Serial analysis of BCR-ABL1 transcript levels in CML patients is currently the most sensitive and cost effective way for monitoring treatment efficacy. MolecularMD’s quantitative PCR assay enables detection of the most common e13/14 (b2/3) transcripts on the International Scale to report Major Molecular Response (MMR) levels. In patients that have undetectable levels of BCR-ABL1, the assay can attain a sensitivity of 4.5 logs for reporting Complete Molecular Response (CMR). MolecularMD’s BCR-ABL1 quantification service was used for monitoring molecular responses in the pivotal clinical trials that supported registration of the 2nd generation ABL1 TKIs, nilotinib and dasatinib, as well as upcoming 3rd generation TKIs such as ponatinib.
MolecularMD has designed and validated bi-directional Sanger sequencing assays to identify mutations in the p210 and p190 transcripts of the BCR-ABL1 fusion gene. Our assay spans an extended region including the kinase and SH2-SH3 regulatory domains and is able to detect over 40 amino acid substitutions including the T315I mutation. The MolecularMD Clinical Laboratory offers sensitive, reproducible and highly specific BCR-ABL1 mutation testing to aid in patient selection for appropriate therapy and potential monitoring of treatment efficacy.