|Epic Lab Code:||LAB7393|
|Downtime Form:||A-1a Molecular Pathology/Diagnostics Laboratory Requisition|
6004 BT GH
|Pink top tube 6 mL (K2-EDTA)||Lavender top tube 3 mL (EDTA)||Lavender top tube 3 mL (EDTA)|
Major Molecular Response (MMR) reflects a patient's response to CML treatment and MMR is defined as greater than or equal to a 3-log reduction in BCR-ABL/control gene ratio from a standardized median baseline value. In the International Randomized Interferon versus STI571 (IRIS) study, patients with a ratio at or below MMR within 18 months of starting treatment were 100% free from progressing to accelerated phase or blast crisis at 60 months. The laboratory employs an MMR reference value that has been validated with the WHO International Standard.
Interassay Variability: Above MMR: less than 2-fold, Below MMR: less than 4-fold
Sensitivity: One tumor cell in 1 x 104 normal cells
Limit of Quantitation: 30 BCR-ABL copies
The laboratory reports the BCR-ABL/ABL raw ratio, the percent ratio standardized to the International Standard (%IS), the BCR-ABL copy number, and the ABL copy number as separate values that can be trended using Epic graph function. Breakpoint determination will be performed and reported for new diagnosis specimens only.
Specimens Requiring Immediate Delivery