukemia 2009; 23:215-224
- NICE. Myeloma: diagnosis and management [NG35]. NICE Guidelines 2016;
- Keren DF, et al. Laboratory Detection and Initial Diagnosis of Monoclonal Gammopathies: Guideline From the College of American Pathologists in Collaboration With the American Association for Clinical Chemistry and the American Society for Clinical Pathology. Arch Pathol Lab Med 2021; 146:575-590
- Kumar SK, et al. Multiple Myeloma, Version 2.2024, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw 2023; 21:1281-1301
- Dimopoulos MA, et al. Multiple myeloma: EHA-ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2021; 32:p309-322
- Comenzo RL, et al. Consensus guidelines for the conduct and reporting of clinical trials in systemic light-chain amyloidosis. Leukemia 2012; 26:2317-25
- Gillmore JD, et al. Guidelines on the diagnosis and investigation of AL amyloidosis. Br J Haematol 2015; 168:207-18
- Fleming CKA, et al. Method comparison of four clinically available assays for serum free light chain analysis. Clin Chem Lab Med 2019; 58:85-94
- Veskovski L, et al. The choice of serum-free light chain analysis method could potentially have clinical consequences for myeloma patients. eJHaem 2024; 5:455-461
- Schieferdecker A, et al. Comparison of three different serum-free light-chain assays-implications on diagnostic and therapeutic monitoring of multiple myeloma. Blood Cancer J 2020; 10:2
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