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Significant advances in clinical genetics over the last decade have increased the demand for genetic tests that predict diagnosis and predisposition to disease (1). Moreover, many somatic diseases of genetic origin such as cancer require genetic studies during different phases for diagnosis, prognosis, control of disease progression, prediction of drug response, and monitoring of treatment response. Consequently, the use of genetic tests requires strict laboratory quality assessment (QA) procedures to fulfill clinical requirements.A representative paradigm for higher-standard requirements is the quantification of BCR-ABL1 transcripts in chronic myeloid leukemia (CML)2 to assess the response to treatment with tyrosine-kinase inhibitors (TKIs) such as imatinib or second-generation inhibitors such as nilotinib and dasatinib. The relevance of transcript levels in determining disease prognosis and progression-free survival is clear (2, 3). The TKI treatment goal in CML is to achieve at least a thousand-fold reduction (3 logs) in transcript level from the baseline reference, based on BCR-ABL1 expression levels of the International Randomized Study of Interferon vs ST1571 (IRIS) trial (4, 5). Such a reduction in transcript level is known as a major molecular response (MMR) and is associated with prolonged response to TKI and disease-free progression (2, 3). However, either IRIS trial samples or an international standard must be available to report the final results in international scale (IS) units, allowing harmonization in the reporting of BCR-ABL1 levels for uniform clinical interpretation.To this effect, in 2009, the WHO approved …

Standardized Quantitative Assessment of BCR-ABL1 Transcripts on an International Scale