Monoclonal Gammopathy of Undetermined Significance (MGUS)
Freelite enables risk stratification of MGUS Patients *
An abnormal serum free light chain ratio has been identified as an important, independent risk factor for progression of MGUS to myeloma or related malignancies.
Monoclonal gammopathy of undetermined significance is an asymptomatic condition that occurs in 1% of the population over 50 years of age, and >3% over 70 years of age. It is traditionally associated with the presence of a low level monoclonal band (<20g/L) in the serum, usually no light chains in the urine and <5% plasma cells in the bone marrow. Monitoring of MGUS patients is essential as a significant percentage (approximately 1% per annum) progress to develop Multiple Myeloma or related malignant condition.
Risk stratification
In a recent study of 1148 MGUS patients seen at the Mayo clinic between 1960 and 1994, an abnormal serum kappa/ lambda ratio was identified as a major independent risk factor for progression of MGUS to myeloma or a related malignancy1.
This risk stratification identified a low risk subset (40%) with a remarkable small life-time risk of progression, only 2% over 20 years.
| Risk group | Numbers of Patients | Absolute risk of progression at 20 years** |
|---|---|---|
| LOW (serum M protein <15 mg/dL, IgG subtype, Normal FLC ratio) |
449 | 2% |
| LOW INTERMEDIATE RISK (Any 1 factor abnormal) |
420 | 10% |
| HIGH INTERMEDIATE RISK (Any 2 factors abnormal) |
226 | 18% |
| HIGH RISK (All 3 factors abnormal) |
53 | 27% |
| ** accounting for death as a competing risk | ||
Freelite and MGUS patient management

Serum concentrations of free light chains in MGUS patients as predictors of progression to malignancy. A preliminary study of 97 MGUS patients2.
Freelite can contribute to the management of your MGUS patients.
- Low risk patients may account for 40% of all MGUS patients1.
- Freelite enables you to provide reassurance to low risk MGUS patients.
- High risk patients may account for 5% of all MGUS patients1.
- Freelite enables you to identify high risk patients and monitor more closely.
- Risk stratification of MGUS patients with Freelite will enable you to allocate resources appropriately.
- Download Review - Clinical Laboratory International, Dec 2005 - Code MKG301 as published in Clinical Laboratory International, December 2005. Click here to visit the CLI website.
- Download Literature - MGUS - Code MKG276
- Download FRENCH Literature - MGUS - Code MKG292
* In the USA diagnostic use of this product is restricted to those stated in the product insert

