The tests from Asuragen and MolecularMD are designed for use in chronic myeloid leukemia patients, including those receiving tyrosine kinase inhibitor therapy.
The companion diagnostic test identifies patients taking the Novartis drug Tasigna who are candidates for treatment-free remission monitoring.
The researchers plan to develop a clinical test to monitor CML patients in remission for the BCR-ABL1 rearrangement.
Asuragen test kits to detect major and minor BCR-ABL fusions can now run on the Roche Diagnostics Cobas z 480 Analyzer.
The test measures minimal residual disease and can be used to monitor patients eligible for discontinuation of treatment with Tasigna.
The test uses droplet digital PCR to detect BCR-ABL gene fusions and is intended for treatment response monitoring of chronic myeloid leukemia.
The molecular test is now the first FDA-cleared assay to monitor treatment response and disease clearance in chronic myeloid leukemia patients.
Digital PCR can better detect low levels of chronic myeloid leukemia in patients than other PCR-based approaches, according to Imperial College London researchers.
The assay improves upon other tests by attaining a sensitivity of MR4.7 while it allows direct reporting on the IS, Asuragen said.
NEW YORK (GenomeWeb) — Using PCR-based methods to detect mutations in the BCR-ABL1 kinase domain of chronic myeloid leukemia patients has been established as a critical tool for monitoring CML patient response to tyrosine kinase inhibitor therapy.
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In PLOS this week: genes that help Borrelia burgdorferi survive in ticks, CiliaCarta collection of about 1,000 suspected cilia genes, and more.