Health Canada has approved the use of two tests designed to detect BCR-ABL transcripts in patients with chronic myeloid leukemia (CML)—the MRDx® BCR-ABL Test and the QuantideX qPCR BCR-ABL IS Kit.
MolecularMD’s MRDx® BCR-ABL Test is approved as an aid to monitor tyrosine kinase inhibitor (TKI) therapy in Philadelphia chromosome-positive CML patients.
This test is also approved to identify CML patients in the chronic phase being treated with nilotinib who, after sustaining a deep molecular response of MR4.5, may be eligible to stop treatment and be monitored for treatment-free remission.
Asuragen, Inc.’s QuantideX qPCR BCR-ABL IS Kit is approved for use in CML patients, regardless of whether they are taking a TKI or how their disease is being managed.
The kit is designed to detect and quantify major breakpoint (e13a2, e14a2) BCR-ABL1 fusion transcripts for use in monitoring molecular response.
Both the MRDx® BCR-ABL Test and the QuantideX qPCR BCR-ABL IS Kit are approved in the United States as well.
The QuantideX qPCR BCR-ABL IS Kit is also CE marked for clinical use in the European Union.