Table 3.

Reporting Recommendations for BCR-ABL KD Mutational Analysis

Pre-analytic

Clinical indication (including current and/or past TKI therapy, if available)

Tissue source (e.g. peripheral blood, bone marrow aspirate)

Most recent BCR-ABL RQ-PCR results or trend data (if available)

Analytic

Methods description including region that is sequenced, with assay sensitivity and controls

BCR-ABL amplification and control results (acceptable/fail)

Mutation not detected

Mutation detected: amino acid change (e.g., T315I), and relative abundance of mutation (e.g., mixed mutated/unmutated) [inclusion of nucleotide change is optional]

Other sequence alterations (e.g., ins/del, known SNP)

Post-analytic

Comment if mutation is known to confer clinical and/or in vitro resistance to a particular TKI, with appropriate reference

Comment if novel mutation(s) identified and denote lack of published clinical or laboratory data concerning its TKI resistance profile