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Real-time Busulfan Dose Adjustments Now Possible

The MyCare Oncology Busulfan Assay Kit provides rapid results so that busulfan exposure can be reported and acted upon before the next dose

Using body weight alone to determine busulfan dosing is insufficient. With the MyCare Busulfan Assay, receive busulfan drug levels during treatment to greatly increase confidence that optimum exposure has been achieved.

Only 60 – 70% of patients achieve target busulfan exposure when dosed by weight1

Risk to the patient not achieving optimal busulfan exposure (900 – 1340 µM min):2

  • Risks of high exposure:
    • Mucositis
    • Graft vs. host disease
    • Veno-occlusive disease
    • Transplantation-related mortality
  • Risks of low exposure:
    • Graft rejection
    • Disease relapse

 

Improved Outcomes with Busulfan Monitoring

Lower incidence of disease relapse 3 years post transplantation3

Lower incidence of Veno-occlusive disease (VOD):4

    • With real-time dose adjustment: 0 – 5%
    • Without real-time dose adjustment: 24 – 75%

About Busulfan Testing

  • Busulfan is used before hematopoietic stem cell transplantation (HSCT)5
  • HSCT is the standard treatment in various malignant and non-malignant diseases including leukemia (acute and chronic myeloid, acute lymphocytic), non-Hodgkin’s lymphoma, Hodgkin’s disease, metabolic diseases, immunodeficiencies, and hemoglobinopathy
  • Currently, busulfan dosing is determined by a patient’s body weight
  • Busulfan exposure is calculated as area under the time versus concentration curve (AUC)
  • Optimal exposure is essential for successful hematopoietic stem cell transplantation outcomes

References

1. Palmer et al. 2016. Biol Blood Marrow Transplant; 22: 1915-1925.
2. Busulfex Package Insert
3. Slattery et al. 1997. Blood; 89: 3055-3060.
4. Grochow. 1993. Semin Oncol; 20: 18-25.
5. Bartelink et al. 2016. Lancet Haematol; 3: e526-536.

Rapid, accurate, easy to perform diagnostic test

Allows multiple AUCs early in treatment

Parameters available for a wide range of clinical chemistry analysers

Proprietary technology with unprecedented stability of liquid controls and calibrators

CE Marked and Health Canada Licensed

Only commercially available assay

No reagent preparation or sample pretreatment

Validated according to FDA-recognized and IVDD harmonized standards

ISO 13485 and FDA cGMP compliant manufacturing process

Cost effective

Busulfan Assay Performance

Precision Data

Sample Type Assigned Value (ng/mL) N Mean (ng/mL) Repeatability %CV Within-Laboratory %CV
Controls Low 225 80 250 4.6 6.1
Medium 450 80 461 3.1 3.9
High 900 80 910 1.8 2.8
Plasma Spike 1 325 80 328 4.7 5.7
Spike 2 600 80 615 4 4.8
Spike 3 1100 80 1124 2.1 2.9
Spike 4 1500 80 1531 2.6 3.1

Method Comparison

Slope = 0.97, Y-Intercept = 18
Correlation Coefficient (r) = 0.9917, N = 208

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